Pelvic floor muscle (PFM) training (PFMT) is a standard conservative first-line treatment for stress urinary incontinence (SUI) in women. However, the success of PFMT alone, without adjunctive therapies, has been hindered by the lack of adherence among women, 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 biofeedback (BF). The conventional BF device employed in clinical practice is invasive and involves the insertion of an intravaginal probe, causing pain or discomfort for women. Therefore, our team developed the PelviSense, a non-invasive BF device for use as a PFMT adjunct. The proposed randomised controlled trial (RCT) aims to (1) investigate the efficacy of PelviSense-assisted PFMT compared with unassisted PFMT in reducing SUI in women, and (2) identify the mechanisms underlying the beneficial effects of PelviSense-assisted PFMT for the treatment of SUI.

A prospective, two-arm, parallel-group RCT will be conducted. It will involve 132 women aged 18–60 years with SUI or stress-predominant mixed urinary incontinence, who will be randomised into PelviSense-assisted (n=66) or unassisted (n=66) PFMT groups using a computer-generated randomisation schedule. Supervised PelviSense-assisted and unassisted PFMT will be provided on a one-to-one basis for 30 min, three times per week, for 4 weeks. Following the supervised training period, participants will perform the exercises at home unsupervised for 24 weeks, with or without the PelviSense device, according to their assigned group. The primary outcome will be the severity of urine loss, measured using the 1-hour pad test. The secondary outcomes will be the severity of SUI symptoms, measured using the International Consultation on Incontinence Questionnaire-Short Form, and quality of life, measured using the Incontinence Impact Questionnaire-Short Form. The mediating outcomes will include PFM strength, measured using the Modified Oxford scale, as well as levator hiatus area and bladder neck position, measured by transperineal ultrasound. The outcomes will be assessed at baseline (week 0), postintervention (week 4) and at follow-up (week 28).

This RCT has received ethical approval from the Institutional Review Board of The Hong Kong Polytechnic University (approval number: HSEARS20211104002-02). Its findings will be disseminated to participants via written feedback on PFMT performance using the PelviSense device, to the general public via public lectures, to healthcare professionals via interactive workshops and to researchers via articles in peer-reviewed journals and presentations at national and international conferences.

NCT06126757.