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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02899520
Other study ID # 2014/09
Secondary ID 2014-A00709-38
Status Terminated
Phase N/A
First received
Last updated
Start date November 10, 2014
Est. completion date October 18, 2019

Study information

Verified date December 2019
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date October 18, 2019
Est. primary completion date October 18, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Reference method
Electrostimulation associated to perineal training
CMP ® method
Method based on Knowledge and Control of Perineum

Locations

Country Name City State
France Hopital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary USP (Urinary Symptoms Profile) score Urinary Symptoms Profile score 38 weeks
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