The Safety and Acceptance of the PrePex Device for Non-Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

Abstract

ObjectivesTo assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda.MethodsIn an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing.ResultsThe PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001).ConclusionThe PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden.

A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe

“…The device-related AE (1.3%) was higher than the rates reported in Rwanda, which ranged from 0% to 0.77% [ 12 , 18 , 19 ], but lower than device-related AE rates reported in the large observational studies from Uganda and Kenya (2.3% and 6.8%. respectively) [ 20 , 21 ]. The clinical effectiveness of the device in this study as defined by WHO would be 98.7%, which emphasizes the point that surgical circumcision services will still be necessary unless effectiveness is 100%.…”

Adverse event profile of a mature voluntary medical male circumcision programme performing PrePex and surgical procedures in Zimbabwe

“…The proportion of clients experiencing adverse events (AEs) from MC is a widely used indicator of VMMC programme quality. The frequency of moderate and severe AEs from controlled trials and pilot programmes have ranged from 0.5% to 8% [1][2][3][5][6][7][8][9][10][11][12][13][14][15]. Because these studies generally include highly trained providers, frequent follow-up visits, and high follow-up rates, these findings may not be generalizable to routine programme implementation.…”

Trends in the Marginal Cost of Male Circumcision in Rural Rakai Uganda

“…To reduce overall program costs, cost saving strategies were employed including use of clinical officers (equivalent to physician’s assistants) [21] and research on use of the Shang Ring and PrePex devices, which require less time and equipment than conventional surgical procedures [22, 23]. …”