Vasectomy: AUA guideline.

PURPOSE: The purpose of this guideline is to provide guidance to clinicians who offer vasectomy services. MATERIALS AND METHODS: A systematic review of the literature using the search dates January 1949-August 2011 was conducted to identify peer-reviewed publications relevant to vasectomy. The search identified almost 2,000 titles and abstracts. Application of inclusion/exclusion criteria yielded an evidence base of 275 articles. Evidence-based practices for vasectomy were defined when evidence was available. When evidence was insufficient or absent, expert opinion-based practices were defined by Panel consensus. The Panel sought to define the minimum and necessary concepts for pre-vasectomy counseling; optimum methods for anesthesia, vas isolation, vas occlusion and post-vasectomy follow up; and rates of complications of vasectomy. This guideline was peer reviewed by 55 independent experts during the guideline development process. RESULTS: Vas isolation should be performed using a minimally-invasive vasectomy technique such as the no-scalpel vasectomy technique. Vas occlusion should be performed by any one of four techniques that are associated with occlusive failure rates consistently below 1%. These are mucosal cautery of both ends of the divided vas without ligation or clips (1) with or (2) without fascial interposition; (3) open testicular end of the divided vas with MC of abdominal end with FI and without ligation or clips; and (4) non-divisional extended electrocautery. Patients may stop using other methods of contraception when one uncentrifuged fresh semen specimen shows azoospermia or ≤ 100,000 non-motile sperm/mL. CONCLUSIONS: Vasectomy should be considered for permanent contraception much more frequently than is the current practice in the U.S. and many other nations. The full text of this guideline is available to the public at http://www.auanet.org/content/media/vasectomy.pdf.

Therapeutic ultrasound as a potential male contraceptive: power, frequency and temperature required to deplete rat testes of meiotic cells and epididymides of sperm determined using a commercially available system.

BACKGROUND: Studies published in the 1970s by Mostafa S. Fahim and colleagues showed that a short treatment with ultrasound caused the depletion of germ cells and infertility. The goal of the current study was to determine if a commercially available therapeutic ultrasound generator and transducer could be used as the basis for a male contraceptive. METHODS: Sprague-Dawley rats were anesthetized and their testes were treated with 1 MHz or 3 MHz ultrasound while varying power, duration and temperature of treatment. RESULTS: We found that 3 MHz ultrasound delivered with 2.2 Watt per square cm power for fifteen minutes was necessary to deplete spermatocytes and spermatids from the testis and that this treatment significantly reduced epididymal sperm reserves. 3 MHz ultrasound treatment reduced total epididymal sperm count 10-fold lower than the wet-heat control and decreased motile sperm counts 1,000-fold lower than wet-heat alone. The current treatment regimen provided nominally more energy to the treatment chamber than Fahim's originally reported conditions of 1 MHz ultrasound delivered at 1 Watt per square cm for ten minutes. However, the true spatial average intensity, effective radiating area and power output of the transducers used by Fahim were not reported, making a direct comparison impossible. We found that germ cell depletion was most uniform and effective when we rotated the therapeutic transducer to mitigate non-uniformity of the beam field. The lowest sperm count was achieved when the coupling medium (3% saline) was held at 37 degrees C and two consecutive 15-minute treatments of 3 MHz ultrasound at 2.2 Watt per square cm were separated by 2 days. CONCLUSIONS: The non-invasive nature of ultrasound and its efficacy in reducing sperm count make therapeutic ultrasound a promising candidate for a male contraceptive. However, further studies must be conducted to confirm its efficacy in providing a contraceptive effect, to test the result of repeated use, to verify that the contraceptive effect is reversible and to demonstrate that there are no detrimental, long-term effects from using ultrasound as a method of male contraception.

Criticisms of African trials fail to withstand scrutiny: male circumcision does prevent HIV infection.

