PrePex is the first known device to facilitate non-surgical medical adult MC that can claim all of the following no injected anesthesia, no blood no sutures no sterile settings.
The PrePex System, a new device and methodology for rapid adult male circumcision, works through a special elastic mechanism that fits closely around an inner ring, trapping the foreskin, which dries up and is removed after a week.
The Rwandan government developed interest in the device in 2009, after principal study investigator, from the Health Ministry Dr Jean Paul Bitega, attended a Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts in 2011, where the PrePex male circumcision device was among the topics discussed and over 4,000 leading researchers and clinicians from around the world participated.
The conference on the new technology came at a time when Rwanda was targeting to decrease its HIV incidence rate by 50% by circumcising two million adults in two years as part of a comprehensive HIV prevention strategy, according to the then Permanent Secretary in the Ministry of Health, Dr. Agnes Binagwaho, who is currently the Minister of Health.
According to a press statement released at that time, the experts picked particular interest in the study which demonstrated the safety and efficacy of the PrePex device without bleeding, sutures or anesthesia.
Bitega, a surgeon, noted; “The PrePex device has the potential to facilitate rapid scale-up in national programs for HIV prevention, an important need in Sub-Saharan Africa.”
The PrePex study was administered at Kanombe Military Hospital by Rwandan physicians.
An abstract of the first 40 subjects were presented at conference.
The study was setup for the first time in Rwanda with the help of Bitega and the Ministry of health who shared the study results with the world’s researchers working to understand, prevent, and treat HIV/AIDS and its complications.
In February 2012, with the study process still under way, Rwanda managed to safely conduct circumcision on 1,160 men using the PrePex device, where 888 procedures were performed in the framework of clinical studies.
During the same month February after scientifically validating the safety and efficacy of the device, its comparison to surgical circumcision, and simplicity in the hands of low cadre health care, the use of prepex device for circumcision gained WHO’s approval,” Mutabazi said.
No surgeon is needed for the procedure; a two-nurse team slides a grooved ring inside the foreskin and guides a rubber band to compress the foreskin in the groove.
After a week, the dead foreskin falls off like the stump of a baby’s umbilical cord or can be painlessly clipped off, said chief executive of PrePex.
This is part of what makes the patent pending device and method safe and simple to use, with very little training -you don’t even have to be a nurse.
This also enables a bloodless procedure no cutting of live tissue!, a critical factor in rural settings. There is no anesthesia-no needles!, no blood, no sutures and no sterile settings required, as the device comes in contact only with intact skin.
There were no infections or complications throughout the whole study from anyone while the device was in situ, confirming the safety of the technique. From discussions with patients after the study, one of the key benefits raised was that the procedure had no blood.
From device deployment to device removal, there were no clinical adverse events and no device-related incidents.
Following device removal, there was 1 mild adverse event of diffused edema that resolved with minimal intervention.
All subjects achieved the endpoint of complete circumcision, glans fully exposed.
Daily routines continued, and no absent or sick days were required beyond arriving for deployment and removal.
Average healing complete epithelialization and no drainage was 16.9 days post removal.
Minimal pain was reported during deployment and immediately after removal, with brief pain 30 to 40 seconds during device removal, which required no anesthesia.
There were 4 times more volunteers than were needed and all those selected arrived for the procedure, indicating acceptance.
The official noted that there was high demand for male circumcision, especially among young adults due to the fact that PrePex, the nonsurgical MC, takes significantly less time than surgical, is as safe, does not require injections or sterile settings, is bloodless and seems to be suitable for nurses.
The clamp is being used in quantity in Rwanda; in April 2012 the government is optimistic about the intention to achieve 2 million adult male circumcisions within the next 2 years, due to the splendid results shown by the PrePex device.
The Ministry of Health announced plans to roll out the new circumcision device, prepex, to more hospitals following its successful trials at Nyamata and Kanombe Military hospitals.
The programme set off in three district referral hospitals in order to scaled up to other health facilities, according to Dr Vincent Mutabazi, the Director of Research Grants Unit and Lead Investigator in the Prepex trials at the Rwanda Biomedical Centre.
In June 2012 the World Health Organization (WHO) Regional Director for Africa, Dr. Luis Gomes Sambo visited Rwanda and said that the success of the new circumcision device being tested in Rwanda can be part of the HIV prevention program, and a lesson for all African countries, south of the Sahara.
Sambo said that the new device is likely to improve the way circumcisions are performed and increase on the WHO bid to combat HIV/Aids, which is at a high prevalence on the African continent, especially in the sub-Saharan region
A few years ago, the World Health Organisation recommended that male circumcision be promoted as part of a comprehensive HIV prevention package after randomised and controlled studies in Africa showed male circumcision can reduce the lifetime risk of HIV infection by 53-60 percent.
The Joint United Nations Program on HIV and AIDS announced a 5-year plan to voluntarily circumcise 20 million men by 2015.
There are more than 38 million males in sub-Saharan Africa that could benefit from MC for HIV prevention by 2015. Surgical MC is impractical for nation-wide coverage in resource-limited settings.
Africa has at least 23 million people with HIV and a very high prevalence with 2 million new infections per year.
Of 217 eligible subjects, 144 were randomized to the PrePex/nonsurgical arm and 73 to the surgical arm. All subjects were circumcised in 10 working days. Nonsurgical MC was bloodless, without anesthesia, sutures, or sterile setting and with mean procedure time of 3.1 minutes (skin to skin), was significantly shorter than mean surgical procedure time 15.4 minutes (skin to skin). There were no device-related adverse events. Healing time of the PrePex arm was longer than the surgical arm.
The health study shows that PrePex is the safe and efficient System for mass male circumcision. It has the potential to facilitate rapid scale-up in national programs for HIV prevention, an imminent need in Sub-Saharan Africa.