NEW YORK, June 28, 2012 /PRNewswire-USNewswire/ -- Study results published in the July issue of the Journal of AIDS provide further evidence of the safety, effectiveness, and acceptability among men and service providers of the Shang Ring, a novel medical device that could vastly increase access to male circumcision in countries hardest hit by the HIV epidemic. The latest finding by researchers from EngenderHealth, Weill Cornell Medical College, FHI 360 and Homa Bay, Kenya, confirms that the Shang Ring is safe to use and demonstrates that should men exceed the recommended timing for removing the device, there are no serious consequences.
Unlike surgical circumcision that requires only one visit, the procedure when done with the Shang Ring requires that the device stay in place for 7 days after the procedure. As there is little experience with the use of this device in the context of adult male circumcision programs, it is important to know that there will be no untoward effects if the man returns late or not at all for device removal.
"These positive results reinforce that the Shang Ring is safe, acceptable, and easy to use," said Dr. Mark Barone, Senior Clinical Advisor at EngenderHealth, which conducted the study with Weill Cornell Medical College and FHI 360. "The study found that devices left on longer than seven days fell off on their own. There are few or no risks to a patient's health should he not return to his health care provider for removal of Shang Ring at seven days, as recommended. This evidence further supports the importance of this method for increasing access to voluntary adult male circumcision."
The Shang Ring consists of two concentric plastic rings that lock together over the foreskin, and is then removed and disposed of seven days later. Surgical circumcisions typically take 20-40 minutes to complete and pose risks related to bleeding. But unlike conventional surgery, the Shang Ring is sutureless, involves minimal bleeding, and offers patients shorter procedure times (3-5 minutes). To achieve this, the device must remain in place for several days after the circumcision. While the recommendation is that the Shang Ring remain on the penis for seven days, in real world settings, with wide-scale use, some men could be delayed returning for Ring removal, or may not come back at all. The current study demonstrates that even if left on for longer, the Ring can still be safely removed, or will detach on its own without harm. Indeed, timing of removal or detachment was shown to have little effect on healing.
"The study results also affirm that acceptability is very high among men having a circumcision with the Shang Ring. As importantly, we now know that delaying removal of the Ring poses no adverse risks," said Dr. Philip Li, Associate Research Professor of Urology, and Reproductive Medicine at Weill Cornell Medical College and Director of Microsurgical Research and Training at Cornell's Institute for Reproductive Medicine. In addition, medical providers of male circumcision reported that using the Shang Ring was 'very easy' compared to a conventional surgical method.
Following conclusive evidence that male circumcision reduces the risk of heterosexual HIV transmission by up to 64%, the World Health Organization and the Joint UN Programme on HIV/AIDS (UNAIDS) recommended that countries include male circumcision as part of their HIV prevention programs. Yet, progress toward reaching large numbers of men with voluntary medical male circumcision is slow in most sub-Saharan African countries. Simple and easy-to-use devices, such as the Shang Ring, hold the promise of making services more widely available and faster.
Through a grant to FHI 360 from the Bill & Melinda Gates Foundation, EngenderHealth and Cornell are working with FHI 360 to study how the Shang Ring could transform the provision of male circumcision services in Africa. Dr. David Sokal of FHI 360, noted that, "the study could not have been successful without the support and active participation of Kenyan researchers, and especially the male circumcision team in Homa Bay." The Gates-funded research also includes a recently-completed randomized controlled trial to compare the Shang Ring with conventional surgical circumcision techniques, and a large field trial to examine use of the Shang Ring on a wider scale, which has recently been initiated in Kenya and Zambia.
EngenderHealth is a leading global reproductive health organization working to improve the quality of health care in the world's poorest communities. EngenderHealth empowers people to make informed choices about contraception, trains health providers to make motherhood safer, promotes gender equity, enhances the quality of HIV and AIDS services, and advocates for positive policy change. The nonprofit organization works in partnership with governments, institutions, communities, and health care professionals in 20 countries. EngenderHealth has been leading research on the national male circumcision program in Kenya since it launched in 2008. For more information, visit www.engenderhealth.org/mc.
About Weill Cornell Medical College
Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances — including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston. For more information, visit weill.cornell.edu.
About FHI 360
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research and technology– creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries, all 50 U.S. states and all U.S. territories. For more information, visit www.fhi360.org