Phase 3
N=883
Fesoterodine Flexible Dose Study
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT00536484 ↗Enrolled (actual)
883
Serious AEs
—
Results posted
Sep 2009
Primary outcome: Primary: Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. — -2.1; -2.9 number of episodes per 24 hours — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fesoterodine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. |
-2.1; -2.9 | 0.0002 sig |
| SECONDARY Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline |
-1.3; -1.8; -2.0; -2.7 | 0.0136 sig |
| SECONDARY Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline |
-1.9; -2.3; -2.9; -3.5; -3.0; -4.0 | 0.1057 |
| SECONDARY Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline |
-1.6; -1.8; -2.2; -2.6; -2.2; -2.9 | 0.1666 |
| SECONDARY Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline |
-0.9; -1.1; -1.2; -1.5; -1.2; -1.5 | 0.2054 |
| SECONDARY Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline |
-0.5; -0.5; -0.7; -0.7; -0.7; -0.8 | 0.8019 |
| SECONDARY Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline |
-0.6; -0.6; -0.8; -0.9; -0.9; -1.0 | 0.8279 |
| SECONDARY Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline |
-6.5; -8.3; -9.8; -12.5; -10.3; -13.6 | 0.0203 sig |
| SECONDARY Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale |
-20.0; -27.8 | <0.0001 sig |
| SECONDARY Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales |
20.9; 29.3; 20.2; 27.2; 21.2; 25.9 | <0.0001 sig |
| SECONDARY Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline |
13.2; 16.6; 34.8; 39.4; 45.2; 39.4 | 0.0087 sig |
| SECONDARY Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline |
22.9; 29.3; 69.2; 64.5; 7.9; 6.2 | 0.0129 sig |
| SECONDARY Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline |
-0.8; -1.4; -1.4; -2.2; -1.4; -2.4 | <0.0001 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00536484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.