NCT00448175
Completed
Phase 4
Overactive Bladder Innovative Therapy Trial
ConditionsOveractive Bladder
DrugsTolterodine
Overview
- Phase
- Phase 4
- Intervention
- Urgent PC Neuromodulation System
- Conditions
- Overactive Bladder
- Sponsor
- Uroplasty, Inc
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Frequency of Voids at 12 Weeks
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Urgent PC treatment arm
Intervention: Urgent PC Neuromodulation System
Urgent PC treatment arm
Intervention: Tolterodine
Outcomes
Primary Outcomes
Frequency of Voids at 12 Weeks
Time Frame: Baseline to 12 weeks
To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries.
Secondary Outcomes
- Urge Incontinence Episodes at 12 Weeks(12 weeks)
- Volume Voided at 12 Weeks(12 weeks)
- OAB Quality of Life at 12 Weeks(12 weeks)
- Known Side Effects Through 12 Weeks(12 weeks)
Study Sites (1)
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