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

May 16, 2012 updated by: Centre Hospitalier Universitaire de Saint Etienne

Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand
      • Dijon, France, 21000
        • CHU Dijon
      • Grenoble, France, 38000
        • CHU Grenoble
      • Issoire, France, 63500
        • Ch Issoire
      • Limoges, France, 87042
        • CHU Limoges
      • Lyon, France, 69000
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women with stress, urge and mixed incontinence with an indication for perineal reeducation follow in gynecology

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
women with urinary incontinence
Device: KEAT stimulator
electrical stimulation with KEAT stimulator : 4 times per week during 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months
satisfaction after electrostimulation
Time Frame: 2 months
description of patient's satifaction 2 months after electrostimulation by satisfaction questionaire
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Gautier CHENE, MD, Chu de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimate)

January 13, 2011

Study Record Updates

Last Update Posted (Estimate)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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