NCT01276340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

May 17, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

January 11, 2011

Last Update Submit

May 16, 2012

Conditions

Urinary Incontinence

Keywords

Urinary IncontinenceUrinary stress incontinenceUrinary urge incontinenceWomenelectrical stimulationKEAT stimulatorquality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • change of urinary handicap after electrostimulation

    2 months

  • satisfaction after electrostimulation

    2 months

Study Arms (1)

1

women with urinary incontinence

Device: KEAT stimulator

Interventions

KEAT stimulatorDEVICE

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

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • women
  • age \> 18 years
  • stress, urge or mixed incontinence with indication of perineal reeducation
  • follow in gynecology

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU Dijon

Dijon, 21000, France

Location

CHU Grenoble

Grenoble, 38000, France

Location

CH Issoire

Issoire, 63500, France

Location

CHU Limoges

Limoges, 87042, France

Location

Hospices Civils de Lyon

Lyon, 69000, France

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Incontinence, StressUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gautier CHENE, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 13, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

May 17, 2012

Record last verified: 2012-05

Locations

FR(6)