NCT01472068

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Bio-Medical Research, Ltd. · Industry
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Inko RS Device	30 minute pre-programmed treatment for 5 days out of 7. Treatment to be carried out while standing.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-08-01
• Completion: 2012-10-01
• First posted: 2011-11-16
• Last updated: 2016-02-03

Locations

1 site across 1 country: Germany