Interest of Intravaginal Electro-stimulation at Home by GYNEFFIK® Compared to Usual Care in Incontinent Patients With Prior Perineal Reeducation

NCT ID: NCT02029027

Last Updated: 2014-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-02-28

Brief Summary

The aim of this study is to assess the benefit of GYNEFFIK®, a perineal electro-stimulator, during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI), that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK® electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained.

Conditions

Urinary Stress Incontinence; Urinary Mixed Incontinence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GYNEFFIK(R)

30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods)

Group Type: EXPERIMENTAL

GYNEFFIK(R)

Intervention Type: DEVICE

Vaginal electro-stimulation medical device

Usual Care

Any treatment / physiotherapy sessions / muscular training ... usually recommended and/or prescribed by the patient's general practitioner or gynaecologist with the exception of vaginal electro-stimulation

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Any treatment / physiotherapy sessions / muscular training ... usually recommended and/or prescribed by the patient's general practitioner or gynaecologist with the exception of vaginal electro-stimulation

Interventions

GYNEFFIK(R)

Vaginal electro-stimulation medical device

Intervention Type: DEVICE

Usual Care

Any treatment / physiotherapy sessions / muscular training ... usually recommended and/or prescribed by the patient's general practitioner or gynaecologist with the exception of vaginal electro-stimulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• out-patient over 18 years old, having understood and signed the Informed Consent Form
• seen for urinary stress incontinence or urinary mixed incontinence (with a major stress incontinence part) troubles
• spontaneously asking for help
• who can be followed for a long time

Exclusion Criteria

• Urinary Incontinence (UI) found out during medical interviewing without spontaneous complaint
• Urinary troubles due to neurological pathology (stroke, multiple sclerosis, ...)
• UI due to congenital malformation
• UI having led to surgery
• UI treated in the last 6 months
• UI within 24 weeks of Past Partum
• Pelvic surgery within 12 months
• On-going inflammatory or infectious neoplastic disease
• Perineal hypoesthesia
• Local conditions prohibiting the use of an intra-vaginal device (vaginal atrophia, continuous metrorrhagia, vaginal prolapse > 2°, ...)
• Pacemaker use
• Women of child bearing potential without effective method of contraception or planning to get pregnant in the next 12 months
• Intravaginal contraception
• Mental impairment or inability to understand or follow study instructions
• Patient who may not come back to the study visits
• Patient already enrolled for another study or having been enrolled in another clinical study in the past 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Effik

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bernardini, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Marc Bernardini

Marseille, , France

Countries

France

Other Identifiers

2012-A00235-38

Identifier Type: -

Identifier Source: org_study_id