Devices research

Devices for performing voluntary medical male circumcision (VMMC) on adult men and adolescent boys 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 were completed for two in situ devices (part or all of the device is in contact with the body for at least 24 hours):  the PrePex and the ShangRing.TM WHO’s TAG evaluated this evidence, which was summarised in reports on the TAG's meetings in 20131 and 2014. Studies on surgical assist devices have also been undertaken, but none of the devices has entered the prequalification process.

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, including different risk mitigation measures by circumcision method.4

Currently, only the ShangRing is WHO prequalified. In March 2019, WHO amended the original prequalification of the ShangRing, based on the results of additional studies conducted in Kenya,5–7 to include the use of a simpler “no-flip” technique and a topical rather than an injectable anaesthetic.

 

References

  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.

  2. 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.

  3. 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.

  4. 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.

  5. Barone MA, Li PS, Lee RK, et al. Simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment. Asian J Androl 2019;21(4):324–31.

  6. Awori Q, Li PS, Lee RK, et al. Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: results from a randomized controlled trial. PLoS One 2019;14:e0218066.

  7. Awori QD, Lee RK, Li PS, et al. Use of the ShangRing circumcision device in boys below 18 years old in Kenya: results from a pilot study. J Int AIDS Soc 2017;20(1):21588.

Selected References on male circumcision devices

Resources

 
thumbnail_ShangRing_review_TAU_Mar2021
Clinical Trials Using the Shang Ring Device for Male Circumcision in Africa: A Review

In a review published in the journal Translational Andrology and Urology, the authors summarize the results of studies of the use of the ShangRing device to perform adult male circumcision, which were conducted in Kenya, Uganda, and Zambia according to guidelines established by Worl

Read more
thumbnail.eval_2devices
Technical Advisory Group on Innovations in Male Circumcision: Meeting Reports

The World Health Organization (WHO) established a Technical Advisory Group (TAG) on Innovations in Male Circumcision in 2010 to advise WHO on the safety, acceptability, and public health need for male circumcision.

Read more
An Innovation in Public Health: Devices for Voluntary Medical Male Circumcision
An Innovation in Public Health: Devices for Voluntary Medical Male Circumcision

A collection of 17 articles, published in the Journal of Acquired Immune Deficiency Syndromes, examines research on the introduction of two devices for performing voluntary medical male circumcision on adults and adolescents.

Read more
WHO Informal Consultation on Tetanus and Voluntary Medical Male Circumcision: Meeting Report
WHO Informal Consultation on Tetanus and Voluntary Medical Male Circumcision: Meeting Report, 9-10 March 2015

The deliberations and recommendations of an expert consultation on voluntary medical male circumcision (VMMC) and tetanus are summarized in this report. 

Read more
WHO Prequalification of Male Circumcision Devices Public Report. Product: ShangRing™
WHO Prequalification of Male Circumcision Devices Public Report. Product: ShangRing

A public report from the World Health Organization on the 3 June 2015 prequalification of the ShangRing™ device for performing male circumcision summarises the review of the product and provides labeling information and instructions on use.

Read more
Wound Healing After VMMC
Wound Healing After Male Circumcision

Developed by a committee and led by the US Centers for Disease Control and Prevention, which incorporated inputs from the WHO Technical Advisory Group on Innovations in MC, this document provides a definition of clinical wound healing after voluntary medical male circumcision.

Read more
WHO Technical Advisory Group on Innovations - Evaluation of Two Devices
WHO Technical Advisory Group on Innovations in Male Circumcision: Evaluation of Two Adult Devices

The WHO Technical Advisory Group on Innovations in Male Circumcision met in January 2013 to review the clinical performance of two male circumcision devices, PrePex and the ShangRing.

Read more
Framework for Clinical Evaluation of Devices for MC
Framework for the Clinical Evaluation of Devices for Male Circumcision

Developed by WHO through a technical advisory group, this framework describes the steps and studies for evaluating the clinical performance, safety, and acceptability of a device for male circumcision.

Read more