Evaluation of Programs of Reeducation for Urinary Incontinence in Woman

NCT ID: NCT02899520

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-10

Study Completion Date

2019-10-18

Brief Summary

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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)

Detailed Description

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Reference method

Group Type ACTIVE_COMPARATOR

Reference method

Intervention Type OTHER

Electrostimulation associated to perineal training

Group B

CMP ® method (Knowledge and Control of Perineum)

Group Type EXPERIMENTAL

CMP ® method

Intervention Type OTHER

Method based on Knowledge and Control of Perineum

Interventions

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Reference method

Electrostimulation associated to perineal training

Intervention Type OTHER

CMP ® method

Method based on Knowledge and Control of Perineum

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie FLANDIN-CRETINON

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00709-38

Identifier Type: OTHER

Identifier Source: secondary_id

2014/09

Identifier Type: -

Identifier Source: org_study_id

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