The African nation of Rwanda recently set a goal of circumcising an estimated two million adult men by the end of 2012 to fight the spread of HIV, and is investigating a new nonsurgical device that is said to allow practitioners to perform the procedure in less than four minutes—without anesthesia.

The patent pending PrePex device includes an elastic mechanism that fits around an inner ring, trapping the penis foreskin—the loose fold of skin that covers its glans—which cuts its blood supply. The foreskin thereby dries up and is removed after a week. Neither anesthetics nor sterile settings nor sutures are required—and no blood is lost, according to health authorities studying the device. After the procedure the Rwandan government guidelines suggest that patients abstain from having sex for six weeks, which is also the case after conventional surgery. This device, it is hoped, could help scale up Rwanda's mass circumcision initiative.

Since 2007 World Heath Organization and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have promoted adult male circumcision as an additional means to fight HIV transmission in sub-Saharan countries with a high prevalence of the virus, low levels of male circumcision, and generalized heterosexual HIV epidemics. The rationale relies on studies suggesting that circumcised men reduce their own risk of HIV infection by about 60 percent.

Campaigns of mass circumcision have thus been launched in various countries, including Rwanda, where HIV prevalence is 3 percent but only 12 percent of adult males are currently circumcised. "If we only circumcise newborns, the effects will start in 15 years. We have to face the problem now," says Agnès Binagwaho, permanent secretary of Rwanda's Ministry of Health. "We are now offering, alongside counseling, testing and condom distribution an additional means of lowering transmission. It's a comprehensive approach."

The major obstacle to adult circumcision in most sub-Saharan countries remains the lack of medical infrastructures and trained health professionals to perform the operation. To overcome this, some countries such as Kenya now allow nurses to perform the surgical procedure. In others, like South Africa, the different stages are divided among nurses and physicians, to decrease physician time spent per procedure.

Now, the concept of a device that can bypass the need for any anesthesia or sutures is also raising interest. "There's absolutely no doubt that if one can perform male circumcision without anesthesia, you save time, money and it requires less expertise," says Kim Eva Dickson, senior adviser in WHO's HIV/AIDS department.

The price of the PrePex device, manufactured by Circ MedTech, incorporated in the Virgin Islands, has not yet been established. "The device was developed to be affordable for public health programs in Africa and is meant to be cost-saving for the government. The final price depends on quantities," said company CEO Tzameret Fuerst.

In March 2011 data on the first 40 patients from the safety and efficacy study was presented at the 18th Conference on Retroviruses and Opportunistic Infections in Boston. According to the researchers, all participants experienced excellent healing. "There was a 100 percent compliance rate, and the whole pain-management protocol in the study was two ibuprofens for the two to three hours of discomfort that follow the placement of the device," Binagwaho says. "It can be done anywhere—under a tent, in a classroom on the weekends—by a staff that is rapidly trained." The Rwandan government is currently training health care workers to perform the operation.

Dickson, who visited the site during the trial, agreed that initial results are encouraging. "We saw it done, and when we spoke to people who went through the procedure they seemed satisfied and the cosmetics looked good," she said. "I think there is potential, but we need more research evidence before we can approve of this method."

8 Comments

1. 1. ckarema 05:51 PM 3/16/11

   "It's only innovation which will change the face of the fight against HIV in the world" said today the Number 1 of UNAIDs Dr Michel SIDIBE, who came to see on live how well performing and revolutioning is this device. Michel Sidibe came in Rwanda and visited today the center of "Excellence of Prepex - Rwanda" at Nyamata Hospital in Bugesera District, Eastern Province. In this visit he was with the Permanent Secretary in the Ministry of Health, Dr Agnes Binagwaho and the 2 investigators Dr Corine Karema and Vincent Mutabazi, from TRACPlus which is the institution leading the comparison study between Prepex and the surgical circumcision. The preliminary findings of this study are promising showing an economic saving and a reduction by five the time of performing this procedure that require no anaesthesia neither a sterile environment. When Dr Sidibe walked out of the operating room, more than 30 young men and school students were waiting to be circumcised with the Prepex device as this is another way to get the Rwandan youth responsible of HIV prevention! This week 20 experts of African countries also visited Rwanda to see on live this incredible device. Rwanda is the place where scientific evidenced based revolutions happen for the health sector and for Africa this is just a piece which will save lives by reducing HIV transmission among the youth which is the future of the world.

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2. 2. koala_man 04:17 AM 3/17/11

   "The foreskin thereby dries up and can be safely removed after a week."
   
   The foreskin thereby slowly dies, and the necrotic tissue can be torn out after a week.
   
   I'm surprised it's not more painful. Are there risks of blood cloths or infections if the device is removed prematurely?
   
   It'll be interesting to see a comparison of the results to those of the surgery.

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3. 3. Hugh Young 07:03 PM 3/17/11

   "Rwanda, where HIV prevalence is 3 percent but only 12 percent of adult males are currently circumcised."
   
   More to the point, the HIV rate among non-circumcised men is 2.1%, but among circumcised men it is 3.8%, according to USAID: http://www.measuredhs.com/pubs/pdf/CR22/CR22.pdf
   
   So how can circumcising men reduce their HIV rate?
   
   A Uganda study (by circumcision advocates) started to show that circumcising men increases the risk to women, but they cut it short before it could reach statistical significance. (Lancet 374:9685, 229-37)
   
   The device in question will certainly work. Something similar has been used in Australia and New Zealand for years to castrate sheep.

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4. 4. positiveguy 10:18 PM 3/17/11

   HIV is not actually a death sentence. It is a disease that can be managed and be controlled by the individual who acquired it allowing him to live a long normal and productive life like anyone else. POZmingle the largest dating and support site for HIV singles claim that they have 200,000 HIV members, Most of them are here to find understanding, support and love. It is really a good thing that encourage each other, Leading a healthy life.

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5. 5. JDahiya in reply to Hugh Young 07:20 AM 3/18/11

   Is there really causation? Data that Hugh Young cites seem to show that the correlation is the other way round.
   
   I hope nobody is going around implying that this can prevent AIDS! That would be a sure recipe for people to get this done and proceed to take up more risky behaviour and worsen the situation.

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6. 6. Frederick Rhodes 08:55 AM 3/18/11

   Ladies be careful. The hardened skin that developes on the circumcised penis will increase your rates of vaginal erosion leading to increased health risks and total Hystorectomies. 60% reduction rate means the other men who get circumcised and get HIV anyways will more likely increase the rates the women get HIV over time bringing their population levels closer to extinction. It is only the Pro circumcision religious scientists that believe Circumcision is benifitial, not truthful scientists. Don't let them fool you into allowing to be done to infants and children because if done before puberty it messes with normal reproductive brain chemistry development.

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7. 7. Diesel67 04:31 PM 3/22/11

   Mr. Rhodes,
   Come to Brooklyn, NY and take a stroll in Williamsburg or Boro Park. Families there typically have eight,ten, twelve children, sometimes more. All the fathers were circumcised as infants. Is that what you call messing with normal reproductive bran chemistry? Do you have data showing that wives of circumcised men have more vaginal erosion and total hysterectomies than wives of uncircumcised men? The jury is out on any health benefits, but that's not why we do it.
   As for AIDS, the problem is sexual promiscuity, not the presence or absence of the foreskin. Stick to one woman who sticks to you and the rate of AIDS

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8. 8. Diesel67 04:33 PM 3/22/11

   Sorry, pushed the wrong button. . .
   
   Stick to one woman who sticks to you and the incidence of AIDS and all other venereal diseases falls to near zero. That's where it's been among Orthodox Jews for as long as anybody was keeping count.

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