Phase 3
Completed N=304
Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
Source: ClinicalTrials.gov NCT00658684 ↗Enrolled (actual)
304
Serious AEs
0.7%
Results posted
Aug 2010
Primary outcomePrimary: Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume — 138; 91; 25; 22 Number of subjects
Summary
To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume |
138; 91; 25; 22; 102; 61 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52 |
1.6; 1.4; 1.7; 2.1; -0.86; -0.99 | — |
| SECONDARY Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52 |
11.3; 11.0; 11.2; 12.3; -1.42; -1.73 | — |
| SECONDARY Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52 |
4.5; 3.9; 6.2; 5.1; -1.69; -1.77 | — |
| SECONDARY Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52 |
1.8; 1.6; 1.8; 2.5; -0.84; -0.99 | — |
| SECONDARY Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52 |
1.4; 1.2; 1.6; 1.6; -0.31; -0.34 | — |
| SECONDARY Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52 |
158.1; 162.8; 156.1; 143.6; 16.67; 20.58 | — |
| SECONDARY Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52 |
37.5; 37.1; 37.0; 39.3; -2.19; -0.57 | — |
| SECONDARY Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52 |
42.7; 37.4; 45.2; 58.7; -25.13; -22.30 | — |
| SECONDARY The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage |
115; 75; 21; 19; 116; 75 | — |
| SECONDARY Change From Baseline in Grade of PPBC at Week 28 and 52 |
4.3; 4.2; 4.5; 4.4; -1.66; -1.74 | — |
Eligibility Criteria
Inclusion Criteria
- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urinary urgency episodes >=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 (NCT00658684). 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.