Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder

Phase 3

Terminated

• Conditions: Overactive Bladder
• Interventions: Drug: Vesicare (solifenacin); Behavioral: Vesicare (solifenacin) plus behavioral modification

• Registration Number: NCT00821184
• Lead Sponsor: Lahey Clinic

Brief Summary

This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Detailed Description

Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Results First Submitted: 2009-12-04
• Results First Submitted QC: 2010-07-29
• Results First Posted: 2010-07-30
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Female patients > 18 years of age
• OAB symptoms for > 3 months
• Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence.
• May or may not be accompanied by urinary frequency
• May be accompanied by stress urinary incontinence where stress incontinence does not predominate

Exclusion Criteria

• Male Patients
• Underlying cortical or spinal cord pathology including SCI, MS, or
• Parkinson's Disease
• Urinary retention with post-void residual > 150cc
• Current treatment or treatment within the last 3 months with anticholinergic medications
• Patients not able to complete the questionaires or voiding diaries in English
• Pregnancy
• Active urinary tract infections
• Bladder Cancer or unevaluated hematuria
• Known diagnosis of narrow angle glaucoma
• Severe constipation
• History of reduced renal function (CrCl<30ml/min)
• History of liver disease
• Current treatment with cytochrome P450 inhibitor medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vesicare	Vesicare (solifenacin)	Vesicare alone
Vesicare/behavioral modification	Vesicare (solifenacin) plus behavioral modification	Vesicare plus behavioral modification

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.	0 week - 12 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement of Symptom Severity	3 months

Trial Locations

Locations (1)

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States