Efficacy of a Video-Based Educational Program on Female Urinary Incontinence

Официальное название

Efficacy of an Educational Video-Based Program to Treat Urinary Incontinence in Women Referred for Pelvic Floor Rehabilitation

Обзор

The aim of this clinical trial is to assess the effectiveness of a 4-week video-based education program in enhancing urinary continence among women with urinary incontinence referred for pelvic floor rehabilitation The main question it aims to answer is : • Does a structured video-based education program reduce the symptoms of urinary incontinence before any pelvic floor muscle strengthening ? Researchers will compare this program to a paper document (providing similar information) to see if this improves urinary continence in women suffering from urinary incontinence. Participants will : * receive either the video-based education program or a paper information document (providing similar information) prior to the sessions with the physiotherapist * then follow pelvic floor rehabilitation sessions with the physiotherapist according to usual practice * complete the urinary incontinence questionnaire after the 4-week video education program (intervention group) or 4 weeks after receiving the paper document (control group), and after each pelvic floor rehabilitation session with the physiotherapist and at the end of the sessions * will be monitored at 1 and 2 years to evaluate urinary incontinence following the intervention.

Подробное описание

The video-based education program will include 4 workshops of 20 minutes each, at a rate of 1 video per week:

Video 1: Anatomy and physiology of the pelvic floor; Video 2: Physiology of the urinary tract; Video 3: Physiology of the digestive tract; Video 4: Pathophysiology of urinary incontinence and other pelvic floor disorders (genital prolapse and anal incontinence) and preventive measures in daily activities.

Вмешательства

• Поведенческое video-based education program
  The video-based education program will include 4 workshops of 20 minutes each, at a rate of 1 video per week: Video 1: Anatomy and physiology of the pelvic floor; Video 2: Physiology of the urinary tract; Video 3: Physiology of the digestive tract; Video 4: Pathophysiology of urinary incontinence and other pelvic floor disorders (genital prolapse and anal incontinence) and preventive measures in daily activities.
• Другое written information
  The control group will receive a paper information document (containing the same information as the intervention group) during the 4-week period

Первичные конечные точки

• Urinary incontinence score comparison between the 2 groups [Срок оценки: At the end of the video-based education program (5 weeks after inclusion)]

Вторичные конечные точки (12)

• Urinary incontinence score evolution in the intervention group [Срок оценки: from inclusion until the end of the video education program (5 weeks after inclusion)]
• Urinary incontinence score evolution in the control group [Срок оценки: from inclusion to 5 weeks following the distribution of the paper information document]
• Number of pelvic floor rehabilitation sessions required in the intervention group [Срок оценки: ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months]
• Number of pelvic floor rehabilitation sessions required in the control group [Срок оценки: ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months]
• Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the intervention group [Срок оценки: ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months]
• Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the control group [Срок оценки: ICIQ-SF score recorded after each pelvic floor rehabilitation sessions, through end of rehabilitation, an average of 3 months]
• Quality of life score evolution in the intervention group [Срок оценки: at inclusion and after the video-based education program (5 weeks after inclusion) , as well as between inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months]
• Quality of life score evolution in the control group [Срок оценки: at inclusion and 5 weeks after the distribution of the paper document information, as well as between inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months]
• Pelvic floor and sexual symptoms scores evolution in the intervention group [Срок оценки: between inclusion and the end of the video-based education program (5 weeks after inclusion), as well as between inclusion and the end of the pelvic floor rehabilitation sessions, an average of 3 months]
• Pelvic floor and sexual symptoms scores evolution in the control group [Срок оценки: at inclusion and 5 weeks after the distribution of the paper information document, as well as between inclusion and the end of the pelvic floor rehabilitation sessions, an average of 3 months]
• Patient-perceived improvement score evolution in the intervention group [Срок оценки: after the video-based education program (5 weeks after inclusion)and at the end of the pelvic floor rehabilitation sessions, an average of 3 months]
• Patient-perceived improvement score evolution in the control group [Срок оценки: 5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months]

Критерии участия

Критерии включения

• Any woman referred for pelvic floor rehabilitation sessions for urinary incontinence (defined as 'any involuntary leakage reported by the patient' according to the International Continence Society)
• Women requiring perineal rehabilitation for urinary incontinence
• Aged 18 years or older
• Having access to a connected device (tablet, smartphone, computer)
• Having a functional email address
• Covered by a social security scheme
• Informed, and written consent (signed by the participant and the investigator)

Критерии исключения

• Women unable to complete questionnaires (unable to read French or unable to write)
• Visually impaired individuals who cannot watch the video or read the printed material
• Genital prolapse extending beyond the hymen
• Documented neurological disorders
• Individuals receiving psychiatric care and those unable to express their consent
• History of pelvic fractures or dorsolumbar surgery
• Chronic pelvic pain
• Women who have given birth within the last 6 month
• Individuals with enhanced protection: minors, individuals deprived of liberty, individuals residing in a health or social institution, pregnant or breastfeeding women, adults under legal protection, and patients in emergency situations.

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 · 12 центров

• Mme ROSSIGNOL Marie - Kinésithérapeute - 5 place du Lavoir — Buxy
• Mme BLANCHARD Véronique - Kinésithérapeute — Chanceaux-sur-Choisille
• Mme GIRARD Delphine - kinésithérapeute - 14 rue de la Liberté — Embrun
• Mme LIAGRE Blandine - Kinésithérapeute - 120 rue de Chanzy — Hellemmes-Lille
• Mme BESSON Alice - Kinésithérapeute - 22 rue Benjamin Franklin — La Roche-sur-Yon
• Mme OLIVIER Mathilde - Groupe médical du Barry - 34 Bis Rue du Quatre Septembre — Montignac
• Mme CALONNE Hélène - Kinésithérapeute - 23 rue Franiatte — Montigny-lès-Metz
• Mme LE TILLY Marine - Kinésithérapeute - 181 rue Legendre — Paris
• … и ещё 4 центра

Идентификаторы

NCT: NCT07105150 · 2025-A00419-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