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

Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01276340
Enrollment
450
Registered
2011-01-13
Start date
2010-09-30
Completion date
2012-02-29
Last updated
2012-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence, Urinary stress incontinence, Urinary urge incontinence, Women, electrical stimulation, KEAT stimulator, quality of life

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.

Interventions

DEVICEKEAT stimulator

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change of quality of life after electrostimulation2 monthsChange from baseline in quality of life after 2 months of electrostimulation Measurement of health-related quality of life with contilife questionnaire

Secondary

MeasureTime frameDescription
change of urinary handicap after electrostimulation2 monthsChange from baseline in urinary handicap after 2 months of electr-st-imulation. Measurement of urinary handicap with MHU questionnaire
satisfaction after electrostimulation2 monthsdescription of patient's satifaction 2 months after electrostimulation by satisfaction questionaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026