Piloting PrePex for Adult and Adolescent Male Circumcision in South Africa--Pain Is an Issue

PLoS One. 2015 Sep 25;10(9):e0138755. doi: 10.1371/journal.pone.0138755. eCollection 2015.

Abstract

Background: The World Health Organisation and the Joint United Nations Programme on HIV/AIDS have recommended the scale-up of Medical Male Circumcision (MMC) in countries with high HIV and low MMC prevalence. PrePex device circumcision is proposed as an alternate method for scaling up MMC.

Objective: Evaluate safety and feasibility of PrePex in South Africa.

Design: A multisite prospective cohort PrePex study in adults and adolescents at three MMC clinics. Participants were followed-up 8 times, up to 56 days after PrePex placement.

Results: In total, 398 PrePex circumcisions were performed (315 adults and 83 adolescents) their median ages were 26 (IQR: 22-30) and 16 years (IQR: 15-17), respectively. The median time for device placement across both groups was 6 minutes (IQR: 5-9) with the leading PrePex sizes being B (30%) and C (35%) for adults (18-45 years), and A (31%) and B (38%) for adolescents (14-17 years). Additional sizes (size 12-20) were rarely used, even in the younger age group. Pain of device application was minimal but that of removal was severe. However, described pain abated rapidly and almost no pain was reported 1 hour after removal. The Adverse Events rate were experienced by 2.7% (11/398) of all participants, three of which were serious (2 displacements and 1 self-removal requiring prompt surgery). None of the Adverse Events required hospitalization. The majority of participants returned to work within a day of device placement.

Conclusion: Our study shows that PrePex is a safe MMC method, for males 14 years and above. PrePex circumcision had a similar adverse event rate to that reported for surgical MMC, but device removal caused high levels of pain, which subsided rapidly.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Circumcision, Male / instrumentation*
  • Circumcision, Male / methods
  • Humans
  • Male
  • Pain / epidemiology
  • Pain / etiology*
  • Pain Measurement / statistics & numerical data
  • Prospective Studies
  • South Africa / epidemiology
  • Surgical Instruments / adverse effects*
  • Treatment Outcome
  • Young Adult

Grants and funding

The Bill and Melinda Gates Foundation funded the project through a grant to Population Services International (PSI) South Africa. The grant number was 50748, and a sub grant was given to WITS Health Consortium by Population Services International, grant number 3333. The grant information for Bill and Melinda Gates Foundation can be accessed at (http://www.gatesfoundation.org). PEPFAR through CDC funded PSI/SFH in South Africa, who funds high volume male circumcision sites at Witbank and Tsakane. The funders had no role in data collection and analysis, decision to publish or preparation of the manuscript, however they had a role in the study design. The funders requested that the study design has followed the World Health Organization framework of evaluating medical male circumcision devices.