J Acquir Immune Defic Syndr. 2011 May 1; 57(1): e7-e12; 2011 Feb 21. [Epub ahead of print]
The Shang Ring Device for Adult Male Circumcision: A Proof of Concept Study in Kenya.
Barone MA, Ndede F, Li PS, Masson P, Awori Q, Okech J, Cherutich P, Muraguri N, Perchal P, Lee R, Kim HH, Goldstein M.
1EngenderHealth, New York, USA; 2Formerly with EngenderHealth, Kenya; 3Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, USA; 4Center for Biomedical Research, The Population Council, New York, USA; 5 EngenderHealth, Kenya; 6Homa Bay District Hospital, Homa Bay, Kenya; 7National AIDS/STD Control Programme, Nairobi, Kenya; 8 Formerly with the Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, USA.
OBJECTIVE: To assess safety, preliminary efficacy and acceptability of the Shang Ring, a novel disposable device, for adult male circumcision in Kenya.
METHODS: Forty HIV-negative men were recruited in Homa Bay, Kenya. Circumcisions were performed by a trained physician or nurse working with one assistant. Follow-up was conducted at 2, 7, 9, 14, 21, 28, 35 and 42 days after circumcision. Rings were removed on day 7. Pain was assessed using a visual analog scale (0=no pain,10=worst possible). Men were interviewed at enrollment and on days 7 and 42.
RESULTS: All 40 procedures were completed successfully. Mean procedure and device removal times were 4.8 (sd±2.0) and 3.9 (sd±2.6) minutes, respectively. There were six mild adverse events, including three penile skin injuries, two cases of edema, and one infection; all resolved with conservative management. In addition, there were three partial ring detachments between days 2-7. None required treatment or early ring removal. Erections with the ring were well tolerated, with a mean pain score of 3.5 (sd±2.3). By day 2, 80% of men were back to work. At 42 days all participants were very satisfied with their circumcision and would recommend the procedure to others.
CONCLUSION: Our results demonstrate that the Shang Ring is safe for further study in Africa. Acceptability of the Shang Ring among participants was excellent. With short procedure times, less surgical skill required, and the ease with which it can be used by non-physicians, the Shang Ring could facilitate rapid roll-out of male circumcision in sub-Saharan Africa.
PMID: 21346586 [PubMed - as supplied by publisher]
Editor's Note for this article in UNAIDS HIV This Week Issue 92