ObjectiveTo compare the performance of three continence management devices and absorbent pads used by men with persistent urinary incontinence (>1 year) after treatment for prostate cancer. Patients and MethodsRandomised, controlled trial of 56 men with 1-year follow-up. Three devices were tested for 3 weeks each: sheath drainage system, body-worn urinal (BWU) and penile clamp. Device and pad performance were assessed. Quality of life (QoL) was measured at baseline and follow-up with the King's Health Questionnaire. Stated (intended use) and revealed (actual use) preference for products were assessed. Value-for-money was gathered. ResultsSubstantial and significant differences in performance were found. The sheath was rated as 'good' for extended use (e.g. golf and travel) when pad changing is difficult; for keeping skin dry, not leaking, not smelling and convenient for storage and travel. The BWU was generally rated worse than the sheath and was mainly used for similar activities but by men who could not use a sheath (e.g. retracted penis) and was not good for seated activities. The clamp was good for short vigorous activities like swimming/exercise; it was the most secure, least likely to leak, most discreet but almost all men described it as uncomfortable or painful. The pads were good for everyday activities and best for night-time use; most easy to use, comfortable when dry but most likely to leak and most uncomfortable when wet. There was a preference for having a mixture of products to meet daytime needs; around two-thirds of men were using a combination of pads and devices after testing compared with baseline. ConclusionsThis is the first trial to systematically compare different continence management devices for men. Pads and devices have different strengths, which make them particularly suited to certain circumstances and activities. Most men prefer to use pads at night but would choose a mixture of pads and devices during the day. Device limitations were important but may be overcome by better design. Keywordspenile compression device, body-worn urinal, sheath drainage system, King's Health Questionnaire, quality of life IntroductionProstate cancer is the commonest male cancer in the UK [1]. About 10-15% of men who undergo surgical or non-surgical treatment for prostate cancer will be left with lifelong urinary incontinence (UI) [2][3][4]. UI has major negative effects on quality of life (QoL) and social interactions [5][6][7][8][9][10][11], and is associated with long-term morbidities such as skin injury, UTI, falls, and increased hospital stays [12]. For those who do not regain continence, absorbent pads or alternative products and devices are required to maintain social continence.In addition to the usual choice of absorbent pads, other continence products include penile compression devices (clamp), sheath/condom drainage systems (sheath), and bodyworn urinals (BWU). In the UK the latter two are available on NHS prescription. However, their market share is low compared with the use of absorbent pro...

Background: 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.

Background: Penile clamps provide a means of preventing urinary incontinence in males following radical prostatectomy. In order for the devices to function, significant mechanical loads need to be applied to the penile tissues to close the urethra. However, such loads have the potential to cause damage to the vulnerable skin and underlying soft tissues. Accordingly, the study aimed to estimate the magnitudes of tissue deformations resulting from penile clamp application in three individual cases. Methods: Three individuals were recruited who currently use penile clamps to manage urinary incontinence following radical prostatectomy. Magnetic resonance images (MRI) of the penis were taken to produce a series of high contrast coronal and sagittal images both before and during the application of two commercially available clamps, modified for MRI compatibility. Tissue thickness measurements were estimated with the clamps in-situ and normalised to the unloaded baseline state. Results: The estimated magnitude of tissue deformations resulting from clamp application ranged between 68% and 84%. There were minimal differences in these deformations between the clamp designs, both of which appeared effective in closing the urethra. Local stress concentrations were observed in the tissues, which were deformed around the shape of the clamp. Conclusions: MRI enabled quantification of local tissue deformation during penile clamp application. The results revealed that clamps created large tissue deformations in all three cases, regardless of design. This information could inform the development of new clamp designs and materials to minimise the potential for tissue damage. Level of evidence: 4

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