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

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ClinicalTrials.gov Identifier: NCT02899520
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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)

Condition or disease Intervention/treatment Phase
Urinary Incontinence Other: Reference method Other: CMP ® method Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. USP (Urinary Symptoms Profile) score [ Time Frame: 38 weeks ]
    Urinary Symptoms Profile score



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899520


Contacts
Contact: Sophie FLANDIN-CRETINON +33(0)146252407 s.flandin-cretinon@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: FLANDIN-CRETINON    +3350°146252407    s.flandin-cretinon@hopital-foch.org   
Principal Investigator: Sophie FLANDIN-CRETINON         
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Sophie FLANDIN-CRETINON Hopital Foch

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02899520     History of Changes
Other Study ID Numbers: 2014/09
2014-A00709-38 ( Other Identifier: ANSM )
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders