Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2006-06-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Urgent PC treatment arm
Urgent PC Neuromodulation System
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Tolterodine
Interventions
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Urgent PC Neuromodulation System
The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
Tolterodine
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Uroplasty, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Megan O'Toole
Role: STUDY_DIRECTOR
Uroplasty, Inc
Locations
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Uroplasty, Inc
Minnetonka, Minnesota, United States
Countries
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Other Identifiers
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UPC032006
Identifier Type: -
Identifier Source: org_study_id
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