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PrePex circumcision surveillance: Adverse events and analgesia for device removal
Limakatso Lebina1, Minja Milovanovic1, Kennedy Otwombe1
1Perinatal 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.
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.
Insights
Pain during PrePex device removal for male circumcision can be reduced with analgesia. This study found that providing pain medication before removal significantly decreased severe pain experienced by participants undergoing the procedure.
Area of Science:
- Medical devices
- Surgical procedures
- Public health
Background:
- The PrePex device offers a feasible and acceptable method for medical male circumcision (MMC).
- Previous studies indicate that pain during PrePex device removal is a concern for participants.
Purpose of the Study:
- To evaluate the safety of the PrePex device for male circumcision.
- To determine if analgesia administered before PrePex removal can effectively reduce pain.
Main Methods:
- A multi-site prospective cohort study involving 1023 adult males in South Africa.
- Participants received analgesia prior to device removal, with regimens varying based on clinic availability.
- Data on adverse events and pain experienced during removal were collected.
Main Results:
- 98% of participants had the PrePex device removed successfully at a study clinic.
- Adverse events were infrequent (2.4%), with most requiring no surgical intervention.
- Participants receiving analgesia (except lidocaine) reported significantly less severe pain during removal compared to those who received none (16.6% vs. 29%).
Conclusions:
- The PrePex device demonstrates a safety profile comparable to surgical circumcision.
- Pre-emptive analgesia is effective in mitigating severe pain associated with PrePex device removal.
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