American Urological Association (AUA), 2012; Atlanta, USA;
National Safety and efficacy study of PrePex, a new device facilitating non-surgical, bloodless circumcision with no anesthesia and no sutures, for resource limited settings (Rwanda)
Abstract Number: 1107106
The safety study of PrePex was conducted in Rwanda between March 2010 to December 2010 in three steps: 5 subjects for pre-safety/feasibility, which went through self detachment of the foreskin and demonstrated the capability for foreskin self detachment; a pivotal phase of 50 subjects; a final extension phase of another 50 subjects.
A study of 50 male subjects aged 18 to 35 years was conducted to assess the safety and efficacy of PrePex™, a new medical device that has the potential to facilitate rapid scale-up of male circumcision (MC) in resource limited settings. The device was explored in the context of the Republic of Rwanda’s national scale-up plan, which calls for circumcision of 2 million adult men in 2 years as part of its national HIV prevention strategy. The pivotal study was preempted by a feasibility stage that included 5 subjects.
The procedure was performed with no anesthesia. There were no cases of bleeding. There was no need for suturing. There were no clinical adverse events related to the procedure (from device Placement to device Removal) and there were no device-related incidents. Following device removal, there was 1 mild adverse event that was resolved with minimal intervention. Subjects returned to their daily routine shortly after placement and immediately after removal of the device. The median time for complete healingwas 21 days post device removal and the average was 25.3 days post device removal.
The PrePex device was found to be safe and effective for bloodless adult male circumcision, requiring no sterile settings, no anesthesia, and no suturing, furthermore, 100% of the subjects achieved the endpoint of complete circumcision, indicating device efficacy.