A recent article in the JLM (Boyle GJ and Hill G, "Sub-Saharan African Randomised Clinical Trials into Male Circumcision and HIV Transmission: Methodological, Ethical and Legal Concerns" (2011) 19 JLM 316) criticises the large randomised controlled trials (RCTs) that scientists, clinicians and policy-makers worldwide have concluded provide compelling evidence in support of voluntary medical male circumcision (VMMC) as an effective HIV prevention strategy. The present article addresses the claims advanced by Boyle and Hill, demonstrating their reliance on outmoded evidence, outlier studies, and flawed statistical analyses. In the current authors' view, their claims portray misunderstandings of the design, execution and interpretation of findings from RCTs in general and of the epidemiology of HIV transmission in sub-Saharan Africa in particular. At the same time they ignore systematic reviews and meta-analyses using all available data arising from good-quality research studies, including RCTs. Denial of the evidence supporting lack of male circumcision as a major determinant of HIV epidemic patterns in sub-Saharan Africa is unsubstantiated and risks undermining the evidence-based, large-scale roll-out of VMMC for HIV prevention currently underway. The present article highlights the quality, consistency and robustness of the scientific evidence that underpins the public health recommendations, guidance, and tools on VMMC. Millions of HIV infections will be averted in the coming decades as VMMC services scale-up to meet demand, providing direct benefits for heterosexual men and indirect benefits for their female partners.

No-needle local anesthesia for adult male circumcision.

PURPOSE: We used a local anesthetic jet injection technique for adult male circumcision. This method eliminates needle use and may decrease the fear of local anesthetic injection used for male circumcision. MATERIALS AND METHODS: We recruited 60 men seeking voluntary adult male circumcision into the study from June to September 2009. We used a MadaJet Medical Injector to deliver a high pressure spray of 0.1 ml 2% plain lidocaine solution directly through the penile skin circumferentially around the proximal third of the penis. All men underwent circumcision using the Shang Ring and were evaluated for anesthetic safety, efficacy and acceptability. Pain was measured on a visual analog scale. RESULTS: The average volume of 2% lidocaine anesthetic solution delivered by jet injection was 0.1 ml with a mean total of 0.9 ml per circumcision procedure. More than 85% of men did not require supplemental anesthesia. Anesthetic onset required approximately 45 seconds from the time that injections were completed. Mean pain scores for immediate postoperative, 24-hour postoperative, ring removal and post-ring removal events were 0.1, 6.8, 2.2 and 0.9, respectively. In 4 patients (6.67%) mild urethral bleeding resolved with pressure, resulting in technique modification. CONCLUSIONS: No-needle jet injection is safe and effective for adult MC. The technique efficiently delivers local anesthesia with rapid onset in men undergoing circumcision. This needle-free approach may enhance the popularity of adult male circumcision.

Quinacrine sterilization and gynecologic cancers: a case-control study in northern Vietnam.

BACKGROUND: Over 100,000 women worldwide have been sterilized by insertion of quinacrine into the uterus to induce tubal scarring. Concern has been expressed about possible carcinogenicity, and specifically the risk of uterine cancer. METHODS: From 2001 through 2006, we conducted a population-based, case-control study of gynecologic cancers in 12 provinces in northern Vietnam, where relatively large numbers of women had received quinacrine. Cases of incident cervical, ovarian, and uterine cancer were identified at provincial hospitals or at referral hospitals in Hanoi. For each case, 3 age- and residence-matched controls were randomly selected from the population registries of the case's home community. RESULTS: The prevalence of quinacrine exposure was 1.2% among cases and 1.1% among controls. For cervical cancer, analysis of 606 cases (9 exposed) and their 1774 matched controls (18 exposed) produced an odds ratio of 1.44 (95% confidence interval = 0.59-3.48) (adjusted for several covariates including human papillomavirus risk score). For ovarian cancer, based on 262 cases (3 exposed) and 755 controls (8 exposed) and adjusted for age and number of years of ovulation, the odds ratio was 1.26 (0.21-5.45). For uterine cancer, none of the cases-including 23 cases of leiomyosarcoma-was exposed to quinacrine. The 95% confidence interval, based on 161 cases (none exposed) and 470 controls (7 exposed) and adjusted only for age, was 0-1.85. CONCLUSION: We found no evidence of a relationship between quinacrine sterilization and gynecologic cancer.

A lifetime cancer bioassay of quinacrine administered into the uterine horns of female rats.

