Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence

Официальное название

Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence: A Randomized Controlled Trial

Обзор

This study will be conducted to determine the effect of virtual reality (VR) on pelvic floor training on postpartum stress urinary incontinence (SUI) .

Подробное описание

This study is significant as it explores the potential of VR technology to improve the effectiveness of pelvic floor rehabilitation, addressing a critical gap in postpartum care.

Postpartum SUI is a prevalent condition affecting approximately 30-40% of women after childbirth, significantly impairing their quality of life and psychological well-being. Traditional pelvic floor muscle training (PFMT) remains the first-line of treatment, yet adherence and engagement are often suboptimal due to monotony and lack of motivation. VR assisted rehabilitation presents an innovative approach to enhance patient participation by providing immersive, interactive, and engaging therapy sessions.

Furthermore, this research contributes to the growing body of evidence on digital health interventions in women's health, aligning with global trends toward tele-rehabilitation and personalized medicine By evaluating the efficacy and feasibility of VR in postpartum SUI rehabilitation, this study may inform clinical guidelines and encourage healthcare providers to adopt innovative technologies for better patient outcomes.

Lastly, improving postpartum SUI treatment has broader socioeconomic implications, as untreated SUI leads to increased healthcare costs and reduced work productivity.

Вмешательства

• Другое Pelvic floor muscle rehabilitation supported by an immersive VR
  The VR intervention, known as the VR Personality Project, will be delivered using an adjustable virtual reality headset equipped with integrated audio through the head-mounted display. Each participant will use lightweight, wireless Bluetooth controllers to engage and interact with the virtual environment. The Intervention will last for 8 weeks, with training sessions conducted three times per week under physiotherapist supervision. All participants will undergo baseline assessment prior to rand
• Препарат Medical treatment
  Duloxetine which is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases urethral sphincter tone will be used for both groups.

Первичные конечные точки

• Assessment of pelvic floor muscle strength [Срок оценки: 8 weeks]

Вторичные конечные точки (2)

• The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [Срок оценки: 8 weeks]
• Short Form-36 (SF-36) questionnaire [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Females, aged 22-35 years.
• Postpartum period: between 3 and 6 months after vaginal delivery .
• Able to perform basic pelvic floor contractions (Oxford Grade ≥ 2).
• Women who are multiparous(2-3times) and have delivered vaginally.
• Postpartum women with body mass index 18.5-30 kg/m²

Критерии исключения

• Females Diagnosed with neurological conditions affecting pelvic control (e.g., multiple sclerosis, spinal cord injury).
• History of pelvic floor surgery within the past 12 months.
• Known visual, vestibular, or cognitive impairments that interfere with VR use.
• Susceptibility to motion sickness or vertigo, worsened by visual simulation.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy - Cairo University — Giza

Идентификаторы

NCT: NCT07455838 · P.T.REC/012/006275

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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