To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
516
12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.
Mean Number of Micturition Episodes Per 24 Hours
The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Time frame: Baseline and Week 12
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Time frame: Baseline and Week 12
Mean Number of Urgency Episodes Per 24 Hours
The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Time frame: Baseline and Week 12
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
Time frame: Week 12
Nocturnal Micturitions Per 24 Hours
Nocturnal micturitions (synonymous with the term "nighttime micturitions") were those recorded in the bedtime section of the bladder diary.
Time frame: Baseline and Week 12
Severe Urgency Episodes Per 24 Hours
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Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.
Time frame: Baseline and Week 12
Mean Rating on the Urinary Sensation Scale
The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."
Time frame: Baseline and Week 12
Patient Perception of Bladder Condition (PPBC) Score
The PPBC score ranges from 1 "no problems at all" to 6 "many severe problems."
Time frame: Baseline and Week 12
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
Improvement: negative score change; No change: score change=0; Deterioration: positive score change
Time frame: Baseline and Week 12
Urgency Perception Scale (UPS)
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 \[without leaking\]").
Time frame: Baseline and Week 12
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
Improvement: positive score change; No improvement: zero or negative score change
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - 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, higher scores represent less favorable outcome.
Time frame: Baseline and Week 12
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically \& results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.
Time frame: Week 12
Sum Rating on the Urinary Sensation Scale
The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."
Time frame: Baseline and Week 12
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.
Time frame: Week 12