This study investigated if quinacrine can induce a tumorigenic response in rats when administered in a manner similar to the intended human use for female non-surgical sterilization. Young sexually mature female rats received two doses of quinacrine (or 1% methylcellulose control) into each uterine horn approximately 21 days apart, and were observed for 23 months after the second dose administration. Dose levels were 0/0, 0/0, 10/10, 70/70, and 70/250-350 mg/kg (first dose/second dose), which represent local doses in the uterus at approximate multiples of 1x, 8x and 40x the human dose (mg quinacrine/g uterine weight) used for female non-surgical sterilization. Rats were observed for viability, clinical signs of toxicity, and changes in body weight and food consumption. At necropsy, selected organs were weighed, macroscopic observations were recorded, and tissues were collected, fixed, processed, and examined for microscopic pathologic findings. Acute quinacrine toxicity was evident during the dosing period but did not affect long-term survival. Non-neoplastic findings were more common in treated animals than controls, providing evidence of the appropriateness of the bioassay. The incidence of uncommon tumors of the reproductive tract was similar to controls at doses of 10/10mg/kg but increased with dose level and was significantly greater than controls at >or=70/70 mg/kg. We conclude that two doses of quinacrine administered approximately 21 days apart into the uterus of young sexually mature rats at a local dose approximately 8 times the human dose used for non-surgical female sterilization increased the lifetime risk of tumor development in the reproductive tract.

[The need for high-quality training and surgical standards for adult male circumcision in China].

Although HIV is a significant problem in Africa, HIV infection rates are rising rapidly in other regions such as Asia and South America. International health organizations have recognized the need to develop effective strategies to check the worldwide transmission of HIV. Studies have demonstrated the significant reduction of HIV, HPV, HSV-2 and other STD infection rates with male circumcision (MC). Although numerous MC techniques are available, there are no standardized protocols and surgical training programs. Studies have shown that the standardization of MC techniques coupled with training programs can significantly reduce complication rates. High complication rates have been a primary obstacle to the implementation of MC services. We recommend the establishment of surgical standards and training protocols prior to the promotion of MC services in China.

[A recommendable standard protocol of adult male circumcision with the Chinese Shang Ring: outcomes of 328 cases in China].

OBJECTIVE: Standardization of and training in adult male circumcision can significantly reduce its complication rate. Currently no such program exists for its standardization and training, making it difficult to guarantee the quality of male circumcision services. We therefore established a standardized surgical protocol for adult male circumcision in China using the Shang Ring, and applied it to a clinical study examining the performance of the Shang Ring in adult male circumcision. METHODS: A total of 328 adult men aged 18-58 (mean 27.8) years, 25 with phimosis and 303 with redundant prepuce, underwent circumcision with the Shang Ring, and evaluation of the operation time, pain scores (using the visual analog scale), postoperative complications, time for wound healing, and their satisfaction with the postoperative appearance. RESULTS: The operation time was 4.7 +/- 1.3 minutes. The pain scores were 0. 2 +/- 0.6 during the surgery, 1.6 +/- 1.0 twenty hours postoperatively, 1.7 +/- 1.1 twenty hours prior to the ring removal, and 2.7 +/- 1.4 during the ring removal. Complications included infection in 2 (0.6%), bleeding in 2 (0.6%), and wound dehiscence in 2 (0.6%) of the patients. None of the patients with wound dehiscence required postoperative suturing and all were managed conservatively instead. Sixteen of the patients (4.9%) experienced penile edema. The time for complete wound healing after circumcision was 20.3 +/- 6.7 days. The rate of the patients'satisfaction was 99.7% (327/328). CONCLUSION: The standard protocol of adult male circumcision with the Shang Ring has the advantages of short operation time, slight pain, low rate of complications, and high satisfaction and acceptance of the patients. Strict standardization of the surgical protocol can maximize its clinical advantages for adult male circumcision.

Contraceptive effectiveness of two insertions of quinacrine: results from 10-year follow-up in Vietnam.

BACKGROUND: This study was conducted to evaluate the long-term effectiveness of two insertions of quinacrine pellets for nonsurgical sterilization among women in northern Vietnam. STUDY DESIGN: Observational cohort study of 1335 women who received two quinacrine insertions between 1989 and 1993. RESULTS: About 90% of the study population participated in the last round of interviews. Cumulative follow-up time for this cohort was 14,294 person-years. The 1-, 5- and 10-year cumulative pregnancy probabilities for quinacrine were 3.3% (95% CI, 2.4-4.3), 10.0% (95% CI, 8.4-11.6) and 12.1% (95% CI, 10.4-13.9), respectively. Pregnancy estimates with quinacrine in this cohort were higher than that reported from US-based research on surgical tubal sterilization and higher than results of quinacrine sterilization in Chile. Quinacrine effectiveness was better among older women. CONCLUSION: The effectiveness of quinacrine in Vietnam was lower than other forms of sterilization. Factors such as inconsistent training and use of various insertion techniques may have contributed to the relatively high failure rate.

