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

Information source: Lahey Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: Vesicare (solifenacin) (Drug); Vesicare (solifenacin) plus behavioral modification (Behavioral)

Phase: Phase 3

Status: Terminated

Sponsored by: Lahey Clinic

Official(s) and/or principal investigator(s):
John T Stoffel, M.D., Principal Investigator, Affiliation: Lahey Clinic


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Improvement of Symptom Severity

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.


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


- 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 and Contacts

Lahey Clinic, Burlington, Massachusetts 01805, United States
Additional Information

Starting date: September 2006
Last updated: July 29, 2010

Page last updated: August 23, 2015

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