Phase 4
N=990
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Urinary Bladder, Overactive
Bottom Line
View on ClinicalTrials.gov: NCT01302054 ↗Enrolled (actual)
990
Serious AEs
0.9%
Results posted
Mar 2013
Primary outcome: Primary: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours — 3.93; 1.60 episodes per 24 hours — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fesoterodine 8 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours |
3.93; 1.60 | <0.0001 sig |
| PRIMARY Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 |
3.93; 3.83; -2.32; -1.76 | 0.0079 sig |
| SECONDARY Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 |
12.44; 12.48; -1.94; -1.57 | 0.0931 |
| SECONDARY Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12 |
11.38; 11.26; -3.33; -2.52 | 0.0438 sig |
| SECONDARY Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12 |
0; 0; 4; 6; 15; 9 | <0.0001 sig |
| SECONDARY Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12 |
126; 99; 158; 157; 7; 11 | 0.0095 sig |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12 |
66.67; 64.74; -24.61; -15.99 | 0.0001 sig |
| SECONDARY Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12 |
43.63; 44.25; 23.11; 13.83; 38.74; 41.15 | <0.0001 sig |
| SECONDARY Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2 |
72.8; 59.6 | 0.0023 sig |
| SECONDARY Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline |
69.9; 57.0 | 0.0027 sig |
| SECONDARY Percentage of Participants With No UUI Episodes (Diary Dry Rate) |
25.4; 17.7; 39.0; 32.3 | 0.0427 sig |
Summary
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of overactive bladder with symptoms for at least 6 months.
- Moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine
- Women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception
Exclusion Criteria
- Conditions or prior treatment that may also affect bladder function
- Clinically significant urinary tract infection (UTI)
- Ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).
Data sourced from ClinicalTrials.gov (NCT01302054). 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.