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Re: Male Circumcision for HIV Prevention in Young Men in Kisumu, Kenya: A Randomised Controlled Trial
european urology 52 (2007) 605–610
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Words of Wisdom
Re: Male Circumcision for HIV Prevention in Young Men in Kisumu, Kenya: A Randomised Controlled Trial Bailey RC, Moses ST, Parker CB, Agot K, MacLean I, Krieger JN, Williams CFM, Campbell RT, O’NdinyaAchola JO Lancet 2007;369:643–56 Re: Male Circumcision for HIV Prevention in Men in Rakai, Uganda: A Randomized Trial Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankamba NK, Wabwire-Mangen F, Bacon MC, Williams CFM, Opendi P, Reynolds St J, Laeyendecker O, Quinn Th C, Wawer J Lancet 2007;369:657–66 Expert’s summary: Two recent randomised trials, one in Kisumo, Kenya (n = 2784) and the other in Rakai, Uganda (n = 4996), have demonstrated that male circumcision significantly reduces the risk of HIV acquisition in African men. The 2-yr HIV incidence was 2.1% in the circumcision group versus 4.2% in the control group ( p = 0.0065; Kisumu study). The relative risk of HIV infection in circumcised men was 0.47, corresponding to a risk reduction of acquiring an HIV infection of 53%. The Rakai study had similar results; HIV incidence was significantly decreased in the intervention group and not dependent on sociodemographic, behavioural, and sexually transmitted symptoms. Both randomised studies were stopped in early 2006 due to ethical reasons after interim analyses indicated significant HIV protective effects of circumcision. Both studies provide evidence that male circumcision significantly reduces the risk of
0302-2838/$ – see back matter
doi:10.1016/j.eururo.2007.04.089
HIV acquisition and has to be recommended for HIV prevention in men. Expert’s comments: Prevention of new HIV infections is the main goal to handle the worldwide HIV pandemic. Unfortunately, HIV testing and counselling, early diagnosis of sexually transmitted diseases, condom promotion, and behavioural changes have frequently been unsuccessful in restricting the spread of HIV [1]. Effective new HIV preventive interventions are needed. Even as long ago as 1986, the hypothesis was discussed that male circumcision might reduce HIV acquisition by sexual intercourse [2]. A number of ecologic and observational studies, including a meta-analysis of the available data, have supported this new theory for HIV prevention [3]. Biologically, the underlying plausible mechanism for the discussed protection is the evidence of HIV target cells in the inner mucosal surface of the human prepuce, whereas on the outer surface and the glans the target cells are protected by a layer of squamous epithelial cells [4]. Recently acquired other sexually transmitted infections, genital ulcer disease, and poor hygiene increase the susceptibility for the virus in this preputial area. The new published studies (Kisumu, Rakai) substantially confirm the HIV protective effect of male circumcision recently demonstrated in the Orange Farm Trial in South Africa [5] for African men. Although the data are not proven for Caucasians, it seems necessary to reflect on the routine integration of male circumcision into the protective health endeavours for men engaging in higher sexual risk behaviour in Europe. I believe that in these ‘‘high-risk’’ patients counselling should include circumcision not as a stand-alone procedure
606
european urology 52 (2007) 605–610
but as an effective component in the range of devices for HIV prevention. References [1] UNAIDS. Report in the global HIV/AIDS epidemic. Geneva: UNAIDS; 2006. [2] Fink A. N Engl J Med 1986;315:1167. [3] Weiss HA, et al. AIDS 2000;14:2361–70.
Re: Persistent Motile Sperm after Ligation Band Vasectomy Levine LA, Abern MR, Lux MM J Urol 2006;176:2146–8 Experts’ summary: To evaluate the efficacy of the VasClip1 ligation band vasectomy, the authors performed a retrospective analysis of their experience with this technique. They identified eight patients who had undergone the procedure in the standard fashion at their institution between September 2003 and March 2004. All patients were followed up after a minimum of 4 wk and 15 ejaculations. Azoospermia was defined as two consecutive semen analyses without evidence of sperm (not centrifuged). Mean time to both follow-up visits was 7 and 11 wk, respectively. Only six of eight (75%) patients demonstrated azoospermia at the time of follow-up. Both failures underwent scrotal exploration and repeat vasectomy with complete excision of the vas at the level of the application of the VasClip1. In both cases, instillation of methylene blue into the vasal lumen demonstrated patency despite the VasClip1 remaining in good position. Histologic examination clearly demonstrated formation of a sperm granuloma and fistulization in one of the two patients. Therefore, the authors have discontinued use of this technique. Experts’ comments: Research into new methods for male sterilization, both reversible and permanent, continues. New vasbased techniques including the VasClip1, the reversible inhibition of sperm under guidance (RISUG) technique, and the intra-vas device (IVD) have been developed over the past decade and introduced into clinical practice both in the United States and the rest of the world [1,2]. Some of the factors listed when describing the motivation for developing these techniques include ease of practice, operative
[4] McCoombe SG, et al. AIDS 2006;20:1491–5. [5] Auvert B, et al. PLos Med 2005;2:e298.
