GSK1358820 is a botulinum neurotoxin A complex that has been approved for the treatment of overactive bladder (OAB) in several countries, however, it has not been approved for OAB treatment in Japan. This study has been planned to evaluate the efficacy and safety of GSK1358820 in Japanese OAB patients with urinary incontinence whose symptoms have not been adequately managed with other medications for OAB. The primary objective of this study is to evaluate the superiority of a single dose treatment of GSK1358820 100 units (U) compared with placebo. The study comprises a screening phase up to 28 days, followed by a double-blind treatment phase of 12 to 48 weeks wherein subjects will receive a single treatment of either GSK1358820 100 U injection or Placebo injection, in a ratio of 1:1, with further stratification within the treatment arms according to the number of urinary urge incontinence episodes during screening. Subjects meeting the criteria for re-treatment will receive a second and third treatment. Each re-treatment will be with open-label GSK1358820 100 U injection, and will be spaced at least 12 weeks from the previous treatment. The total duration of participation for any subject will not exceed 52 weeks, including screening and the 48-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
GSK1358820 injection contains botulinum toxin type A (100 U), sodium chloride (0.9 milligrams \[mg\]), and human serum albumin (0.5 mg). 10 mL of the drug will be injected at 20 sites (0.5 mL at each site) in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered under local anesthesia, via cystoscopy. Permitted anesthesia options for cystoscopy are intraurethral lidocaine (or similar) gel, and for treatment administration, installation of 1-2% lidocaine (or similar anesthetic) into the bladder.
Placebo injection is made up of sodium chloride (0.9 mg). 10 mL of the injection will be injected at 20 sites (0.5 mL at each site) in the detrusor muscle, spaced approximately 1 cm apart. The injection will be administered under local anesthesia, via cystoscopy. Permitted anesthesia options for cystoscopy are intraurethral lidocaine (or similar) gel, and for treatment administration, installation of 1-2% lidocaine (or similar anesthetic) into the bladder.
Subjects will use prophylactic antibiotic therapy approved for the indication of UTIs, at the discretion of the investigator, with the exception of those in the class of aminoglycosides. The therapy will begin 1 to 3 days prior to the administration of study treatment, and continue for 1 to 3 days following the treatment.
The bladder diary is a self-reporting tool to record subject's data on micturition. Subjects will enter data in the diary over 3 consecutive days. During Screening, data will be collected within 28 days prior to first treatment. During treatment periods, data will be collected within a week prior to each scheduled visit. The bladder diary will capture the following information: 1) Date and time of urinary episode, 2) episodes of micturition, 3) episodes of urinary incontinence, 4) episodes of urgency, 5) intensity of urgency, 6) episodes of nocturia, 7) use of CIC, and 8) urine volume. Diary data will not be collected when a subject experiences symptoms of a UTI.
The KHQ will assess the impact of urinary incontinence on QOL. It is a questionnaire with 21 items and the following 9 domains: 1) General health, 2) Incontinence impact, 3) Role limitations, 4) Physical limitations, 5) Social limitations, 6) Personal relationships, 7) Emotion, 8) Sleep/energy, 9) Severity measure. The items are answered by subjects themselves, and scores are summated using a defined algorithm.
The OABSS will comprehensively assess symptoms of OAB, such as frequency of micturition, nocturia, urinary urgency, and urge incontinence. It consists of 4 questions which will be responded by subjects themselves, by selecting the most appropriate answer for each question.
The TBS consists of one question ("My condition has"), to which the subject will answer by selecting one of the following responses: greatly improved, improved, not changed, worsened. The TBS will assess treatment benefit of GSK1358820.
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Fukui, Japan
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of accidental urinary leakage divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3- day diary assessment which has at least one valid diary day. Change from Baseline is any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.
Time frame: Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment
The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.
Time frame: Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS2 Population comprised all randomized participants who had at least 1 post-2nd treatment efficacy assessment after 2nd treatment.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS3 Population comprised of all randomized participants who had at least 1 post-3rd treatment efficacy assessment after 3rd treatment.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes
The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes
The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes
The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes
The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes
The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes
The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids
The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids
The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids
The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids
The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids
The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids
The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition
The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition
The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition
The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition
The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition
The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition
The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes
The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes
The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes
The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes
The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes
The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes
The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of "Yes" response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes
Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes
Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes
Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes
Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes
Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes
Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes
The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes
The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes
The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes
The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes
The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes
The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity
The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity
The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit.
Time frame: Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity
The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit.
Time frame: Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline
Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline
Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline
Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. "Maximum" was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of "Did you have accidental urinary leakage?" divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of "Did you have accidental urinary leakage?" divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of "Yes" response to the diary question of "Did you have accidental urinary leakage?" divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes
Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1)", excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Time to Qualification for Retreatment
Participants were considered for re-treatment beginning at the Week 12 visit following the initial treatment or the Week 12 visit following any re-treatment. Qualification criteria was; participants must have initiated request for re-treatment, participants experienced \>=2 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day, post-void residual (PVR) urine volume must have been \<200 milliliter; investigator deemed re-treatment appropriate. Time to the participant's first qualification for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants fulfilled the qualification for retreatment criteria minus the day of first treatment plus 1.
Time frame: Up to 36 weeks in Treatment Cycle 1
Treatment Phase 1 (Treatment Cycle 1): Time to Request for Retreatment
The time taken by the participants to request re-treatment was reported. Time to the participant's first request for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants requested retreatment minus the day of first treatment plus 1.
Time frame: Up to 36 weeks in Treatment Cycle 1
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores
KHQ is a 21 item questionnaire, consisting of 9 domains: General health (GH) (1\[Very good\] to 5\[Very poor\]), Incontinence impact (Int Imp) (1\[Not at all\] to 4\[A lot\]), Role Limitations (RL) (1\[Not at all\] to 4\[A lot\]), Physical limitations (PL) (1\[Not at all\] to 4\[A lot\]), Social limitations (SL) (0\[not applicable\] to 4\[A lot\]), Personal relationships (PR) (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), Sleep/ energy (S/ E) (1\[Never\] to 4\[All the time\]) and Severity/Coping (S/ C) (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value,including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores
KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1\[Very good\] to 5\[Very poor\]), Int Imp (1\[Not at all\] to 4\[A lot\]), RL (1\[Not at all\] to 4\[A lot\]), PL (1\[Not at all\] to 4\[A lot\]), SL (0\[not applicable\] to 4\[A lot\]), PR (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), S/ E (1\[Never\] to 4\[All the time\]) and S/ C (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12, Week 24 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores
KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1\[Very good\] to 5\[Very poor\]), Int Imp (1\[Not at all\] to 4\[A lot\]), RL (1\[Not at all\] to 4\[A lot\]), PL (1\[Not at all\] to 4\[A lot\]), SL (0\[not applicable\] to 4\[A lot\]), PR (0\[Not applicable\] to 4\[A lot\]), Emotions (1\[Not at all\] to 4\[Very much\]), S/ E (1\[Never\] to 4\[All the time\]) and S/ C (1\[Never\] to 4\[All the time\]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)
Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').
Time frame: Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS
Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').
Time frame: Week 0, Week 2, Week 6, Week 12, Week 24 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS
Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').
Time frame: Week 0, Week 2, Week 6, Week 12 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score
Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score
Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12, Week 24 and Week 36 in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score
Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (\<=7 times) to 1 (\>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (\>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12 and Week 24 in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.
Time frame: Up to 48 weeks in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 1 comprised of all participants who received at least one dose of GSK1358820.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 2 comprised of all participants who received at least two doses of GSK1358820.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 3 comprised of all participants who received at least three doses of GSK1358820.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U
Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U
Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U
Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U
Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate
Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1) and Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U
Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U
Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U
Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U
Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature
Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U
Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U
Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U
Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U
Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results
Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alkaline Phosphatase (Alk Phosp), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin (Bil), Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, Total Protein (T Protein), Urea/blood urea nitrogen (BUN) and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results
Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results
Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters
Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils (Eosino), Hemoglobin (Hb), Hematocrit (Hct), Lymphocytes (Lympho), Monocytes, Neutrophil Bands (N bands), Total Neutrophils (T neutro), Platelet count (PC), Red Blood Cell (RBC) count, and White Blood Cell count (WBC). Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters
Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters
Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose on Day 1) and up to 48 weeks in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline
Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Urinary Tract Infection (UTI)
A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 Colony Forming Unit per milliliter (CFU/mL) and leukocyturia with \>5 per high power field was noted.
Time frame: Up to 48 weeks in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 100 U
A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U
A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 100 U
A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U
A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with \>=10\^5 CFU/mL and leukocyturia with \>5 per high power field was noted.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume
PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U
PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U
PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U
PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U
PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.
Time frame: Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
Treatment Phase 1 (Treatment Cycle 1): Number of Participants Using Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR
Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Time frame: Up to 48 weeks in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U
Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U
Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U
Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U
Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound
The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Time frame: Up to 48 weeks in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U
The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U
The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U
The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U
The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.
Time frame: Up to 48 weeks after 1st treatment
Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QT interval corrected for heart rate (QTc) value is machine-read or manually over-read. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Baseline (Pre-dose on Day 1), Week 12 and Week 48 in Treatment Cycle 1
Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings
Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2
Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings
Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3
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GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Fukuoka, Japan
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