Safety of quinacrine contraceptive pellets: results from 10-year follow-up in Vietnam.

BACKGROUND: This study was conducted to evaluate long-term safety of quinacrine pellets for nonsurgical sterilization among women in Vietnam. STUDY DESIGN: Observational cohort study of 2735 women who had quinacrine insertions between 1989 and 1993 compared to 1623 women who received an intrauterine device (IUD). RESULTS: Cumulative follow-up times for the quinacrine and IUD cohorts were 28,697 and 17,382 person-years, respectively, and losses to follow-up were 6% and 7%, respectively. Quinacrine users had a higher incidence of ectopic pregnancy compared to IUD users (risk ratio, 2.2; 95% confidence interval, 1.06-4.54); the risks of cancer, hysterectomy, pelvic/gynecologic surgery and death were similar in the two groups. Two quinacrine insertions appeared to lower the risk of ectopic pregnancy to that of surgical tubal occlusion. CONCLUSIONS: Use of quinacrine in this cohort appeared to have minimal health risks. Other research, including preclinical studies, needs to be considered in an overall evaluation of whether the combination of safety and efficacy provide a basis for quinacrine's approval by appropriate regulatory agencies.

Men's Understanding of and Experiences During the Postcircumcision Abstinence Period: Results From a Field Study of ShangRing Circumcision During Routine Clinical Services in Kenya and Zambia.

BACKGROUND: Men's understanding of counseling messages after voluntary medical male circumcision (VMMC) plays an important role in whether they follow them. Data on triggers for early resumption of sex may be useful as scale-up of VMMC for HIV prevention continues in sub-Saharan Africa. METHODS: Data on understanding of post-VMMC abstinence recommendations, resumption of sex, condom use, and triggers for resuming sex were collected from participants during a follow-up interview 35-42 days after ShangRing circumcision in Kenya and Zambia. RESULTS: Of 1149 men who had ShangRing circumcision, 1096 (95.4%) completed follow-up. Nearly all (99.2%) reported being counseled to abstain from sex post-VMMC; among those, most (92.2%) recalled the recommended abstinence period was 6 weeks. Most men (94.1%) reported that the counselor gave reasons for post-VMMC abstinence and recalled appropriate reasons. Few (13.4%) men reported resuming sex at 35-42 days' follow-up. Among those, 54.8% reported never using a condom post-VMMC. Younger participants (odds ratio 0.3, 95% confidence interval: 0.2 to 0.5, P < 0.0001) and those reporting at least some condom use at baseline (odds ratio 0.5, 95% confidence interval: 0.3 to 0.7, P = 0.0003) were less likely to report resuming sex. Among men who reported some condom use, most (71.5%) said condoms were much easier or easier to use after circumcision. Men reported various reasons for early resumption of sex, primarily strong sexual desire (76.4%). CONCLUSIONS: Most men reported awareness of and adherence to the counseling recommendations for post-VMMC abstinence. A minority reported early resumption of sex, and, among those, condom use was low. Results could be used to improve post-VMMC counseling.

Acceptability of a nipple shield delivery system administering antiviral agents to prevent mother-to-child transmission of HIV through breastfeeding.

BACKGROUND: Breastfeeding is a route of mother-to-child transmission (MTCT) of the human immunodeficiency virus (HIV). The World Health Organization recommends antiretroviral (ARV) prophylaxis as the best method to prevent mother-to-child transmission of HIV (PMTCT) during breastfeeding. The nipple shield delivery system (NSDS) is being developed as an accessible method to deliver ARVs to infants and PMTCT during breastfeeding. The NSDS can potentially circumvent hygiene and storage issues in delivering drugs to infants in low-resource settings. OBJECTIVES: The primary objective was to determine acceptability of the NSDS for PMTCT in Kenya. Secondary objectives included assessing mothers' understanding of MTCT and identifying cultural and implementation issues that might affect NSDS acceptability. METHODS: Eleven focus group discussions were conducted, each group consisting of 7 to 12 participants. Seven focus group discussions consisted of HIV-positive mothers, 2 included grandmothers/mothers-in-law, and 2 included fathers/husbands. Ten in-depth interviews were also conducted with individual maternal/child health care providers. Topics included infant feeding and HIV stigma, as well as safety, effectiveness, and feasibility of the NSDS. Device prototypes were used in discussions. RESULTS: Participants felt that the NSDS could be trusted if validated scientifically and promoted by health care professionals. HIV-related stigma, access, efficacy, and hygiene were identified as important considerations for acceptance. CONCLUSION: The NSDS is a potentially acceptable method of PMTCT during breastfeeding. Further studies are needed to confirm acceptability, safety, and efficacy. For NSDS adoption to PMTCT, strategies will need to be developed to minimize HIV-related stigma and to ensure that continuous hygiene of the device is maintained.

