Phase 2
Completed N=951
Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
Source: ClinicalTrials.gov NCT00561951 ↗Enrolled (actual)
951
Serious AEs
0.8%
Results posted
Sep 2010
Primary outcomePrimary: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. — -1.01; -1.35; -1.40 UUI Episodes — p=0.002
Summary
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. |
-1.01; -1.35; -1.40 | 0.002 sig |
| SECONDARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. |
-0.79; -1.10; -1.12; -1.15; -1.48; -1.49 | — |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. |
-0.59; -1.15; -1.25 | 0.002 sig |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. |
-0.47; -0.94; -1.06; -0.85; -1.33; -1.60 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12. |
-1.00; -1.65; -1.66 | 0.003 sig |
| SECONDARY Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. |
-0.79; -1.37; -1.59; -1.60; -2.16; -2.16 | — |
| SECONDARY Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12. |
-0.88; -1.27; -1.15 | 0.002 sig |
| SECONDARY Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12. |
-0.80; -1.11; -1.06; -1.22; -1.61; -1.50 | — |
| SECONDARY Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12. |
-0.18; -0.21; -0.29 | 0.624 |
| SECONDARY Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12. |
-0.25; -0.24; -0.34; -0.30; -0.30; -0.46 | — |
| SECONDARY Change From Baseline in Mean Voided Volume Per Micturition at Week 12. |
13.07; 22.80; 32.77 | — |
| SECONDARY Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12. |
5.06; 13.63; 21.52; 9.23; 21.62; 27.41 | — |
| SECONDARY Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ). |
-7.02; -9.36; -6.10; -22.46; -27.33; -25.09 | — |
| SECONDARY Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12. |
-18.25; -26.61; -26.35; 12.88; 17.84; 17.29 | — |
| SECONDARY Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12. |
-1.57; -1.83; -1.76 | — |
| SECONDARY 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. |
82; 97; 83; 28; 12; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00561951). 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. Informational only — not medical advice.