Nonsurgical Device Effective for Adult Male Circumcision

Jill Stein

May 26, 2011

May 26, 2011 (Washington, DC) — A simple disposable device, known as PrePex, can be used to effectively circumcise male adults without anesthesia or a sterile environment and with no blood loss, and patients can return to work within hours, investigators announced here at the American Urological Association (AUA) 2011 Annual Scientific Meeting.

The device can handle the increase in HIV-prevention male circumcision in high-risk resource-limited settings like sub-Saharan Africa.

In all, "22 million of the 33.4 million HIV-infected individuals worldwide live in sub-Saharan Africa. Scale-up of adult male circumcision in this region is a challenge because the standard surgical procedure is relatively difficult to perform and requires a surgeon or highly skilled medical professional, along with expensive instruments," Muyenzi Leon Ngeruka, MD, a staff surgeon at Kanombe Hospital in Kigali, Rwanda, told Medscape Medical News. "In sub-Saharan Africa, there is a lack of medical infrastructure."

He added that a "benefit of the device is that it can be deployed by minimally trained healthcare professionals in urban or rural environments without the need for a sterile hospital setting. We therefore believe that the new device can facilitate a rapid scale-up of adult male circumcision."

Dr. Ngeruka presented results of a study of 50 healthy men, 18 to 35 years of age, who were recently circumcised using the device.

Multiple randomized controlled trials, conducted by the World Health Organization and the Joint United Nations Program on HIV/AIDS, have shown that male circumcision reduces the risk for HIV infection by 60%, and accordingly recommend an increase in male circumcision in areas with low circumcision rates, a high prevalence of HIV, and largely heterosexual epidemics. In Rwanda, the government recently launched an HIV prevention program, which aims to offer circumcision to up to 2 million adults in 2 years. The program includes counseling and testing, promotion of safe sexual practices, treatment of sexually transmitted infections, and condom use. Currently, only 15% of Rwandan men are circumcised.

Simple Procedure

The device — an elastic mechanism that fits closely around an inner ring, thwarting blood flow to the foreskin — remains in place for a week, after which the necrotic distal portion of the foreskin can easily be removed. Placement and removal of the device take less than 4 minutes, and no anesthesia is required at deployment or removal. Standard surgical circumcision is conducted under local anesthesia and takes 20 to 30 minutes.

Results show that complete circumcision was achieved in 100% of men. All study participants said they were happy with the results of the procedure.

No adverse events occurred while the device was on the foreskin, and there were no cases of device failure. A single case of mild diffuse edema occurred 2 days after the device was removed, but resolved after 2 days of ibuprofen therapy.

Men reported minimal pain — defined as a visual analog scale score below 2 — during placement and immediately after removal.

Overall, 29 men had complete healing — defined as complete epithelialization and no drainage after removal — within 2 weeks of device removal. Twenty men were completely healed within 3 weeks of device removal; 1 patient was completely healed within 4 weeks.

Men can return to work 3 or 4 hours after the procedure, rather than the several days required after surgical circumcision.

Urgent Need for Options

"Approximately 80 million men in sub-Saharan Africa are uncircumcised, and about 5% of them are HIV-positive, which means that about 75 million sub-Saharan African men are HIV-negative and are, theoretically, candidates for male circumcision," Ira D. Sharlip, clinical professor of urology at the University of California, San Francisco School of Medicine, and chair of the AUA Male Circumcision Task Force, told Medscape Medical News.

"Acceptability studies looking at how many men would accept a circumcision for the purpose of HIV risk reduction have found that 65% of men have said they would be interested in having a circumcision if it was free, locally available, and safe," he added. "This means that 65% of 75 million men — about 60 million men — are potential candidates for male circumcision. That's a huge number."

Currently, the most common technique for male circumcision in sub-Saharan Africa is surgery, which is performed by physicians in Swaziland and by clinical officers who are mid-level health practitioners in Kenya, Dr. Sharlip said. "If a device could be developed that's effective and safe and easier to use than a surgical procedure, it would be a big step forward. This device shows [that] potential."

The study was funded by the Rwanda Health Ministry, and the PrePex devices were donated by the manufacturer, Circ MedTech Limited. Dr. Ngeruka and Dr. Sharlip have disclosed no relevant financial relationships.

American Urological Association (AUA) 2011 Annual Scientific Meeting: Abstract 598. Presented May 15, 2011.

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