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

Urinary Stress Incontinence Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02029027
• Other study ID #: 2012-A00235-38
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 6, 2014
• Last updated: January 6, 2014
• Start date: August 2012
• Est. completion date: February 2014

Study information

• Verified date: January 2014
• Source: Effik
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Conseil National de l'Ordre des Médecins
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Mixed Incontinence
• Urinary Stress Incontinence

Intervention

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

Locations

Country	Name	City	State
France	Marc Bernardini	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Effik

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events		6 Months	Yes
Other	Compliance	The lasts electro-stimulation sessions are recorded by the medical device.	6 Months	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No