Overview

This trial is active, not recruiting.

Conditions urinary stress incontinence, urinary mixed incontinence
Treatments gyneffik(r), usual care
Phase phase 4
Sponsor Effik
Start date August 2012
End date February 2014
Trial size 163 participants
Trial identifier NCT02029027, 2012-A00235-38

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods)
gyneffik(r)
Vaginal electro-stimulation medical device
(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
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

Primary Outcomes

Measure
Non-Worsening of ICIQ + Ditrovie Scales' Scores
time frame: 6 Months (or last measurement if premature ending)

Secondary Outcomes

Measure
ICIQ Score
time frame: 6 Months (or last measurement if premature ending)
DITROVIE Score
time frame: 6 Months (or least measurement if premature ending)
ICG score
time frame: 6 Months (or last measurement if premature ending)
SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey)
time frame: 6 Months (or last measurement if premature ending)
HAD (Hospital Anxiety and Depression) scale
time frame: 6 months (or last measurement if premature ending)
Bladder diary
time frame: 6 Months (or last visit if premature ending)

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Evaluation de l'intérêt de l'électrostimulation Intra-vaginale à Domicile Par Rapport à Une Prise en Charge Habituelle Dans la Prise en Charge de Patientes Incontinentes Ayant bénéficié d'Une rééducation périnéale
Principal investigator Marc Bernardini, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Effik.