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
试验速览
- 阶段
- 4 期
- 发起方
- Effik
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Non-Worsening of ICIQ + Ditrovie Scales' Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GYNEFFIK(R)
30 min-session of vaginal electro-stimulation by GYNEFFIK thrice a week for 6 months (except during menstrual periods)
干预措施: GYNEFFIK(R) (Device)
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
干预措施: Usual Care (Other)
结局指标
主要结局
Non-Worsening of ICIQ + Ditrovie Scales' Scores
时间窗: 6 Months (or last measurement if premature ending)
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)
次要结局
- Bladder diary(6 Months (or last visit 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))
- ICG score(6 Months (or last measurement if premature ending))
- ICIQ Score(6 Months (or last measurement if premature ending))
- DITROVIE Score(6 Months (or least measurement if premature ending))