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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство EMY
  Patients in the "intervention" group (rehabilitation with the EMY medical device) will undergo 2 rehabilitation sessions with a physiotherapist trained in pelviperineology between M0 and M2. The aim of these sessions will be to learn proper perineal contraction and combat the deficits identified during the physiotherapist's assessment. They will have to perform pelvic-perineal re-education exercises with the EMY device on 3 different days a week, for 15 minutes, over a period of 3 months. Then,

Первичные конечные точки

• Urinary symptoms using the ICIQ-UI SF questionnaire [Срок оценки: 6 months]

Вторичные конечные точки (4)

• Quality of life using the I-QoL questionnaire [Срок оценки: 0 month, 1 month, 3 months, 6 months, 12 months]
• Urinary symptoms using the ICIQ-UI SF questionnaire [Срок оценки: 0 month, 1 month, 3 months, 12 months]
• Cost-utility ratio using the EQ-5D questionnaire [Срок оценки: 0 month, 1 month, 3 months, 6 months, 12 months]
• Qualitative component [Срок оценки: 1 month, 3 months, 6 months, 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU de Nantes — Nantes

Идентификаторы

NCT: NCT06285292 · RC24_0097

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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