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

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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Stress Incontinence; Urinary Mixed Incontinence
• Intervention / Treatment: Device: GYNEFFIK(R); Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13008
    • Marc Bernardini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GYNEFFIK(R); 30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods)	Device: GYNEFFIK(R); Vaginal electro-stimulation medical device
Other: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Worsening of ICIQ + Ditrovie Scales' Scores	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)	6 Months (or last measurement if premature ending)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICIQ Score	Quantitative analyses: difference = ICIQ_M6 - ICIQ_D0; variation (%)= 100 x (ICIQ_M6 - ICIQ_D0)/ICIQ_D0 Qualitative analysis * % of patients with a variation % <-10%, between -10% and +10%, >10%	6 Months (or last measurement if premature ending)
DITROVIE Score	Quantitative analyses: difference = DITROVIE_M6 - DITROVIE_D0; variation (%)= 100 x (DITROVIE_M6 - DITROVIE_D0)/(DITROVIE_D0 - 10) Qualitative analysis * % of patients with a variation % <-10%, between -10% and +10%, >10%	6 Months (or least measurement if premature ending)
ICG score	The ICG (clinical global impression) score is the subjective impression of the patient regarding the evolution of her own clinical condition. It will be determined between inclusion and M6 (or the last visit).	6 Months (or last measurement if premature ending)
SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey)	Difference = M6 -D0 Variation % = 100 x (M6 - D0)/D0	6 Months (or last measurement if premature ending)
HAD (Hospital Anxiety and Depression) scale	Qualitative analysis: improvement from sub-score > 10 to sub-score < 10; no change; worsening from sub-score < 10 to sub-score > 10	6 months (or last measurement if premature ending)
Bladder diary	A bladder diary will be filled by the patient for 3 days before the inclusion visit and then for 3 days before the final visit. The following items will be compared between D0 and M6: normal urinary episodes, incontinence episodes and drinks, in number and volume. Difference = M6 - D0 Variation % = 100 x (M6-D0)/D0	6 Months (or last visit if premature ending)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events		6 Months
Compliance	The lasts electro-stimulation sessions are recorded by the medical device.	6 Months

Collaborators and Investigators

• Sponsor: Effik
• Investigators: Principal Investigator: Marc Bernardini, MD

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Estimate): January 7, 2014
• Last Update Submitted That Met QC Criteria: January 6, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Urinary Stress Incontinence; Urinary Mixed Incontinence
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: 2012-A00235-38