Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Study Overview
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Brief Summary
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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.

Conditions
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Obesity, Overactive Bladder, Incontinence

Intervention / Treatment
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* Drug: Trospium Chloride, Extended Release (XR)
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trospium chloride XR 60 mg<br>Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks. | Drug: Trospium Chloride, Extended Release (XR)<br>* Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.<br>* Other names: Sanctura XR™ 60 mg;Other: placebo<br>* Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.<br>|
| Placebo Comparator: placebo<br>Placebo capsule taken orally once daily for 14 weeks. | Other: placebo<br>* Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Urinary Urgency Incontinence (UUI) | Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement. | Baseline (Week 2), Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Urgency Severity Associated With Toilet Voids | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Baseline (Week 2), Week 14 | 
| Percent Change From Baseline in Voided Volume | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Baseline (Week 2), Week 14 | 
| Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Baseline (Week 2), Week 14 | 
| Percent Change From Baseline in Percentage of Patients Continent | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Baseline (Week 2), Week 14 |