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."