Fesoterodine Flexible Dose Study

Study Overview
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Brief Summary
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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.

Official Title
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A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Fesoterodine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overactive bladder symptoms for greater than or equal to 3 months. Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary. Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary. Exclusion Criteria: Contraindication to fesoterodine (antimuscarinics). Known etiology of OAB (e.g., neurogenic, local urinary tract pathology). Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline. Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fesoterodine (Double-Blind)<br> | Drug: Fesoterodine<br>* 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.<br>|
| Placebo Comparator: Placebo (Double-Blind)<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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 | 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. | 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 | 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 | 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 | 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. | 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 | 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 | 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. | Baseline, Week 2, Week 6 and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder