Use of Virtual Reality in the Treatment of Various Types of Urinary Incontinence in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) at 2 weeks
研究概览
简要总结
This assessor-blinded, non-randomized, parallel-group controlled study evaluated whether adding immersive virtual reality to pelvic floor muscle electrostimulation with electromyographic biofeedback improved incontinence-related quality of life in postmenopausal women with urinary incontinence. Participants received electrostimulation with EMG biofeedback alone or the same intervention preceded by a 20-minute immersive VR session.
详细描述
Urinary incontinence is a common condition among women and may adversely affect quality of life, psychological well-being, and social functioning. Conservative management may include pelvic floor muscle training, neuromuscular electrical stimulation, and electromyographic biofeedback. Virtual reality may be used as an adjunctive intervention intended to promote relaxation and engagement during rehabilitation; however, evidence regarding its use in women with urinary incontinence remains limited.
This study investigated immersive virtual reality as an adjunct to pelvic floor electrostimulation and electromyographic biofeedback in women with urinary incontinence. The VR intervention was intended to support relaxation and engagement during rehabilitation. It was delivered as a separate session immediately before electrostimulation and EMG biofeedback and included a gradually evolving garden environment, mandala-painting tasks, and guided breathing exercises. The VR system was not technically integrated with the EMG biofeedback device and did not provide real-time visualization of pelvic floor muscle activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 50-80 years, who are at least 12 months post-menopausal,
- •Diagnosed with urinary incontinence of grade I or II according to the Stamey classification,
- •No contraindications to participation (e.g., acute urinary tract infections, severe neurological disorders),
- •Provision of written informed consent to participate in the research experiment.
排除标准
- •Urinary incontinence of grade III or higher,
- •Presence of significant neurological conditions affecting bladder control,
- •Participation in other therapeutic interventions that could interfere with study outcomes,
- •Pregnancy,
- •Refusal or inability to provide informed consent.
研究组 & 干预措施
VR + ES Group
Participants received immersive virtual reality immediately before pelvic floor muscle electrostimulation and EMG biofeedback.
干预措施: Immersive Virtual Reality Therapy (Device)
VR + ES Group
Participants received immersive virtual reality immediately before pelvic floor muscle electrostimulation and EMG biofeedback.
干预措施: Pelvic Floor Muscle Electrostimulation with EMG Biofeedback (Device)
ES Group
Participants received pelvic floor muscle electrostimulation followed by EMG biofeedback without virtual reality.
干预措施: Pelvic Floor Muscle Electrostimulation with EMG Biofeedback (Device)
结局指标
主要结局
Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) at 2 weeks
时间窗: From enrollment to the end of treatment at 2 weeks.
The I-QOL is a 22-item instrument designed to assess the impact of urinary incontinence on quality of life in women. It covers three domains: avoidance and limiting behaviors, psychosocial impacts, and social embarrassment. Items are rated on a 5-point Likert scale (1 = extremely to 5 = not at all). Scores are transformed into a scale ranging from 0 to 100, with higher scores indicating better quality of life.
Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score
时间窗: Baseline and immediately after the 2-week intervention
The I-QOL is a 22-item instrument designed to assess the impact of urinary incontinence on quality of life in women. It covers three domains: avoidance and limiting behaviors, psychosocial impacts, and social embarrassment. Items are rated on a 5-point Likert scale (1 = extremely to 5 = not at all). Scores are transformed into a scale ranging from 0 to 100, with higher scores indicating better quality of life.
次要结局
- Change from Baseline in the Incontinence Impact Questionnaire - Short Form (IIQ-7) at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in the Gaudenz Questionnaire for the Assessment of Urinary Incontinence Severity at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in the King's Health Questionnaire (KHQ) at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in the Perceived Stress Questionnaire for Women (KPS) at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in Rosenberg Self-Esteem Scale (SES) at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in Presence and Grade of Pelvic Organ Prolapse (POP) at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in Urethral Length and Structural Integrity at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in Bladder Wall Morphology at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in Bladder Neck Mobility at 2 weeks(From enrollment to the end of treatment at 2 weeks.)
- Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Total Score at 2-Week Post-Intervention Follow-Up(Baseline and 2 weeks after completion of the intervention)
- Change from Baseline in the Incontinence Quality of Life Questionnaire (I-QOL) Subscale Scores(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.)
- Change from Baseline in the Incontinence Impact Questionnaire-Short Form (IIQ-7) Total Score(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention)
- Change from Baseline in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-Short Form (PISQ-12) Total Score(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention)
- Change from Baseline in the King's Health Questionnaire (KHQ) Domain Scores(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention)
- Change from Baseline in the Perceived Stress Scale (PSS-10)(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention)
- Change from Baseline in the Rosenberg Self-Esteem Scale (SES) Total Score(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention)
- Change from Baseline in Pelvic Floor Muscle EMG Activity at Rest and During Maximal Voluntary Contraction(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.)
- Change from Baseline in Bladder Diary Micturition Volume Parameters(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.)
- Change from Baseline in Micturition Frequency(Baseline, immediately after the 2-week intervention, and 2 weeks after completion of the intervention.)
研究者
Joanna Szczepańska-Gieracha
Professor
Wroclaw University of Health and Sport Sciences