PaceyCuff for male stress urinary incontinence: first UK pilot evaluation of clinical outcomes and short-term cost offset.

BACKGROUND: Incontinence pads are the standard treatment for male stress urinary incontinence (SUI), especially after prostate surgery. Implantable devices are effective but limited by surgical waitlists and patient suitability. The PaceyCuff is a novel external urethral control device designed for extended wear while aiming to preserve blood flow, offering a less invasive option than surgery. This UK pilot study assessed preliminary clinical outcomes, tolerability, patient satisfaction, and short-term cost-offset observations. METHODS: Sixteen participants were enrolled. Two were excluded from the final analysis: one due to unrelated death and another due to inability to wear the PaceyCuff due to a buried penis. Baseline penile and finger peripheral oxygen saturation (SpO2), 3-h pad weight, 24-h pad count and patient-reported outcomes using the International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) and Quality of life questionnaire (QoL) were recorded. Participants were fitted with the PaceyCuff, and reassessed immediately, at 3 h and (via telephone) at two weeks and one month. RESULTS: ICIQ-UI scores fell from 17.4 to 7.2 at one month; QoL improved from 12.5 to 2.9. Urine loss decreased from 94 g to 10 g (p = .014). Pad use dropped from 4.2 to 1.7/day. Mean pain score 1.9/10, with two minor adverse events. Penile SpO2 remained stable, with no short-term clinical signs of ischaemia observed. The mean Charlson Comorbidity Index was 6.1. Weekly pad costs decreased from £42.34 to £17.95 (p = .002), potentially offsetting device costs within 13 weeks. CONCLUSIONS: The PaceyCuff shows potential as a low-cost conservative and well-tolerated option for male SUI, including in patients unsuitable for surgery. Larger scale studies are required to confirm the long-term efficacy and safety associated with PaceyCuff.