Effectiveness and Cost-effectiveness of PelviSense, a Novel Biofeedback Device for Stress Urinary Incontinence in Women

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.

Inclusion Criteria: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.Exclusion Criteria: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)