Clinical trial NCT02029027: Interest of Intravaginal Electro-stimulation at Home by GYNEFFIK® Compared to Usual Care in Incontinent Patients With Prior Perineal Reeducation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Stress Incontinence
Urinary Mixed Incontinence
Keywords: Urinary Stress Incontinence
Urinary Mixed Incontinence
Lead sponsor: Effik
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 163
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Non-Worsening of ICIQ + Ditrovie Scales' Scores
timeFrame: 6 Months (or last measurement if premature ending)
Secondary outcomes:
measure: ICIQ Score
timeFrame: 6 Months (or last measurement if premature ending)
measure: DITROVIE Score
timeFrame: 6 Months (or least measurement if premature ending)
measure: ICG score
timeFrame: 6 Months (or last measurement if premature ending)
measure: SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey)
timeFrame: 6 Months (or last measurement if premature ending)
measure: HAD (Hospital Anxiety and Depression) scale
timeFrame: 6 months (or last measurement if premature ending)
measure: Bladder diary
timeFrame: 6 Months (or last visit if premature ending)
Other outcomes:
measure: Adverse Events
timeFrame: 6 Months
measure: Compliance
timeFrame: 6 Months
Locations:
city: Marseille
country: France
facility: Marc Bernardini
Study officials:
name: Marc Bernardini, MD
role: PRINCIPAL_INVESTIGATOR
References: