Phase 4
Completed N=331
UK Study Assessing Flexible Dose Fesoterodine in Adults
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT00806494 ↗
Enrolled (actual)
331
Serious AEs
3.3%
Results posted
Jan 2011
Primary outcomePrimary: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 — -3.26 Number of Episodes
Summary
To explore the effects of fesoterodine when used in a flexible dose manner
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 |
-3.26 | — |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 |
-2.55 | — |
| SECONDARY Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12 |
-18.69; -23.61 | — |
| SECONDARY Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 |
-0.61; -0.78 | — |
| SECONDARY Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 |
-15.18; -23.35 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12 |
-1.19; -1.64 | — |
| SECONDARY Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12 |
-59.11; -79.30 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12 |
-3.94; -5.10 | — |
| SECONDARY Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12 |
-40.69; -51.75 | — |
| SECONDARY Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12 |
-0.95; -1.16 | — |
| SECONDARY Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12 |
-38.71; -44.78 | — |
| SECONDARY Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12 |
-2.31; -2.93 | — |
| SECONDARY Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12 |
-57.37; -69.14 | — |
| SECONDARY Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12 |
-0.49; -0.64 | — |
| SECONDARY Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 |
86; 121; 93; 7; 160; 94 | — |
| SECONDARY Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 |
105; 189; 13; 154; 159; 8 | — |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12 |
-27.95; -37.25 | — |
| SECONDARY Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12 |
-5.13 | — |
| SECONDARY Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire |
188; 82; 36; 253; 54; 184 | — |
| SECONDARY Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12 |
73.6 | — |
| SECONDARY Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 |
-2.57; -29.69; -41.16; -36.60; -25.22; -15.23 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female >18 years old
- OAB for >3 months
Exclusion Criteria
- Patients with conditions that would contraindicate for fesoterodine use
- Patients with significant hepatic and renal disease or other significant unstable diseases.
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Data sourced from ClinicalTrials.gov (NCT00806494). 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.