Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device With Wearable Sensors for Stress Urinary Incontinence in Women: a Randomised Controlled Trial Alongside Economic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- Stress urinary incontinence (SUI) symptom severity
研究概览
简要总结
Aims: (1) Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for improving SUI symptom severity in women; (2) Compare the cost-effectiveness of the PelviSense device against PFMT alone for treating SUI in women; (3) Explore the views of women regarding the use of the PelviSense device as an adjunct to PFMT and the impacts of the PelviSense device on their lives and well-being.
Design and subjects: A sequential, embedded, experimental mixed-methods design, including a randomised controlled trial (RCT) and semi-structured focus groups, will be conducted alongside an economic evaluation. The proposed study will include 142 women with SUI or stress-predominant mixed urinary incontinence.
Interventions: Women will be randomly allocated to one of two groups (PelviSense or PFMT alone [control]). The PelviSense group will perform PFMT with assistance from the PelviSense device, and the control group will perform PFMT without biofeedback (i.e., PFMT alone).
Outcome measures: International Consultation on Incontinence Questionnaire-Short Form, one-hour pad test, Modified Oxford Scale, EQ-5D-5L, and electronic cost diary.
Data analysis and expected results: Statistical analysis will be conducted using analysis of covariance. The PelviSense group is expected to report significant improvements in primary and secondary outcomes compared with the PFMT alone group. The PelviSense group will yield cost savings and result in lower health care utility compared with the PFMT alone group.
详细描述
Background Pelvic floor muscle (PFM) training (PFMT) is a common conservative first-line treatment for SUI in women. However, the success of PFMT alone, without adjunctive therapies, has been hampered by the lack of training adherence among patients, who report the inability to contract the correct PFMs and limited motivation to perform PFMT exercises. Therefore, PFMT is often combined with adjunctive therapies, such as electromyography (EMG) biofeedback via an intravaginal probe (referred to as conventional biofeedback), transvaginal electrical stimulation (TVES), or weighted vaginal cones. However, PFMT adjunctive therapies that involve intravaginal probes/ cones are not preferred by women because they are invasive, and the vaginal insertion of probes/ cones can cause pain and discomfort. In addition, older women with atrophic vaginas have difficulty retaining probe/cones within the vaginal canal due to weak PFM tone.
To meet the existing need for a non-invasive PFMT adjunctive therapy, the research team developed the PelviSense. The PelviSense is an innovative, non-invasive biofeedback device with wearable EMG sensors, designed to assist individuals in isolating and strengthening PFMs by helping them distinguish correct PFM contractions (lifting or squeezing the muscles) from incorrect attempts (bearing down). A mixed-methods study, including a full-scale RCT and semi-structured focus groups, alongside an economic evaluation, will be conducted to evaluate both the effectiveness and cost-effectiveness of the newly developed PelviSense device for the treatment of SUI in women.
Aims:
Aim 1: Investigate the efficacy of PelviSense-assisted PFMT compared with PFMT alone for improving SUI symptom severity in women.
Aim 2: Compare the cost-effectiveness of the PelviSense device against PFMT alone for treating SUI in women.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •non-pregnant women with stress urinary incontinence (SUI),
- •aged 35 to 65 years,
- •women who experience mild to moderate SUI, as indicated by a pad weight gain of 1-50 g during the 1-hour pad test with stress test,
- •women with a score ≥24 on the Mini-Mental State Examination.
排除标准
- •women <6 months postpartum,
- •women with severe pelvic organ prolapse,
- •women with complicated SUI due to pelvic region radiation,
- •women with a body mass index (BMI) ≥30,
- •women with severe psychological problems impairing study participation,
- •women with mixed urinary incontinence (MUI) or urge urinary incontinence (UUI)
研究组 & 干预措施
PelviSense-assisted pelvic floor muscle training group
Women allocated to the PelviSense-assisted pelvic floor muscle training (PFMT) group will perform PFMT to contract their urethras while the wearable sensors are positioned close to the vagina (to measure pubococcygeus muscle activation). Exercises will be performed in antigravity (supine or side-lying) positions and will progress to against-gravity positions (sitting/ standing).
干预措施: PelviSense-assisted pelvic floor muscle training group (Device)
Pelvic floor muscle training (PFMT) alone group
Pelvic floor muscle training (PFMT) alone group: Women allocated to the PFMT alone group will perform unassisted PFMT. Exercise parameters, technique, and progression will be similar to those for the PelviSense-assisted PFMT group, but exercises will be performed without the PelviSense.
干预措施: Active comparator (Other)
结局指标
主要结局
Stress urinary incontinence (SUI) symptom severity
时间窗: 6 months
(ICIQ-SF) will be used to measure SUI symptom severity.
次要结局
- The severity of urine leakage(6 months)
- Economic evaluation(6-months)
- Pelvic floor muscle strength(6 months)
- Quality-adjusted life-years (QUALYs)(6 months)
研究者
Dr. Priya Kannan
Assistant Professor
The Hong Kong Polytechnic University