Medical Devices: Evidence and Research (Jun 2019)
Tissue response to applied loading using different designs of penile compression clamps
Abstract
Joseph MH Lemmens,1 Jackie Broadbridge,1 Margaret Macaulay,1 Rowland W Rees,2 Matt Archer,2 Marcus J Drake,3 Katherine N Moore,4 Dan L Bader,1 Mandy Fader11University of Southampton, School of Health Sciences, Southampton SO17 1BJ, UK; 2Department of Urology, University Hospital Southampton NHS Foundation Trust, Southampton, SO16 6YD, UK; 3Bristol Urological Institute, Southmead Hospital, Bristol, BS10 5NB, UK; 4Faculty of Nursing, University of Alberta, Edmonton, Alberta, T6G 1C9, CanadaBackground: Penile compression devices (PCD) or clamps are applied to compress the urethra and prevent urinary incontinence (UI). PCDs are more secure and less likely to leak than pads, allowing men the opportunity to participate in short-term, vigorous activities. However, they are uncomfortable, can cause pressure ulcers (PU) and affect penile blood flow. No objective assessment of tissue health has been undertaken to assess and compare different PCD designs and to provide guidance on safe use.Objective: This study was designed to evaluate existing PCDs in terms of their physiological response and potential for pressure-induced injury.Design, setting and participants: Six men with post-prostatectomy UI tested four selected PCDs at effective pressures, in a random order, in a controlled laboratory setting.Outcome measurements and statistical analysis: Using objective methods for assessing skin injury, PCDs were measured in situ for their effects on circulatory impedance, interface pressures and inflammatory response.Results and limitations: There was evidence for PCD-induced circulatory impedance in most test conditions. Interface pressures varied considerably between both PCDs and participants, with a mean value of 137.4±69.7 mmHg. In some cases, penile skin was noted to be sensitive to loading with elevated concentration of the cytokine IL-1α after 10 mins wear, indicating an inflammatory response. IL-1α levels were restored to baseline 40 mins following PCD removal.Conclusion: Skin health measures indicated tissue and blood flow compromise during the 50 mins of testing using all PCDs. Although there was an elevation in pro-inflammatory cytokines, PCDs did not cause sustained irritation and skin health measures recovered 40 mins after PCD removal. This research indicates that application of a clamp for one hour with an equal clamp free time before reapplication is likely to be safe. Longer periods are often recommended by manufacturers but have yet to be tested.Keywords: penile, compression, clamp, urinary, incontinence, pressure
