Evaluation of Programs of Reeducation for Urinary Incontinence in Woman (ReedPerinee)

December 31, 2019 updated by: Hopital Foch
The objective of this study is to compare two methods of pelvic floor muscle training: reference method versus CMP ® method ( (Connaissance et Maîtrise de Périnée : Knowledge and Control of Perineum)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients more than 18 years old and less than 75 years
  • Patients presenting an urinary incontinence of effort or mixed symptomatic associated with a pelvic statics disorder
  • Patients with a perineale reeducation prescription
  • Patients affiliated to a national insurance scheme or benefiting from such a program
  • Patients having given her written consent form

Exclusion Criteria:

  • Nulliparous woman
  • Patients already operated for their incontinence
  • Patients with a prolapse of higher level at the stage II of the classification POP-Q (Pelvic Organ Prolapse Quantification)
  • Pregnant women
  • Patients presenting an associated anal incontinence,
  • Patients presenting a cancellation (section of marrow, syringomyelia for example) or an inversion of perineum control
  • Patients having given birth less than 6 months before the care
  • Patients having benefited from a pelvi-périnéale reeducation in the previous 12 months,
  • Patients presenting psychiatric disease
  • Patients presenting a vaginismus,
  • Patients presenting a contraindication to the practice of the electrostimulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Reference method
Other: Reference method
Electrostimulation associated to perineal training
Experimental: Group B
CMP ® method (Knowledge and Control of Perineum)
Other: CMP ® method
Method based on Knowledge and Control of Perineum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
USP (Urinary Symptoms Profile) score
Time Frame: 38 weeks
Urinary Symptoms Profile score
38 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Sophie FLANDIN-CRETINON, Hôpital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2014

Primary Completion (Actual)

October 18, 2019

Study Completion (Actual)

October 18, 2019

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/09
  • 2014-A00709-38 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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