NCT02029027

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Effik · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-01-07
• Last updated: 2014-01-07

Locations

1 site across 1 country: France