Status:
COMPLETED
Overactive Bladder Innovative Therapy Trial (OrBIT)
Lead Sponsor:
Uroplasty, Inc
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).
Eligibility Criteria
Inclusion
- Is at least 18 years of age
- Experiences OAB with a voiding frequency of at least 8 times per day
- Is ambulatory and able to use a toilet independently and without difficulty
Exclusion
- On OAB pharmacotherapy within the previous month
- Primary complaint is stress urinary incontinence
- Has pacemaker or implantable defibrillator
- Has history of heart problems
- Has nerve damage or neuropathy
- Has gastric or urinary retention
- Has uncontrolled narrow-angle glaucoma
- Has known sensitivity to drug ingredients
- Is pregnant or planning to become pregnant during the trial
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00448175
Start Date
June 1 2006
End Date
October 1 2008
Last Update
May 16 2013
Active Locations (1)
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1
Uroplasty, Inc
Minnetonka, Minnesota, United States, 55343