NCT01369485

Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder

Multi-center, Prospective, Randomized, Double-blind, Sham-controlled Clinical Study to Evaluate Safety and Effectiveness of a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Subjects With Overactive Bladder (OAB)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Ethicon Endo-Surgery · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the change from baseline between the active and sham treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	(VERV™ System)	Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
DEVICE	Sham version of (VERV™ System)	Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-01-01
• Completion: 2013-12-01
• First posted: 2011-06-09
• Last updated: 2014-09-11
• Results posted: 2014-09-11

Locations

14 sites across 1 country: United States