Wolfgang Weidner Department of Urology and Pediatric Urology, Justus Liebig Universita¨t Giessen, Giessen, Germany DOI:10.1016/j.eururo.2007.04.090
time, patient discomfort, and potential future reversibility. The VasClip1 device, first described by Kirby et al in 2006, was considered an improvement over vasectomy with regard to operative time, discomfort, and ease of practice [3]. They reported longterm follow-up data in 124 patients who had undergone the procedure; three failures were identified in their cohort, all due to shearing of the vas as a result of malpositioning of the device. Now the above authors report their experience, with an even more pronounced failure rate. Each of the procedures listed, and the VasClip1 procedure itself, were designed with the hope of supplanting vasectomy as the procedure of choice for male sterilization. This is despite the fact that vasectomy is easily learned and performed, has a minimal adverse effect profile, and is highly successful in most series with success rates >99.9% depending on the technique used [4]. One of the greatest difficulties with vasectomy, correctly emphasized by the authors in this series, is the need for patient education regarding risk of unwanted pregnancy in the immediate postoperative period. Despite clear explanation of this risk, many patients do not understand the need for secondary contraception while sperm distal to the site of the vasectomy remain present in the genitourinary tract and viable. Unfortunately, none of the other vas-based techniques improve on this risk; patients are still at risk of unwanted pregnancy if noncompliant during the immediate postoperative period, and in addition, they are at apparently even greater risk of late failure. Even still, continued research into alternate forms of male conception is crucially important from a world/public health standpoint. Nonsurgical treatment options would represent a significant advance. Most importantly, an effective pharmaceutical agent would obviate the need for a trained physician to perform a procedure. Although considerable barriers to the release of these agents
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Words of Wisdom
Re: Male Circumcision for HIV Prevention in Young Men in Kisumu, Kenya: A Randomised Controlled Trial Bailey RC, Moses ST, Parker CB, Agot K, MacLean I, Krieger JN, Williams CFM, Campbell RT, O’NdinyaAchola JO Lancet 2007;369:643–56 Re: Male Circumcision for HIV Prevention in Men in Rakai, Uganda: A Randomized Trial Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankamba NK, Wabwire-Mangen F, Bacon MC, Williams CFM, Opendi P, Reynolds St J, Laeyendecker O, Quinn Th C, Wawer J Lancet 2007;369:657–66 Expert’s summary: Two recent randomised trials, one in Kisumo, Kenya (n = 2784) and the other in Rakai, Uganda (n = 4996), have demonstrated that male circumcision significantly reduces the risk of HIV acquisition in African men. The 2-yr HIV incidence was 2.1% in the circumcision group versus 4.2% in the control group ( p = 0.0065; Kisumu study). The relative risk of HIV infection in circumcised men was 0.47, corresponding to a risk reduction of acquiring an HIV infection of 53%. The Rakai study had similar results; HIV incidence was significantly decreased in the intervention group and not dependent on sociodemographic, behavioural, and sexually transmitted symptoms. Both randomised studies were stopped in early 2006 due to ethical reasons after interim analyses indicated significant HIV protective effects of circumcision. Both studies provide evidence that male circumcision significantly reduces the risk of
0302-2838/$ – see back matter
doi:10.1016/j.eururo.2007.04.089
HIV acquisition and has to be recommended for HIV prevention in men. Expert’s comments: Prevention of new HIV infections is the main goal to handle the worldwide HIV pandemic. Unfortunately, HIV testing and counselling, early diagnosis of sexually transmitted diseases, condom promotion, and behavioural changes have frequently been unsuccessful in restricting the spread of HIV [1]. Effective new HIV preventive interventions are needed. Even as long ago as 1986, the hypothesis was discussed that male circumcision might reduce HIV acquisition by sexual intercourse [2]. A number of ecologic and observational studies, including a meta-analysis of the available data, have supported this new theory for HIV prevention [3]. Biologically, the underlying plausible mechanism for the discussed protection is the evidence of HIV target cells in the inner mucosal surface of the human prepuce, whereas on the outer surface and the glans the target cells are protected by a layer of squamous epithelial cells [4]. Recently acquired other sexually transmitted infections, genital ulcer disease, and poor hygiene increase the susceptibility for the virus in this preputial area. The new published studies (Kisumu, Rakai) substantially confirm the HIV protective effect of male circumcision recently demonstrated in the Orange Farm Trial in South Africa [5] for African men. Although the data are not proven for Caucasians, it seems necessary to reflect on the routine integration of male circumcision into the protective health endeavours for men engaging in higher sexual risk behaviour in Europe. I believe that in these ‘‘high-risk’’ patients counselling should include circumcision not as a stand-alone procedure
606
european urology 52 (2007) 605–610
but as an effective component in the range of devices for HIV prevention. References [1] UNAIDS. Report in the global HIV/AIDS epidemic. Geneva: UNAIDS; 2006. [2] Fink A. N Engl J Med 1986;315:1167. [3] Weiss HA, et al. AIDS 2000;14:2361–70.
