The African nation of Rwanda recently set a goal of circumcising an estimated two million adult men by the end of 2012 to fight the spread of HIV, and is investigating a new nonsurgical device that is said to allow practitioners to perform the procedure in less than four minutes—without anesthesia.
The patent pending PrePex device includes an elastic mechanism that fits around an inner ring, trapping the penis foreskin—the loose fold of skin that covers its glans—which cuts its blood supply. The foreskin thereby dries up and is removed after a week. Neither anesthetics nor sterile settings nor sutures are required—and no blood is lost, according to health authorities studying the device. After the procedure the Rwandan government guidelines suggest that patients abstain from having sex for six weeks, which is also the case after conventional surgery. This device, it is hoped, could help scale up Rwanda's mass circumcision initiative.
Since 2007 World Heath Organization and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have promoted adult male circumcision as an additional means to fight HIV transmission in sub-Saharan countries with a high prevalence of the virus, low levels of male circumcision, and generalized heterosexual HIV epidemics. The rationale relies on studies suggesting that circumcised men reduce their own risk of HIV infection by about 60 percent.
Campaigns of mass circumcision have thus been launched in various countries, including Rwanda, where HIV prevalence is 3 percent but only 12 percent of adult males are currently circumcised. "If we only circumcise newborns, the effects will start in 15 years. We have to face the problem now," says Agnès Binagwaho, permanent secretary of Rwanda's Ministry of Health. "We are now offering, alongside counseling, testing and condom distribution an additional means of lowering transmission. It's a comprehensive approach."
The major obstacle to adult circumcision in most sub-Saharan countries remains the lack of medical infrastructures and trained health professionals to perform the operation. To overcome this, some countries such as Kenya now allow nurses to perform the surgical procedure. In others, like South Africa, the different stages are divided among nurses and physicians, to decrease physician time spent per procedure.
Now, the concept of a device that can bypass the need for any anesthesia or sutures is also raising interest. "There's absolutely no doubt that if one can perform male circumcision without anesthesia, you save time, money and it requires less expertise," says Kim Eva Dickson, senior adviser in WHO's HIV/AIDS department.
The price of the PrePex device, manufactured by Circ MedTech, incorporated in the Virgin Islands, has not yet been established. "The device was developed to be affordable for public health programs in Africa and is meant to be cost-saving for the government. The final price depends on quantities," said company CEO Tzameret Fuerst.
In March 2011 data on the first 40 patients from the safety and efficacy study was presented at the 18th Conference on Retroviruses and Opportunistic Infections in Boston. According to the researchers, all participants experienced excellent healing. "There was a 100 percent compliance rate, and the whole pain-management protocol in the study was two ibuprofens for the two to three hours of discomfort that follow the placement of the device," Binagwaho says. "It can be done anywhere—under a tent, in a classroom on the weekends—by a staff that is rapidly trained." The Rwandan government is currently training health care workers to perform the operation.
Dickson, who visited the site during the trial, agreed that initial results are encouraging. "We saw it done, and when we spoke to people who went through the procedure they seemed satisfied and the cosmetics looked good," she said. "I think there is potential, but we need more research evidence before we can approve of this method."
All external experts interviewed agreed that the device must be further investigated before it can be used systematically. "I've examined the PrePex. It's very promising in that it's very rapid to apply—two to three minutes, compared to the 20 minutes required for surgical circumcision," says Tim Farley, a scientist with WHO's Department of Reproductive Health and Research.” One of the problems is that there could be rare events that occur but it’s very difficult to detect those within this sort of limited studies. So the product needs to be studied in a larger number of men, and we will have to continue to monitor the safety and acceptability of the device.”
Rwanda will present safety and efficacy data on 50 patients at the American Urology Association in May 2011, and a randomized, controlled trial with 150 participants, designed to compare PrePex with the conventional surgical method is currently ongoing.
Today, clamping systems approved by the WHO are for use in infant circumcision. They include the Mogen clamp, the Gomco clamp and the Plastibell.
In 2004 the TaraKlamp (TK), a device that requires anesthesia, was tested among adults in South Africa. Despite initial enthusiasm, the study revealed high complication rates. Of 69 participants, 34 men were randomized to conventional surgery and 35 to the TK approach. Less favorable outcomes were systematically associated with the latter method.
Public sector facilities in some South African provinces, however, are using the device today.
Another apparatus currently being investigated among male adults in various sub-Saharan countries is the China-developed Shang Ring. This device, which requires local anesthesia, has proved safe, effective and acceptable in a small study involving 40 patients, published in the February 2011 issue of the Journal of Acquired Immune Deficiency Syndromes. A randomized control trial involving 400 male adults, comparing the Shang Ring with standard surgical methods, is expected to launch in Kenya and Zambia.
As the number of devices being tested is increasing, in January 2011 WHO set up an independent advisory committee. "The committee will systematically review new data on devices and advise on whether additional studies are needed before a device can be recommended for use in the scale-up of male circumcision programs," says Catherine Hankins, UNAIDS chief scientific adviser. "This is a minor operation, but on a major organ. We don’t want to lose any penises."