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

NCT02029027 | Unknown Phase 4 DMC

• 1 other identifier: 2012-A00235-38
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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

Keywords

Urinary Stress Incontinence; Urinary Mixed Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• ICIQ Score

  6 Months (or last measurement if premature ending)

• DITROVIE Score

  6 Months (or least measurement if premature ending)

• ICG score

  6 Months (or last measurement if premature ending)

• SF-12 Health Survey (Medical Outcomes Study Short-Form General Health Survey)

  6 Months (or last measurement if premature ending)

• HAD (Hospital Anxiety and Depression) scale

  6 months (or last measurement if premature ending)

Other Outcomes (2)

• Adverse Events

  6 Months

• Compliance

  6 Months

Study Arms (2)

GYNEFFIK(R)

EXPERIMENTAL

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

Device: GYNEFFIK(R)

Usual Care

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

Other: Usual Care

Interventions

GYNEFFIK(R) DEVICE

Vaginal electro-stimulation medical device

GYNEFFIK(R)

Usual Care 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Effik: lead

Study Sites (1)

Marc Bernardini

Marseille, 13008, France

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Bernardini, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

FR (1)