Spontaneous Detachment of the Shang Ring following Adult Male Circumcision
M. Barone1, Q. Awori2, P. Li3, R. Simba4, J. Okech4, A. Aduda4, P. Cherutich5, N. Muraguri5, J. Wekesa6, J. Nyanchoka7, P. Perchal1, P. Masson3, R. Lee3, M. Goldstein3,8, D. Sokal9
1. EngenderHealth, New York, USA;
2. EngenderHealth Nairobi, Kenya;
3. Center for Male Reproductive Medicine and Microsurgery, Department of Urology, Weill Cornell Medical College, New York, USA;
4. Homa Bay District Hospital, Homa Bay, Kenya;
5. FHI, Durham, NC;
6. National AIDS/STD Control Programme, Nairobi, Kenya;
7. Ministry of Medical Services, Nairobi, Kenya.
8. The Population Council, New York, USA; 9. Ministry of Public Health and Sanitation, Nairobi, Kenya
Background: The Shang Ring is a novel device for adult male circumcision that could facilitate circumcision scale-up. Results of a 2009 pilot study in Kenya suggested the device was safe and acceptable. The device is left on the penis for 7-10 days, then removed by a health provider. To explore safety issues if men did not return for removal and to help determine whether or not a separate removal visit is needed, we explored the possibility of spontaneous detachment when removal is delayed beyond 7 days.
Methods: Fifty HIV-negative men underwent a Shang Ring circumcision at the Homa Bay District Hospital, Kenya. Men were randomly assigned for removal at 7 (15 men), 14 (15 men) or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28 and 42 days after circumcision, and 2 days after removal.
Results: All circumcisions and removals were conducted without significant problems. Mean circumcision and removal times were about 6.6 (±2.5) and 2.6 (±0.8) minutes, respectively. Most men randomized to the 14- and 21-day removal groups had spontaneous detachments. Twenty-two men (44%) had complete spontaneous detachment, mostly between 11-15 days. Seven men (14%) had partial detachments between 8-14 days and requested removal due to pain or discomfort. Only three scheduled removals occurred at day 14 and one at day 21. Healing progressed normally in all men, and about 95% were “very satisfied.” The most common reasons mentioned for satisfaction were rapidity of the procedure and less pain than expected. No severe or serious adverse events occurred.
Conclusion: These data confirm that the Shang Ring is safe and easy to use according to label instructions. Spontaneous detachments occurred when the ring was left in place beyond 7 days. These data provide support for further research on the device as an option in countries where circumcision is being scaled up.
TUPE385 - Poster Exhibition, 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, 17-20 July 2011 - Rome, Italy. http://pag.ias2011.org/abstracts.aspx?aid=2712