Non-surgical methods of male circumcision (MC) that are simpler to use are required to accelerate uptake of voluntary medical male circumcision in sub-Sahara Africa. We aimed to assess safety and acceptability of PrePex device, a non-surgical MC method, among adolescent boys aged between 10 and 12 years in Kisumu, Kenya.
We implemented two PrePex procedures: day 0 foreskin removal procedure (FRP) and standard PrePex where the foreskin is left to self-detach. Questionnaires were administered to study participants and parents/legal guardians by clinicians after device placement. All study participants are being followed for 56 days; however, we report until day 42 for which follow-up is complete. Percentages were used to summarise acceptability and safety of the PrePex device. Chi-square test was used to assess the association between the PrePex procedure and safety.
Between April and August 2017, 214 adolescent males were enrolled; 41% (88/214) underwent the standard PrePex procedure. Of those enrolled, 44% had contraindications to PrePex circumcision; 65 had preputial adhesions and 30 had a narrow foreskin, with 21 having both conditions. Overall, 59% (56/95) of those with contraindications underwent day 0 FRP procedure. By day seven, 96% (192/201) kept penile hygiene as instructed, 79% (156/198) reported no pain and 96% (191/200) reported no difficulties in passing urine. However, these attributes were not associated with the type of PrePex procedure. Four of those who underwent day 0 FRP and five of those who underwent standard procedure reported missing school due to pain. Poor hygiene was associated with reporting pain (p<0.001). By day 21, 79% (151/193) had experienced epithelialization and 77% (148/193) granular tissue formation. Adolescents who underwent standard procedure were more likely to experience epithelialization and granular tissue formation (p<0.001) compared to those who underwent day 0 FRP. By day 42, all participants had experienced epithelialization and granular tissue formation. Only one moderate adverse event occurred during device placement. All participants found the procedure to be quite safe or very safe and were willing to recommend it to their peers.
Non-surgical circumcision using the PrePex device was safe and acceptable among adolescent males ages 10-12 years. Most participants reported no pain post device placement. Only one moderate intra-operative adverse event occurred.