Abstract
Background: Prostate cancer and bladder outlet obstruction, often treated surgically, are increasing in the aging population, leading to more cases of stress urinary incontinence (SUI). While implantable continence devices are beneficial for many, a growing number of frail patients are unsuitable for surgery and rely on incontinence pads or penile clamps, which are limited to three-hour use to prevent tissue ischaemia. We present the first UK evaluation of the new PaceyCuff penile clamp, designed for 24-hour wear while maintaining blood flow, to assess its efficacy, safety, and impact on patient quality of life.
Methodology: Men with urodynamically-proven SUI were identified. Baseline penile and finger peripheral oxygen saturation (SpO2), three-hour pad weight, 24-hour pad count and patient-reported outcomes (ICIQ-UI, QoL) were measured. Participants were then fitted with the PaceyCuff, and reassessed immediately, at three hours post-application and (via telephone) after two weeks.
Results: 13 men (average age 74, range 62-82) were recruited. ICIQ-UI scores decreased from 17 to 10, and QoL scores from 13 to 9. Average three-hour pad weight dropped from 94g to 10g and daily pad usage decreased from 4 to 0.9 pads. Participants reported good tolerance, with an average pain score of 1.8/10 and only 2 minor adverse effects (skin abrasion, transient pain). Penile SpO2 remained stable before, immediately after, and three hours post-use (76%, 82%, and 81% respectively). Sub-group analysis of patients over the age of 80 (n=4) confirmed equal effectiveness. (ICIQ-UI decreased 18 to 10, QoL decreased 13 to 9, three-hour pad weight decreased 77g to 9g, daily pad usage decreased 4 to 1.5 pads, average pain 1.5/10).
Conclusions: The PaceyCuff has demonstrated both efficacy and tolerability in managing SUI in a UK cohort for the first time and offers a potential treatment option for elderly patients ineligible for surgical intervention.