Devices for performing voluntary medical male circumcision (VMMC) on adult men could help make the procedure easier to perform and possibly more accessible and acceptable to potential clients. Before these devices can be incorporated into VMMC programmes, however, research is needed to assess their safety, efficacy, acceptability, and feasibility compared to conventional surgical methods.
The World Health Organization (WHO), through its Technical Advisory Group on Innovations in Male Circumcision (TAG), has identified a minimum series of clinical studies to provide sufficient data to assess the efficacy and safety of a new male circumcision device or method. The following studies, described in the Framework for the Clinical Evaluation of Devices for Male Circumcision, constitute the clinical evaluation component of WHO’s prequalification process for male circumcision devices:
Initial studies to establish safety and acceptability;
At least two independent randomised controlled trials comparing the device against an established method of male circumcision performed by providers skilled in offering either method in settings of intended final use; and
At least two field studies of procedures involving relevant populations and types of facilities, performed by suitably trained and qualified mid-level or non-physician providers in settings of intended final use.
These studies have been completed for two devices, the PrePex™ and the ShangRing,™ and evaluated by WHO’s TAG. The results are summarised below and in a report on the TAG's January 2013 meeting, which informed the decision to prequalify the devices for circumcision of men ages 18 and older.1
In 2014 the TAG members reviewed additional data on 24,000 PrePex placements from 14 pilot implementation studies in 10 countries and available data on the use of PrePex and the ShangRing to circumcise boys ages 13 to 18 years. Their conclusions and recommendations are presented in a meeting report.2
In 2015, and again in 2016, WHO convened technical consultations to review reports of a rare but serious complication — tetanus infection following VMMC3 — and to recommend measures to reduce the risk. In September 2016, WHO updated its 2015 recommendations, calling for different risk mitigation measures by circumcision method, because the evidence indicated that the risk of tetanus was higher after circumcisions performed with an elastic collar compression device.4
The PrePex elastic collar compression device became the first adult male circumcision device to receive WHO prequalification on 31 May 2013, based on the results from eight studies involving 2,417 device placements conducted in Rwanda, Uganda, and Zimbabwe. In these studies, male circumcision performed using the PrePex device was successful in 99.5 percent of clients fitted with the device, and a large proportion of study participants expressed satisfaction with the results. The rate of complications across the studies was 1.7 percent, with nine cases requiring prompt surgical intervention to avoid long-term effects.
In two comparative studies, the mean combined time for placement and removal of the PrePex device was 5.7 minutes, compared to 19.2 minutes for conventional surgery (not including administration of anaesthesia). The time to complete wound healing after device placement was about a week longer than it is after conventional VMMC surgery.1
WHO prequalified the ShangRing, a collar clamp device, on 3 June 2015 for circumcision of males ages 13 and older based on the results of five studies of the device involving 1,983 device placements in Kenya, Uganda, and Zambia. In these studies, male circumcision performed using the ShangRing was successful in all but three clients, who were considered to have had insufficient skin removed. No study participants experienced serious complications; complications requiring medical intervention occurred in less than one in 100 procedures.
In two comparative trials, significantly more men who were circumcised with the ShangRing said they were very satisfied, compared to those who had had conventional surgery, and the total mean time for placement and removal of the ShangRing of 10.3 minutes was about half that of the conventional surgery (not including the administration of anaesthesia). Complete wound healing following male circumcision with the ShangRing took about one week longer than it did with conventional surgery.1
World Health Organization. WHO Technical Advisory Group on Innovations in Male Circumcision: Evaluation of Two Adult Devices. Meeting Report, 29-31 January 2013. Geneva: WHO, 2013.
World Health Organization. Report of the World Health Organization (WHO) Technical Advisory Group on Innovations in Male Circumcision, 30 September – 2 October 2014. Geneva: WHO, 2015.
Dalal S, Samuelson J, Reed J, et al. Tetanus disease and deaths in men reveal need for vaccination. Bull WHO 2016;94(8):613-21.
World Health Organization. Tetanus and Voluntary Medical Male Circumcision: Risk According to Circumcision Method and Risk Mitigation. Report of the WHO Technical Advisory Group on Innovations in Male Circumcision – Consultative Review of Additional Information, 12 August 2016. Geneva: WHO, 2016.