Overactive Bladder Innovative Therapy Trial (OrBIT)

Uroplasty

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Tolterodine; Device: Urgent PC Neuromodulation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448175

UPC032006

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Urgent PC treatment arm

Experimental group

Treatment:

Drug: Tolterodine

Device: Urgent PC Neuromodulation System