A device that provides non-surgical male circumcision without anaesthetic or the need for stitches is effective, safe and can be used in non-sterile environments, investigators from Rwanda report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.
The single-centre study involved 55 young men who were circumcised using the PrePex device. This uses fitted rings to clamp the foreskin, leading to the death of tissue in the foreskin, which is then removed bloodlessly.
“The PrePex device applies controlled radial elastic pressure and hence requires no anesthesia,” write the investigators. “Use of the PrePex device is a nonsurgical procedure that can be performed in a standard consultation room, because the distal foreskin is necrotic when removed, bloodlessly.”
Randomised controlled trials have shown that circumcised men have their risk of infection with HIV reduced by between 53% and 60%. Both the World Health Organization and UNAIDS recommend consideration of male circumcision along with other preventative measures in countries with large, generalised and predominately heterosexual epidemics.
Only 15% of Rwandan men are circumcised. However, the government has plans to circumcise up to 2 million men. Given the country’s limited resources this will be difficult to achieve unless a non-surgical method of circumcision that can be performed by nurses in a non-sterile environment is found.
A method of male circumcision that could meet these requirements is the PrePex device.
Investigators at the Kanobe District and Military Hospital, Kigali, evaluated its safety and effectiveness in 55 men.
The study had two phases. In the first, the feasibility of the procedure was evaluated in five individuals. The device was applied and removed in a sterile environment by a physician. In the second phase, the remaining 50 patients were circumcised using PrePex in a non-sterile environment by a doctor or nurse.
The investigators explained that as the rings employed by PrePex only touch intact, healthy skin there is no need for its application or removal to be performed in a sterile environment.
All five patients enrolled in the feasibility phase of the study were successfully circumcised. No adverse events were reported, and all had completely healed within 28 days of the removal of the device.
Circumcision was also successful in all 50 individuals enrolled in the main phase of the study. The device and foreskin were removed between five and seven days after application, somewhat earlier than in the feasibility phase.
The first 20 patients in this phase of the study had the device applied and removed without any form of pain control. However, because some individuals reported discomfort, the remaining 30 patients were treated with 1 g of paracetamol 30 minutes before each procedure.
“We now believe that ibuprofen administered immediately after placement may be a better means of managing discomfort,” comment the investigators
Only one adverse event occurred after the removal of the device. This involved swelling and occurred in a patient with urethritis caused by a sexually transmitted infection. The swelling disappeared after two days of therapy with the anti-inflammatory drug ibuprofen.
Removal of the foreskin was accompanied by light oozing in two patients. However, this resolved after ten seconds of applied pressure.
A remnant of dead foreskin tissue remained in place after device removal, but this dropped off spontaneously within one to two weeks.
The physician removing the device and dead foreskin detected a slight odour in several instances, but none of the patients complained about smell.
Complete healing was achieved a median of 21 days after the removal of the device. In two patients, however, healing took up to 42 days.
Application of the device took a mean of 4.3 minutes, and its removal (and that of the dead foreskin tissue) a mean of 3.8 minutes.
“Although most of the procedures were handled by physicians, we noted no differences in procedure time, pain, adverse events, or healing time related to whether procedures were performed by a nurse or a physician,” write the authors. “Further study is warranted to document the feasibility of entrusting the procedure to nurses, but these preliminary results are encouraging and potentially important for large-scale male circumcision programs.”
The investigators conclude: “The PrePex device was safe and effective as a means of performing bloodless adult male circumcision that can be performed by non-physician staff without need for anesthesia, suturing, or sterile settings…these promising results could prove to be a significant advance in HIV prevention programs in sub-Saharan Africa.”
Bitega JP et al. Safety and efficacy of PrePex device for rapid scale up of male circumcision for HIV prevention in resource-limited settings. J Acquir Immune Defic Syndr, online edition, doi: 10.1097/QAD.0b013e3182354e65, 2011 (click here for the open-access article).