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NCT01276340 Clinical Trial

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

Urinary Incontinence Clinical Trial

Official title:
Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01276340
Other study ID # 1008433
Secondary ID
Status Completed
Phase N/A
First received January 11, 2011
Last updated May 16, 2012
Start date September 2010
Est. completion date February 2012

Study information
Verified date May 2012
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority France: Institutional Ethical Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date February 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CHU de Clermont-Ferrand Clermont-Ferrand
France CHU Dijon Dijon
France CHU Grenoble Grenoble
France CH Issoire Issoire
France CHU Limoges Limoges
France Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary change of quality of life after electrostimulation Change from baseline in quality of life after 2 months of electrostimulation Measurement of health-related quality of life with "contilife" questionnaire 2 months No
Secondary change of urinary handicap after electrostimulation Change from baseline in urinary handicap after 2 months of electr-st-imulation. Measurement of urinary handicap with "MHU" questionnaire 2 months No
Secondary satisfaction after electrostimulation description of patient's satifaction 2 months after electrostimulation by satisfaction questionaire 2 months No
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