Pregnancy rates after vasectomy: a survey of US urologists.

We surveyed 2000 US urologists using mailed questionnaires. The aim of this survey was to estimate the incidence of pregnancy after vasectomy and to gather information on the surgical methods used. Of 586 responding urologists, 538 reported performing vasectomies, and they reported a total of 177 pregnancies during the preceding 5 years. Ninety pregnancies (51%) were attributed to unprotected intercourse during the immediate post-vasectomy period. The remaining pregnancies were attributed to recanalization or other less common causes of method failure. Based on the number of vasectomies performed by these surgeons, about 1 pregnancy was reported per 1000 vasectomies. This is probably an underestimate of the true rate. The risk of pregnancy was lower following vasectomies by surgeons who performed more than 50 procedures per year.

Safety and acceptability of post-abortal IUD insertion and the importance of counseling.

This nonrandomized observational clinical study evaluated the safety and acceptability of intrauterine device insertion either immediately or 2 weeks after abortion, according to the patient's preference. Participants were 300 women with first-trimester abortions who agreed to immediate or delayed insertion. End points were bleeding patterns, pregnancy, expulsion, perforation, infection and device removal at 2, 6 and 10 weeks after insertion, and acceptance rates before and after counseling procedures were improved. The overall initial acceptance rate was 35.8%, and the actual acceptance rate was 31.7%. After counseling procedures were improved, the initial and actual acceptance rates increased substantially (17.7% vs. 44.3% and 10.2% vs. 42.0%, respectively). Bleeding, expulsion rates and pain did not differ significantly between the immediate and delayed insertion groups after IUD insertion. No pregnancies, perforations or cases of pelvic inflammatory disease were recorded in either group. Immediate post-abortal insertion offers the advantage of being a painless procedure. The quality of counseling is critical to improving acceptance of post-abortion contraception.

Lactational amenorrhea as a method of family planning in Egypt.

Because of the potential importance of the lactational amenorrhea method (LAM) as a family-planning option in Egypt, we analyzed data from the 1995 Egyptian Demographic and Health Survey (EDHS) to study breastfeeding practices, use of contraception, reproductive history and sociodemographic factors for 5504 mothers with children under 3 years. According to the EDHS data, about 80% of Egyptian women breastfed for at least 6 months, and 40% breastfed for 15-18 months. Over half of breastfeeding mothers used no additional contraception. Thirty-six percent of mothers breastfeeding children younger than 6 months who reported using no additional contraception were exclusively breastfeeding and amenorrheic, but only 4% reported relying on breastfeeding for family planning. We also held eight focus group discussions with breastfeeding mothers from urban and rural Upper and Lower Egypt on their use of contraceptive methods, breastfeeding, lactational amenorrhea and LAM. Participants showed strong recognition of the contraceptive effects of breastfeeding but differed widely in their understanding of lactational infecundability and knowledge of LAM as a method. These results suggest that LAM would be widely acceptable to Egyptian women, but that an educational program about the method is needed.

Effect of diltiazem and methylene blue on human sperm motility, viability and cervical mucus penetration: potential use as vas irrigants at the time of vasectomy.

The purpose of this study was to identify compounds that could potentially be useful for vas irrigation at the time of vasectomy. We studied the in vitro effects of a group of membrane-active and ion-channel blocking agents on human sperm motility, viability and cervical mucus penetration. Diltiazem, an anti-arrhythmic drug, and methylene blue, an agent commonly used in vasography, showed the most promising effects with marked reduction of sperm motility and cervical mucus penetration after incubation with sperm for a short period of 15 min. Diltiazem was more effective than methylene blue in inhibiting the motility and viability of sperm. Furthermore, unlike methylene blue, diltiazem significantly compromised sperm viability. Other compounds studied, such as lidocaine, nicardipine and Neosporin((R)), showed only partial inhibitory activity. Based on the data reported herein, both diltiazem and methylene blue appear to be suitable candidates to be developed for vas irrigation at the time of vasectomy.

