Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)

Overactive Bladder Clinical Trial

Official title: Pilot Clinical Trial to Study the Effectiveness of a Four-week Exposure to a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence in Subjects With Idiopathic Overactive Bladder (OAB)

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.

Clinical Trial Description

While the precise cause of OAB symptoms (urge, frequency, incontinence) is not clear, most physicians and researchers accept the theory that a problem in the communication between the central nervous system and the bladder is a factor.

Research has shown that a process called neuromodulation of the nerves controlling the bladder can overcome this communication problem. In patients who have symptoms caused by the communication problem, neuromodulation has been clinically proven to eliminate or significantly reduce those symptoms. While neuromodulation has been previously achieved by implanting an electrode near the sacral nerve in the spine, the new concept under investigation within this protocol is believed to achieve a similar effect from adhesive electrodes placed on the skin over spinal nerves in the lower back. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

• NCT number: NCT01125722
• Study type: Interventional
• Source: Ethicon Endo-Surgery
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Completion date: March 2011