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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Urinary Stress Incontinence
- Sponsor
- Effik
- Enrollment
- 163
- Locations
- 1
- Primary Endpoint
- Non-Worsening of ICIQ + Ditrovie Scales' Scores
- Last Updated
- 12 years ago
Overview
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.
Investigators
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°, ...)
Outcomes
Primary Outcomes
Non-Worsening of ICIQ + Ditrovie Scales' Scores
Time Frame: 6 Months (or last measurement if premature ending)
The primary outcome is defined as the non worsening of the ICIQ (International Consultation on Incontinence modular Questionnaire) scale's score AND the DITROVIE scale's score (a specific scale to evaluate the perturbation of the quality of life during urinary troubles). The scores will be considered as maintained if they didn't increase more than 10% with the following calculation: ICIQ variation (%) = 100 x (ICIQ_M6 - ICIQ_D0)/ICIQ_D0 DITROVIE variation (%) = 100 x (DITROVIE_M6 - DITROVIE_D0)/(DITROVIE_D0 -10)
Secondary Outcomes
- Bladder diary(6 Months (or last visit if premature ending))
- SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey)(6 Months (or last measurement if premature ending))
- ICIQ Score(6 Months (or last measurement if premature ending))
- DITROVIE Score(6 Months (or least measurement if premature ending))
- HAD (Hospital Anxiety and Depression) scale(6 months (or last measurement if premature ending))
- ICG score(6 Months (or last measurement if premature ending))