Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932022
• Other study ID #: MA-SXR-09-003
• Secondary ID: Sanctura XR obes
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2009
• Last updated: December 14, 2012
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incontinence
• Obesity
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Trospium Chloride, Extended Release (XR)
Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.

Other:
• placebo
Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No