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A Pilot Study to Evaluate Safety and Performance of Neuromuscular Electrical Stimulation With the Inko RS Device for the Treatment of Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:
A Pilot Study to Evaluate the Safety and Performance of Neuromuscular Electrical Stimulation (NMES) With the Inko RS Device for the Treatment of Stress Urinary Incontinence

Clinical Trial Summary

This is a pilot clinical study taking place at one site in Berlin, Germany using Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20 women suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days out of 7 set treatment program with the device. After the 12 week treatment programme the subjects will be asked to perform daily set exercises for a further 14 weeks.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01472068
Study type Interventional
Source Bio-Medical Research, Ltd.
Contact
Status Completed
Phase Phase 1
Start date December 2011
Completion date October 2012
View Details
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