Fesoterodine Flexible Dose Study
- Registration Number
- NCT00536484
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 896
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (Double-Blind) Placebo - Fesoterodine (Double-Blind) Fesoterodine -
- Primary Outcome Measures
Name Time Method Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. Baseline and Week 12 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
- Secondary Outcome Measures
Name Time Method Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline Baseline, Week 2 and Week 6 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 baselineChange in Number of Urgency Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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.
Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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.
Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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
Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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.
Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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
Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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
Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale Baseline and Week 12 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 baselineChange in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales Baseline and Week 12 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.Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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
Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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
Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline Baseline, Week 2, Week 6 and Week 12 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Spokane, Washington, United States
Pfizer Investigational Site🇺🇸Spokane, Washington, United States