This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
896
4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
Matched placebo tablets once daily for 12 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.
Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline
Time frame: Baseline and Week 12
Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline
The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at observation minus mean at baseline
Time frame: Baseline, Week 2 and Week 6
Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline
Change in number of urgency episodes (urinary sensation scale \[USS\] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline
Change in number of severe urgency episodes (urinary sensation scale \[USS\] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline
Change in number of UUI episodes (urinary sensation scale \[USS\] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine
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Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline
Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline
Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline
Change in frequency urgency sum is total urinary sensation scale (USS) ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold:leak urine. Numerical decrease indicates improvement
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale
Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement. Change: mean at Week 12 minus mean at baseline
Time frame: Baseline and Week 12
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales
Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement. Change: mean at Week 12 minus mean at baseline.
Time frame: Baseline and Week 12
Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline
PPBC scale range: 1='does not cause me any problems at all' to 6='causes me many severe problems'. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline
Time frame: Baseline, Week 2, Week 6 and Week 12
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline
UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet \[without leaking\]"). Improvement: positive score change; No change: score change=0; Deterioration: negative score change
Time frame: Baseline, Week 2, Week 6 and Week 12
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline
The urgency severity VAS Scale records the subject's assessment of the severity of urgency. VAS scale ranges from 1 'Very Mild' to 10 'Very Severe'. Negative change indicated improvement. Change: mean at observation minus mean at baseline.
Time frame: Baseline, Week 2, Week 6 and Week 12