NCT01276340|CompletedDMC
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Sponsor study identifier
observational
450
1 country
6
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
February 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 11, 2011
Actual (reported)January 13, 2011
Actual (reported)December 2011
Actual (reported)February 2012
Actual (reported)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
change of urinary handicap after electrostimulation
2 months
satisfaction after electrostimulation
2 months
women with urinary incontinence
electrical stimulation with KEAT stimulator : 4 times per week during 2 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
women with stress, urge and mixed incontinence with an indication for perineal reeducation follow in gynecology
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
CHU Dijon
Dijon, 21000, France
CHU Grenoble
Grenoble, 38000, France
CH Issoire
Issoire, 63500, France
CHU Limoges
Limoges, 87042, France
Hospices Civils de Lyon
Lyon, 69000, France
Gautier CHENE, MD
CHU de Saint-Etienne
450 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2011
First Posted
January 13, 2011
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Peri-urethral Bulk Agent Injection of Bulkamid®
Contact the study team to confirm eligibility.
Primary Completion
December 2011
Actual (reported)Study Completion
February 2012
Actual (reported)Last Updated
May 17, 2012
Record last verified: 2012-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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