Absorbent incontinence pads are the standard conservative management for male stress urinary incontinence (SUI), particularly following prostate surgery. Implantable continence devices, while effective, are limited by surgical waitlists and patient suitability. The PaceyCuff, a novel external urethral control device designed to maintain blood flow and provide 24-hour continence, offers a potentially simpler and less invasive option.  

This study is the first UK evaluation of the PaceyCuff's efficacy, safety, and patient satisfaction in male SUI. Additionally, it will also perform a real-world cost-effectiveness analysis comparing PaceyCuff to incontinence pads.

16 participants were initially enrolled in the study. Two were excluded from the final analysis: one due to death (cause unrelated to study) and another due to inability to wear the PaceyCuff due to a buried penis.  

Baseline penile and finger peripheral oxygen saturation (SpO2), three-hour pad weight, 24-hour pad count and patient-reported outcomes (International Consultation on Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI), QoL) were first measured.  

Participants were then fitted with the PaceyCuff, and reassessed immediately, at three hours post-application and (via telephone) after two weeks and 1 month.

Reductions in ICIQ-UI and QoL scores were observed. The average ICIQ-UI score decreased from 17.4 to 9.5 at two weeks and 7.2 at one month. The QoL score decreased from 12.5 to 7.8 after two weeks and 2.9 after a month. After 3-hours of cuff usage pad weight decreased from an average of 94g to 10g. Pad usage was reduced from 4 to 0.9 per 24 hours. Penile SpO2 readings observed before, immediately after, and 3 hours after PaceyCuff usage (76%, 82%, and 81% respectively).

Within this study of 14 patients, the average ICIQ-UI score decreased from 17.4 at baseline to 9.5 at two weeks and 7.2 at one month. Average Quality of Life (QoL) scores improved from 12.5 to 7.8 and 2.9 at the respective time points.  

The 3-hour pad weight test showed a reduction in urine loss from 94g to 10g (p=0.014). Pad usage decreased from 4.2 pads/day to 1.8 at two weeks and 1.7 at one month. The device was well-tolerated, with a mean pain score of 1.9/10 and two minor adverse events (skin abrasion, transient pain).  

Penile oxygen saturation (SpO2) remained stable throughout the study period, with readings of 76%, 82%, and 81% at baseline, immediately post-application, and 3 hours post-application, respectively. 

The average Charlson Comorbidity Index was 6.1 (range 4-10). 

Cost-effectiveness: 

Participants used a variety of incontinence pad brands, including Always, TENA, and supermarket own-brand options. The average weekly pad expenditure significantly decreased from £42.34 (range: £5.04 - £107.52) to £17.95 (range: £5.04 - £31.08) at 28 days (p=0.002). Consequently, cost savings from reduced pad usage accumulated over time. By 13 weeks, these savings offset the £80 purchase price of the PaceyCuff, which has a 12-month durability, indicating sustained financial benefits with prolonged PaceyCuff use. Extrapolation to six months suggested a reduction in total pad usage from 741 to 300.

The PaceyCuff, representing a novel approach to male SUI management, has been evaluated in the UK for the first time. Demonstrating efficacy and good tolerability, including in surgically unfit patients, it provides continuous day and night continence without the risk of ischaemia. Improved continence and QoL, alongside minimal side effects, underscore its potential as a valuable treatment option.  
While an initial purchase cost exists, the PaceyCuff becomes cost-effective within a few months, with net savings realised after approximately 13 weeks. Long-term users benefit from a stable reduction in incontinence pad expenditure. Furthermore, its multi-use design significantly reduces single-use waste, minimising the environmental footprint associated with disposable incontinence products.