Overactive Bladder Innovative Therapy Trial (OrBIT)

Phase 4

Completed

• Conditions: Overactive Bladder
• Interventions: Device: Urgent PC Neuromodulation System; Drug: Tolterodine

• Registration Number: NCT00448175
• Lead Sponsor: Uroplasty, Inc

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-16
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2013-01-24
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-04
• Last Update Submitted: 2013-04-04
• Results First Posted: 2013-05-16
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urgent PC treatment arm	Urgent PC Neuromodulation System	-
Urgent PC treatment arm	Tolterodine	-

Primary Outcome Measures

Name	Time	Method
Frequency of Voids at 12 Weeks	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Uroplasty, Inc; 🇺🇸 Minnetonka, Minnesota, United States