Title
Overactive Bladder Innovative Therapy Trial (OrBIT)
Overactive Bladder Innovative Therapy Trial
Phase
Phase 4Lead Sponsor
Uroplasty, IncStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Overactive BladderIntervention/Treatment
tolterodine ...Study Participants
100The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).
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).
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
| Event Type | Organ System | Event Term | Urgent PC Treatment Arm | 4mg Daily Tolterodine |
|---|
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.
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
