Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Urinary symptoms using the ICIQ-UI SF questionnaire
研究概览
简要总结
Stress urinary incontinence (SUI) affects around 40% of women and has a major impact on quality of life. The gold standard for the treatment of SUI is pelvicfloor rehabilitation, but this presents constraints in terms of availability of healthcare professionals, as well as organization and travel for patients. Innovative devices offer self-training exercises for the pelvicfloor, thus promoting motivation and adherence to treatment. The hypothesis of this study is to prove that the use of a pelvicfloor medical device combined with 2 rehabilitation sessions is not inferior to pelvic-perineal rehabilitation.
详细描述
Two groups will be studied:
- the control group will undergo 15 sessions of pelvic-perineal rehabilitation, corresponding to the gold standard.
- the intervention group will use the medical device 3 times a week for 15 minutes over a 3-month period, in addition to 2 rehabilitation sessions. The participant will then be able to modify her program according to her symptoms.
Recruitment will be carried out with the help of healthcare professionals. The investigators involved in the study will be physiotherapists specializing in pelvic-perineal rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate, severe or very severe stress urinary incontinence or mixed stress urinary incontinence (according to ICIQ-UI SF questionnaire score: moderate (6-12), severe (13-18) and very severe (19-21))
- •Patient aged between 18 and 60
- •Patient with a quality of life score measured with the I-QoL questionnaire less than or equal to 70 (score measured from 0 to 100, with poor quality of life: 0-35; average quality of life: 36-70; good quality of life: 71-100)
- •Not to have given birth in the last 6 months (to avoid post-partum physiological recovery)
- •Signed informed consent
- •Effective contraception throughout the study (declarative)
- •Patient must have a smartphone running at least Android 7 and iOS 12
- •Patient must be able to read and write French
排除标准
- •Patients with mild stress urinary incontinence or mixed stress urinary incontinence (ICIQ-UI SF score: mild (1-5))
- •Patient with a quality of life score above 70 (according to the I-QoL questionnaire: good quality of life: 71-100)
- •Patient undergoing other pelvic-perineal rehabilitation during the study period
- •Patients with neurological disease or congenital malformation, surgically or medically treated urinary incontinence or prolapse, perineal hypoesthesia or local conditions prohibiting the use of an intravaginal catheter
- •Infection of the bladder or vagina, or any symptoms associated with infection (itching, pain on urination or fever)
- •Contraindications to the use of the medical device
- •Anatomy making catheter placement difficult or impossible; in the case of prolapse, specialist advice is recommended.
- •Hemorrhage
- •Patients with genitourinary cancer (within the last 5 years)
- •Patients with extra-urethral "incontinence" (fistula, ectopic ureter)
- •Patients with severe urinary retention
- •Patient with vesico-ureteral reflux
- •Patients with hypoactive bladder
- •In case of peripheral denervation in the pelvic-perineal area, specialist advice is recommended
- •Patients wearing a sacral neuromodulation device
- •Patients in an exclusion period (determined by a previous or current study)
- •Impossibility of giving the subject clear information (subject in an emergency situation, difficulties in understanding the subject, etc.)
- •Patient under court protection
- •Patient under guardianship or curatorship
- •Pregnancy (positive pregnancy test)
- •Breastfeeding (as the hormonal impregnation caused by breastfeeding has a negative impact on perineal tone)
- •Use of Huawei and Oppo smartphones
研究组 & 干预措施
EMY (connected biofeedback medical device)
2 rehabilitation between M0 and M2 and pelvic-perineal exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months.
干预措施: EMY (Device)
standard
15 sessions of pelvic floor rehabilitation (gold standard)
结局指标
主要结局
Urinary symptoms using the ICIQ-UI SF questionnaire
时间窗: 6 months
The non-inferiority of 2 sessions of pelvic floor rehabilitation associated with the use of the EMY medical device compared with 15 sessions of pelvic floor rehabilitation (gold standard) on the urinary symptoms score at 6 months will be assessed using the ICIQ-UI SF questionnaire.
次要结局
- Cost-utility ratio using the EQ-5D questionnaire(0 month, 1 month, 3 months, 6 months, 12 months)
- Quality of life using the I-QoL questionnaire(0 month, 1 month, 3 months, 6 months, 12 months)
- Urinary symptoms using the ICIQ-UI SF questionnaire(0 month, 1 month, 3 months, 12 months)
- Qualitative component(1 month, 3 months, 6 months, 12 months)