Impact of Virtual Reality Pelvic Floor Training on Postpartum Stress Urinary Incontinence: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment of pelvic floor muscle strength
研究概览
简要总结
This study will be conducted to determine the effect of virtual reality (VR) on pelvic floor training on postpartum stress urinary incontinence (SUI) .
详细描述
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.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Pelvic floor muscle rehabilitation supported by an immersive VR + Medical treatment
Participants in this group will practice pelvic floor muscle rehabilitation supported by an immersive virtual reality system designed to enhance engagement and real-time biofeedback during exercise sessions in addition to medical treatment for SUI. The Intervention will last for 8 weeks, with training sessions conducted three times per week under physiotherapist supervision.
干预措施: Pelvic floor muscle rehabilitation supported by an immersive VR (Other)
Pelvic floor muscle rehabilitation supported by an immersive VR + Medical treatment
Participants in this group will practice pelvic floor muscle rehabilitation supported by an immersive virtual reality system designed to enhance engagement and real-time biofeedback during exercise sessions in addition to medical treatment for SUI. The Intervention will last for 8 weeks, with training sessions conducted three times per week under physiotherapist supervision.
干预措施: Medical treatment (Drug)
Medical treatment
Participants in this group will receive medical treatment for SUI.
干预措施: Medical treatment (Drug)
结局指标
主要结局
Assessment of pelvic floor muscle strength
时间窗: 8 weeks
Assessment of pelvic floor muscle strength through Kegel perineometer provides a non-invasive and reproducible method to evaluate pelvic floor muscle (PFM) function in women, particularly in cases such as stress urinary incontinence and postpartum recovery. Normal PFM strength typically ranges between 30-60 mmHg (approximately 20-40 cmH₂O), with variations depending on age and parity. Readings below 15 mmHg indicate weakness and possible dysfunction, whereas values above 40 mmHg reflect good to strong muscle strength.
次要结局
- The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)(8 weeks)
- Short Form-36 (SF-36) questionnaire(8 weeks)
研究者
Esraa Adel Khamees
Principal investigator
Cairo University