PrePex circumcision surveillance: Adverse events and analgesia for device removal

Limakatso Lebina; Minja Milovanovic; Kennedy Otwombe; Pattamukkil Abraham; Mmatsie Manentsa; Susan Nzenze; Neil Martinson

doi:10.1371/journal.pone.0194271

PrePex circumcision surveillance: Adverse events and analgesia for device removal

PLoS One. 2018 Mar 26;13(3):e0194271. doi: 10.1371/journal.pone.0194271. eCollection 2018.

Authors

Limakatso Lebina¹, Minja Milovanovic¹, Kennedy Otwombe¹, Pattamukkil Abraham¹, Mmatsie Manentsa¹, Susan Nzenze¹, Neil Martinson^{1

2}

Affiliations

¹ Perinatal HIV Research Unit (PHRU), SA MRC Soweto Matlosana Collaborating Centre for HIV/AIDS and TB, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
² Center for TB Research, Johns Hopkins University, Baltimore, MD, United States of America.

Abstract

Background: The PrePex medical male circumcision (MMC) device is relatively easy to place and remove with some training. PrePex has been evaluated in several countries to assess feasibility and acceptability. However, several studies have reported pain associated with removal.

Objective: To assess safety of PrePex and whether analgesia administered prior to removal reduces pain experienced by participants.

Methods: A multi-site non-randomized, prospective cohort study in which adult (18-45 years old) males requesting PrePex device male circumcision, were enrolled in six South African clinics from July 2014 to March 2015. Participants were routinely provided with analgesia shortly after the surveillance commenced following a protocol review. Analgesia regimen for device removal depended on medication availability at clinics.

Results: Of 1023 enrolled participants who had PrePex placed, 98% (1004) had the device removed at a study clinic. Their median age was 25 (IQR: 21-30) years. HIV sero-positivity was 3.6% (37/1023). Nurses placed and removed half of all devices. Adverse events were experienced by 2.4% (25/1023) of participants; 15 required surgical intervention: device displacement (5/14), early removals (3/14), self-removals (5/14) and insufficient skin removed (2/14). Majority (792: 79%) of participants received analgesia. Most received either paracetamol-codeine (33%), lidocaine (29%) or EMLA and Oral Combination (28%). A lower proportion of participants who received any analgesia (except for lidocaine) prior to PrePex removal experienced severe pain compared to those who received no analgesia (16.6% vs. 29%: p = 0.0001).

Conclusion: Reported adverse events during this PrePex active surveillance were similar to previous reports and to those of surgical circumcision. Pain medication provided prior to removal is effective at decreasing severe pain during PrePex device removal.

Publication types

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

MeSH terms

Adolescent
Adult
Analgesia
Circumcision, Male / adverse effects
Circumcision, Male / instrumentation*
Circumcision, Male / methods*
Humans
Male
Pain / etiology
Pain Management
Patient Outcome Assessment
Young Adult

Associated data

figshare/5972197.v1

Grants and funding

The cites for Voluntary Male Circumcision were funded by Global Fund (www.theglobalfund.org/en/) (NM). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.