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

NCT ID: NCT01276340

Last Updated: 2012-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

women with urinary incontinence

KEAT stimulator

Intervention Type DEVICE

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

Interventions

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KEAT stimulator

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gautier CHENE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CHU Dijon

Dijon, , France

Site Status

CHU Grenoble

Grenoble, , France

Site Status

CH Issoire

Issoire, , France

Site Status

CHU Limoges

Limoges, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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1008433

Identifier Type: -

Identifier Source: org_study_id

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