Overactive Bladder Innovative Therapy Trial (OrBIT)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uroplasty, Inc
• Treatments: Tolterodine Tartrate

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