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

January 11, 2011
May 16, 2012
September 2010
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01276340 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Urinary Incontinence
Device: KEAT stimulator
electrical stimulation with KEAT stimulator : 4 times per week during 2 months
1
women with urinary incontinence
Intervention: Device: KEAT stimulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
February 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01276340
1008433
Yes
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Gautier CHENE, MD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP