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

Primary Purpose

Urinary Incontinence

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Reference method
CMP ® method
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Reference method

CMP ® method (Knowledge and Control of Perineum)

Outcomes

Primary Outcome Measures

USP (Urinary Symptoms Profile) score
Urinary Symptoms Profile score

Secondary Outcome Measures

Full Information

First Posted
September 9, 2016
Last Updated
December 31, 2019
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02899520
Brief Title
Evaluation of Programs of Reeducation for Urinary Incontinence in Woman
Acronym
ReedPerinee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Change in the clinical practices
Study Start Date
November 10, 2014 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Reference method
Arm Title
Group B
Arm Type
Experimental
Arm Description
CMP ® method (Knowledge and Control of Perineum)
Intervention Type
Other
Intervention Name(s)
Reference method
Intervention Description
Electrostimulation associated to perineal training
Intervention Type
Other
Intervention Name(s)
CMP ® method
Intervention Description
Method based on Knowledge and Control of Perineum
Primary Outcome Measure Information:
Title
USP (Urinary Symptoms Profile) score
Description
Urinary Symptoms Profile score
Time Frame
38 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie FLANDIN-CRETINON
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

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Evaluation of Programs of Reeducation for Urinary Incontinence in Woman

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