Status:
TERMINATED
Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
Lead Sponsor:
Lahey Clinic
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
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 Vesicar...
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 behav...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00821184
Start Date
September 1 2006
End Date
September 1 2008
Last Update
April 4 2018
Active Locations (1)
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1
Lahey Clinic
Burlington, Massachusetts, United States, 01805