Phase 4
Completed N=127
Trospium Chloride XR in Obese Female Patients With Overactive Bladder
Obesity · Overactive Bladder · Incontinence
Source: ClinicalTrials.gov NCT00932022 ↗
Enrolled (actual)
127
Serious AEs
0.8%
Results posted
Jan 2013
Primary outcomePrimary: Percent Change From Baseline in Urinary Urgency Incontinence (UUI) — -23.7; 57.8 Percent change
Summary
This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Urinary Urgency Incontinence (UUI) |
-23.7; 57.8 | — |
| SECONDARY Percent Change From Baseline in Urgency Severity Associated With Toilet Voids |
— | — |
| SECONDARY Percent Change From Baseline in Voided Volume |
— | — |
| SECONDARY Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score |
— | — |
| SECONDARY Percent Change From Baseline in Percentage of Patients Continent |
— | — |
Eligibility Criteria
Inclusion Criteria
- OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
- Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
- Obese
Exclusion Criteria
- Chronic kidney failure
- Abdominal bypass surgery for obesity
- Moderate or severe memory impairment
- Uncontrolled narrow angle glaucoma
- Uncontrolled systemic disease
- Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia
Data sourced from ClinicalTrials.gov (NCT00932022). 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.