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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
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 and Contacts
Lahey Clinic, Burlington, Massachusetts 01805, United States
Additional Information
Starting date: September 2006
Last updated: July 29, 2010
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