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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Trial of Behavioral Modification and Solifenacin (Vesicare)vs Solifenacin (Vesicare) Alone for the Treatment of Urge Incontinence in Patients With an Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Vesicare (solifenacin)
* Behavioral: Vesicare (solifenacin) plus behavioral modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vesicare<br>Vesicare alone | Drug: Vesicare (solifenacin)<br>* 5mg po qd<br>|
| Active Comparator: Vesicare/behavioral modification<br>Vesicare plus behavioral modification | Behavioral: Vesicare (solifenacin) plus behavioral modification<br>* 5 mg dose po once daily plus behavioral modification<br>* Other names: Vesicare (solifenacin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries. |  | 0 week - 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Symptom Severity |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, overactive bladder, urinary frequency