Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
- Registration Number
- NCT00561951
- Lead Sponsor
- Pfizer
- Brief Summary
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 951
- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day.
- Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
- Patient has a known neurological disease influencing bladder function.
- Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fesoterodine fumarate 4 mg (Double-Blind) fesoterodine fumarate - Placebo (Double-Blind) Placebo - Fesoterodine fumarate 8 mg (Double-Blind) fesoterodine fumarate -
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. Baseline to Week 12 Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at Week 12 minus mean at Baseline.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. Baseline to Weeks 2, 4, 8, and 12 Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at each visit minus mean at Baseline.Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. Baseline to Week 12 Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at Week 12 minus mean at Baseline.Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. Baseline to Weeks 2, 4, 8, and 12 Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. Baseline to Week 12 Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at Week 12 minus mean at Baseline.Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. Baseline to Weeks 2, 4, 8, and 12 Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at each visit minus mean at Baseline.Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. Baseline to Week 12 Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Incontinence is the complaint of any involuntary leakage of urine.
Change: mean at Week 12 minus mean at Baseline.Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. Baseline to Weeks 2, 4, 8, and 12 Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Incontinence is the complaint of any involuntary leakage of urine.
Change: mean at each visit minus mean at Baseline.Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. Baseline to Week 12 Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at Week 12 minus mean at Baseline.Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. Baseline to Weeks 2, 4, 8, and 12 Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.Change From Baseline in Mean Voided Volume Per Micturition at Week 12. Baseline to Week 12 Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.
Change: mean at Week 12 minus mean at Baseline.Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. Baseline to Weeks 2, 4, 8, and 12 Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). Baseline to Week12 King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.
Change: mean at Week 12 minus mean at Baseline.Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. Baseline to Week 12 The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).
The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.
Change: mean at Week 12 minus mean at Baseline.Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. Baseline to Week 12 Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
1. No problems at all
2. Some very minor problems
3. Some minor problems
4. Some moderate problems
5. Severe problems
6. Many severe problems
Change: mean at Week 12 minus mean at Baseline.The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12. Baseline to Week 12 Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
1. No problems at all
2. Some very minor problems
3. Some minor problems
4. Some moderate problems
5. Severe problems
6. Many severe problems
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Taipei, Taiwan