Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Phase 4

Completed

• Conditions: Obesity; Overactive Bladder; Incontinence
• Interventions: Drug: Trospium Chloride, Extended Release (XR); Other: placebo

• Registration Number: NCT00932022
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-02
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-12
• Results First Submitted: 2012-12-14
• Results First Submitted QC: 2012-12-14
• Last Update Submitted: 2012-12-14
• Results First Posted: 2013-01-21
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trospium chloride XR 60 mg	Trospium Chloride, Extended Release (XR)	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.
trospium chloride XR 60 mg	placebo	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.
placebo	placebo	Placebo capsule taken orally once daily for 14 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Urinary Urgency Incontinence (UUI)	Baseline (Week 2), Week 14	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.

Secondary Outcome Measures

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