Evaluation of Programs of Reeducation for Urinary Incontinence in Woman

NCT02899520 | Terminated

• 2 other identifiers: 2014/092014-A00709-38
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• USP (Urinary Symptoms Profile) score

  Urinary Symptoms Profile score

  38 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

Reference method

Other: Reference method

Group B

EXPERIMENTAL

CMP ® method (Knowledge and Control of Perineum)

Other: CMP ® method

Interventions

Reference method OTHER

Electrostimulation associated to perineal training

Group A

CMP ® method OTHER

Method based on Knowledge and Control of Perineum

Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie FLANDIN-CRETINON

  Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: November 10, 2014
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: January 3, 2020

Record last verified: 2019-12

Locations

FR (1)