Phase 2
N=22
Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01042236 ↗Enrolled (actual)
22
Serious AEs
1.6%
Results posted
Jul 2011
Primary outcome: Primary: Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 — 49.86; 49.86; 49.86; 47.92 centimeter of water (cmH2O) — p=0.4907
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fesoterodine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 |
49.86; 49.86; 49.86; 47.92; 49.16; 48.53 | 0.4907 |
| SECONDARY Change From Baseline in Closing Urethral Pressure at Day 7 |
40.62; 40.62; 40.62; 37.84; 38.75; 38.66 | 0.9870 |
| SECONDARY Change From Baseline in Opening Urethral Elastance at Day 7 |
1.93; 1.93; 1.93; 1.66; 1.85; 1.83 | 0.9403 |
| SECONDARY Change From Baseline in Closing Urethral Elastance at Day 7 |
1.85; 1.85; 1.85; 1.56; 1.74; 1.75 | 0.8602 |
| SECONDARY Incontinence Episode Frequency Per 24 Hours |
1.52; 1.52; 1.52; 0.71; 0.98; 0.82 | — |
| SECONDARY Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours |
-66.67; -55.56; -60.00 | — |
| SECONDARY Stress Incontinence Episode Frequency Per 24 Hours |
1.44; 1.44; 1.44; 0.69; 0.98; 0.82 | — |
| SECONDARY Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours |
-66.67; -55.56; -60.00 | — |
| SECONDARY Urgency Urinary Incontinence Episode Frequency Per 24 Hours |
0.08; 0.08; 0.08; 0.02; 0.00; 0.00 | — |
| SECONDARY Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours |
-50.00; -100.00; -100.00 | — |
| SECONDARY Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration |
2.303; 4.902; 2.185; 4.971 | — |
Summary
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
Eligibility Criteria
Inclusion Criteria
- Female, 18 - 65 years
- SUI symptoms for longer than 3 months
- Subjects must be non-pregnant and not breastfeeding
Exclusion Criteria
- Disease or medical condition affecting the bladder or urinary tract (other tan stress urinary incontinence)
- Subjects taking medication with effects on the bladder or urinary tract
- Subejcts with medical conditions which could be adversely affected by administration of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment
Data sourced from ClinicalTrials.gov (NCT01042236). 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.