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.
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.
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,
Parallel
PelviSense-assisted pelvic floor muscle training group
DeviceThe PelviSense consists of a high-precision, oval-shaped, wearable EMG sensor that displays electrical activity measured in PFMs on the user's mobile device. The reusable, wearable EMG sensor is non-invasive and can be attached to the user's perineal region. The mobile app provides real-time muscular feedback, displayed as EMG waveforms in microvolts. The mobile app can store data for up to 7 days, allowing participants to monitor their progress over the last 7 days in a graphical format.
Active comparator
Other interventionPelvic 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.
Stress urinary incontinence (SUI) symptom severity
(ICIQ-SF) will be used to measure SUI symptom severity.
Stress urinary incontinence (SUI) symptom severity
The disease-specific International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) will be used to measure SUI symptom severity.
Stress urinary incontinence (SUI) symptom severity
(ICIQ-SF) will be used to measure SUI symptom severity.
The severity of urine leakage
The one-hour (1-h) pad test will be used to quantify the severity of urine leakage.
The severity of urine leakage
The one-hour (1-h) pad test will be used to quantify the severity of urine leakage.
The severity of urine leakage
The one-hour (1-h) pad test will be used to quantify the severity of urine leakage.
Pelvic floor muscle strength
The valid and reliable Modified Oxford Scale (MOS) will be used to grade PFM.
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