Vasectomy effectiveness in Nepal: a retrospective study.

The main purpose of this retrospective, cross-sectional study was to evaluate the effectiveness of vasectomy in an ongoing public sector program in Nepal. We evaluated semen samples from men who had previously had a vasectomy, and asked about the occurrence of pregnancies in the men's partners. In addition, the surgeons who performed the vasectomies completed a questionnaire about their techniques. A two-stage stratified sampling procedure was used to select 1263 men from among over 30,000 men, who had previously undergone a no-scalpel vasectomy, mostly by ligation and excision, in 32 districts between July 1996 and June 1999. Semen samples were preserved and analyzed at a central laboratory. A US andrology laboratory validated the lab results. Twenty-three men (2.3%, 95% confidence interval [CI] 1.1-3.6) had >/=500,000 sperm/mL in their semen. Fifteen of those men reported pregnancies conceived after their vasectomy. In addition, six men with azoospermia reported pregnancies for which conception occurred within 3 months after vasectomy. Eleven men with azoospermia reported pregnancies for which conception occurred more than 3 months after vasectomy. Reported pregnancy was more likely in younger partners. The life table pregnancy rates for all men interviewed were 0.7 (95% CI 0.2-1.1), 1.7 (95% CI 1.4-2.1) and 4.2% (95% CI 3.2-5.2) at 3, 12 and 36 months, respectively. In low-resource, programmatic settings, vasectomy failure rates may be higher than commonly cited rates, especially in younger populations. Additional research is needed to determine if other occlusion techniques could reduce failure rates. Counseling on vasectomy should always convey the possibility of failure and partner pregnancy.

Recent research on vasectomy techniques.

Vasectomy is a commonly used, highly effective method for the control of fertility in the human male. It is almost always performed as an outpatient procedure, is safer than tubal occlusion and has few side effects. The number of people relying on vasectomy as a method of contraception varies widely from country to country. Though vasectomy is highly effective, failures may occur due to re-canalization of the vas, surgical error, anatomical variants or failure of contraception during the post-operative waiting period. One of the disadvantages of this technique is that sperm are present in the posterior end of the vas following surgery and hence patients have to use alternative methods of contraception for a waiting period of 12 weeks to 15 weeks before relying on a vasectomy for contraception. This review summarizes recent research on vasectomy conducted by Family Health International, USA.

Effectiveness of vasectomy using cautery.

BACKGROUND: Little evidence supports the use of any one vas occlusion method. Data from a number of studies now suggest that there are differences in effectiveness among different occlusion methods. The main objectives of this study were to estimate the effectiveness of vasectomy by cautery and to describe the trends in sperm counts after cautery vasectomy. Other objectives were to estimate time and number of ejaculations to success and to determine the predictive value of success at 12 weeks for final status at 24 weeks. METHODS: A prospective, non-comparative observational study was conducted between November 2001 and June 2002 at 4 centers in Brazil, Canada, the UK, and the US. Four hundred men who chose vasectomy were enrolled and followed for 6 months. Sites used their usual cautery vasectomy technique. Earlier and more frequent than normal semen analyses (2, 5, 8, 12, 16, 20, and 24 weeks after vasectomy) were performed. Planned outcomes included effectiveness (early failure based on semen analysis), trends in sperm counts, time and number of ejaculations to success, predictive value of success at 12 weeks for the outcome at 24 weeks, and safety evaluation. RESULTS: A total of 364 (91%) participants completed follow-up. The overall failure rate based on semen analysis was 0.8% (95% confidence interval 0.2, 2.3). By 12 weeks 96.4% of participants showed azoospermia or severe oligozoospermia (< 100,000 sperm/mL). The predictive value of a single severely oligozoospermia sample at 12 weeks for vasectomy success at the end of the study was 99.7%. One serious unrelated adverse event and no pregnancies were reported. CONCLUSION: Cautery is a very effective method for occluding the vas. Failure based on semen analysis is rare. In settings where semen analysis is not practical, using 12 weeks as a guideline for when men can rely on their vasectomy should lessen the risk of failure compared to using a guideline of 20 ejaculations after vasectomy.

Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia.

BACKGROUND: Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS: We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18-54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35-42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. RESULTS: We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35-42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. CONCLUSIONS: The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.