Re: Persistent Motile Sperm after Ligation Band Vasectomy Levine LA, Abern MR, Lux MM J Urol 2006;176:2146–8 Experts’ summary: To evaluate the efficacy of the VasClip1 ligation band vasectomy, the authors performed a retrospective analysis of their experience with this technique. They identified eight patients who had undergone the procedure in the standard fashion at their institution between September 2003 and March 2004. All patients were followed up after a minimum of 4 wk and 15 ejaculations. Azoospermia was defined as two consecutive semen analyses without evidence of sperm (not centrifuged). Mean time to both follow-up visits was 7 and 11 wk, respectively. Only six of eight (75%) patients demonstrated azoospermia at the time of follow-up. Both failures underwent scrotal exploration and repeat vasectomy with complete excision of the vas at the level of the application of the VasClip1. In both cases, instillation of methylene blue into the vasal lumen demonstrated patency despite the VasClip1 remaining in good position. Histologic examination clearly demonstrated formation of a sperm granuloma and fistulization in one of the two patients. Therefore, the authors have discontinued use of this technique. Experts’ comments: Research into new methods for male sterilization, both reversible and permanent, continues. New vasbased techniques including the VasClip1, the reversible inhibition of sperm under guidance (RISUG) technique, and the intra-vas device (IVD) have been developed over the past decade and introduced into clinical practice both in the United States and the rest of the world [1,2]. Some of the factors listed when describing the motivation for developing these techniques include ease of practice, operative
[4] McCoombe SG, et al. AIDS 2006;20:1491–5. [5] Auvert B, et al. PLos Med 2005;2:e298.
Wolfgang Weidner Department of Urology and Pediatric Urology, Justus Liebig Universita¨t Giessen, Giessen, Germany DOI:10.1016/j.eururo.2007.04.090
time, patient discomfort, and potential future reversibility. The VasClip1 device, first described by Kirby et al in 2006, was considered an improvement over vasectomy with regard to operative time, discomfort, and ease of practice [3]. They reported longterm follow-up data in 124 patients who had undergone the procedure; three failures were identified in their cohort, all due to shearing of the vas as a result of malpositioning of the device. Now the above authors report their experience, with an even more pronounced failure rate. Each of the procedures listed, and the VasClip1 procedure itself, were designed with the hope of supplanting vasectomy as the procedure of choice for male sterilization. This is despite the fact that vasectomy is easily learned and performed, has a minimal adverse effect profile, and is highly successful in most series with success rates >99.9% depending on the technique used [4]. One of the greatest difficulties with vasectomy, correctly emphasized by the authors in this series, is the need for patient education regarding risk of unwanted pregnancy in the immediate postoperative period. Despite clear explanation of this risk, many patients do not understand the need for secondary contraception while sperm distal to the site of the vasectomy remain present in the genitourinary tract and viable. Unfortunately, none of the other vas-based techniques improve on this risk; patients are still at risk of unwanted pregnancy if noncompliant during the immediate postoperative period, and in addition, they are at apparently even greater risk of late failure. Even still, continued research into alternate forms of male conception is crucially important from a world/public health standpoint. Nonsurgical treatment options would represent a significant advance. Most importantly, an effective pharmaceutical agent would obviate the need for a trained physician to perform a procedure. Although considerable barriers to the release of these agents