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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01276340
First received: January 11, 2011
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Urinary Incontinence
Device: KEAT stimulator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • change of quality of life after electrostimulation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Change from baseline in quality of life after 2 months of electrostimulation Measurement of health-related quality of life with "contilife" questionnaire


Secondary Outcome Measures:
  • change of urinary handicap after electrostimulation [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    description of patient's satifaction 2 months after electrostimulation by satisfaction questionaire


Enrollment: 450
Study Start Date: September 2010
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
women with urinary incontinence
Device: KEAT stimulator
electrical stimulation with KEAT stimulator : 4 times per week during 2 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276340

Locations
France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
CHU Dijon
Dijon, France, 21000
CHU Grenoble
Grenoble, France, 38000
CH Issoire
Issoire, France, 63500
CHU Limoges
Limoges, France, 87042
Hospices Civils de Lyon
Lyon, France, 69000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Gautier CHENE, MD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01276340     History of Changes
Other Study ID Numbers: 1008433
Study First Received: January 11, 2011
Last Updated: May 16, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Urinary Incontinence
Urinary stress incontinence
Urinary urge incontinence
Women
electrical stimulation
KEAT stimulator
quality of life

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014