Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: KEAT stimulator

• Registration Number: NCT01276340
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The investigators performed a prospective analysis of 450 women with stress, urge and mixed incontinence in order to assess the health-related quality of life (Contilife® questionnaire) and the objective cure rate after two months of electrical stimulation (Keat® stimulator). Management of urinary incontinence with the Keat® stimulator could given an improvement in the quality of life and a good rate of satisfaction without side effect.

Objective cure is as good as subjective improvement especially in urinary stress incontinence. Keat® stimulator is a non-invasive and simple new technique that could be the bew first-line non surgical treatment for female urinary incontinence.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• women
• age > 18 years
• stress, urge or mixed incontinence with indication of perineal reeducation
• follow in gynecology

Exclusion Criteria

• incontinence due to neurological disorders
• younger than 18 years old
• pregnancy
• patient with pace-maker
• patient with gynecological cancer
• patient who don't understand the electrical stimulation procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	KEAT stimulator	women with urinary incontinence

Primary Outcome Measures

Name	Time	Method
change of quality of life after electrostimulation	2 months	Change from baseline in quality of life after 2 months of electrostimulation Measurement of health-related quality of life with "contilife" questionnaire

Secondary Outcome Measures

Name	Time	Method
change of urinary handicap after electrostimulation	2 months	Change from baseline in urinary handicap after 2 months of electr-st-imulation. Measurement of urinary handicap with "MHU" questionnaire
satisfaction after electrostimulation	2 months	description of patient's satifaction 2 months after electrostimulation by satisfaction questionaire

Trial Locations

Locations (6)

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Limoges; 🇫🇷 Limoges, France

CH Issoire; 🇫🇷 Issoire, France