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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence, Stress Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KEAT stimulator

Device

electrical stimulation with KEAT stimulator : 4 times per week during 2 months

Primary outcomes

change of quality of life after electrostimulation

Time frame: 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 outcomes

change of urinary handicap after electrostimulation

Time frame: 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

Time frame: 2 months

description of patient's satifaction 2 months after electrostimulation by satisfaction questionaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Jan 13, 2011
Registry last updated: May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed