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

Phase 3TerminatedNCT00821184

Lahey Clinic12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overactive Bladder

Interventions

Vesicare (solifenacin)DRUG

5mg po qd

Vesicare (solifenacin) plus behavioral modificationBEHAVIORAL

5 mg dose po once daily plus behavioral modification

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Lahey Clinic

Burlington, Massachusetts, United States

Outcomes

Primary Outcomes

Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.

Time frame: 0 week - 12 weeks

Secondary Outcomes

Improvement of Symptom Severity

Time frame: 3 months

Data from ClinicalTrials.gov

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