Testosterone supplementation does not worsen lower urinary tract symptoms.

PURPOSE: Testosterone replacement therapy is commonly used to treat men with hypogonadism. However, there has been caution in using testosterone replacement therapy in men with moderate to severe lower urinary tract symptoms for fear of worsening the symptoms. In this study we examine the effect of testosterone replacement therapy on lower urinary tract symptoms in hypogonadal men. MATERIALS AND METHODS: We retrospectively reviewed our outpatient database and identified patients with a diagnosis of hypogonadism who received testosterone replacement therapy from 2002 to 2012. Lower urinary tract symptoms were assessed using the AUASI (American Urological Association symptom index) before and after testosterone replacement therapy. Testosterone and prostate specific antigen were also continuously measured, and all patients were closely monitored for side effects of testosterone replacement therapy. Patients who had progression of lower urinary tract symptoms to the point of requiring surgery were included in the study. RESULTS: We identified 120 hypogonadal men who received testosterone replacement therapy, the majority of whom had topical therapy or a combination of topical and pellet based therapy (57.5% and 20.8%, respectively). Mean baseline AUASI (±SD) was 10.8 (±7.8) and mean duration of testosterone replacement therapy was 692 days (±773). Mean change in AUASI was -1.07 (±6.06). Mean baseline prostate specific antigen was 1.6 ng/dl (±1.9) and mean change in prostate specific antigen was 0.44 (±2.2). Of the patients 8.1% had a baseline prostate specific antigen greater than 4.0 ng/dl, and these patients had greater improvement in AUASI than those with a baseline prostate specific antigen less than 4.0 ng/dl (-1.9 vs -1.0, p not significant). Overall 45.8% of patients had a less than 3-point change in AUASI in either direction. Of the 120 patients 38 (31.7%) had improvement in AUASI 3 or more points while 27 (22.5%) had worsening of AUASI 3 or more points. Patients with an improved AUASI had a mean prostate specific antigen change of 0.3 (±3.4), while those who had worsening of AUASI had a mean prostate specific antigen change of 0.7 (±2.2) (p not significant). Approximately 9 of 120 (7.5%) of these men initiated new medications for lower urinary tract symptoms during the course of the study. There was no significant change in AUASI compared to patients without any use of lower urinary tract symptoms medications. In addition, 4 (3.3%) patients had progression of lower urinary tract symptoms and required transurethral resection of the prostate. CONCLUSIONS: We demonstrate that initiating testosterone replacement therapy in hypogonadal men involves a low risk of worsening lower urinary tract symptoms. In fact, many men experience symptom improvement while changes in prostate specific antigen appear minor. Future research should focus on larger patient population studies to further examine this relationship.

Synchronous Testicular Sperm Extraction in the Setting of Bladder Exstrophy.

Bladder exstrophy (BE) is a devastating congenital abnormality of the urinary tract in which infants are born with the urinary bladder extruded through their abdominal wall, a urethra that is open dorsally, and significant secondary abnormalities of the genitalia. We present a male patient with BE who suffered from infertility and after a long course of failed attempts with assisted reproductive technology ultimately benefitted from a synchronous testicular sperm extraction. We review the literature surrounding assisted reproductive techniques in the setting of bladder exstrophy and comment on innovative technologies that may benefit this population.

An assessment tool for computer-assisted semen analysis (CASA) algorithms.

Computer-Assisted Semen Analysis (CASA) enables reliable analysis of semen images, and is designed to process large number of images with high consistency, accuracy, and repeatability. Design and testing of CASA algorithms can be accelerated greatly if reliable simulations of semen images under a variety of conditions and sample quality modes are available. Using life-like simulation of semen images can quantify the performance of existing and proposed CASA algorithms, since the parameters of the simulated image are known and controllable. We present simulation models for sperm cell image and swimming modes observed in real 2D (top-down) images of sperm cells in laboratory specimen. The models simulate human sperm using four (4) types of swimming, namely linear mean, circular, hyperactive, and immotile (or dead). The simulation models are used in studying algorithms for segmentation, localization, and tracking of sperm cells. Several segmentation and localization algorithms were tested under varying levels of noise, and then compared using precision, recall, and the optimal subpattern assignment (OSPA) metric. Images of real human semen sample were used to validate the segmentation and localization observations obtained from simulations. An example is given of sperm cell tracking on simulated semen images of cells using the different tracking algorithms (nearest neighbor (NN), global nearest neighbor (GNN), probabilistic data association filter (PDAF), and joint probabilistic data association filter (JPDAF)). Tracking performance was evaluated through multi-object tracking precision (MOTP) and multi-object tracking accuracy (MOTA). Simulation models enable objective assessments of semen image processing algorithms. We demonstrate the use of a new simulation tool to assess and compare segmentation, localization, and tracking methods. The simulation software allows testing along a large spectrum of parameter values that control the appearance and behavior of simulated semen images. Users can generate scenarios of different characteristics and assess the effectiveness of different CASA algorithms in these environments. The simulation was used to assess and compare algorithms for segmentation and tracking of sperm cells in semen images.

Poor reproducibility of percentage of normally shaped sperm using the World Health Organization Fifth Edition strict grading criteria.

Objective: To determine the reproducibility of the World Health Organization Fifth Edition (WHO5) strict grading methodology by comparing the percentage of morphologically normal sperm (PNS) recorded by the core laboratory with results obtained at the fertility centers participating in a multisite clinical trial. Design: Secondary cohort analysis of data from the Males, Antioxidants, and Infertility trial. Setting: Fertility centers. Patients: Semen values of 171 men participating in a multicenter, double-blind, randomized, placebo-controlled trial evaluating the effect of antioxidants on male fertility. Interventions: Not applicable. Main Outcome Measures: Strict morphology expressed as PNS as determined at each fertility center and the core central laboratory for the same semen sample. Results: No correlation was found in the PNS values for the same semen sample between the core laboratory and fertility center laboratories either as a group or by individual site. Interobserver agreement was similarly low (κ = 0.05 and 0.15) between the core and fertility laboratories as a group for strict morphology, categorized by the WHO5 lower reference limits of 4% and 0, respectively. Moderate agreement was found between the core and 2 individual fertility laboratories for the cutoff value of 0 (κ = 0.42 and 0.57). The remainder of the comparisons demonstrated poor to fair agreement. Conclusions: Strict morphology grading using the WHO5 methodology demonstrated overall poor reproducibility among a cohort of experienced fertility laboratories. This lack of correlation and agreement in the PNS values calls into question the reproducibility, and thereby the potential applicability, of sperm strict morphology testing.

Male vitamin D status and male factor infertility.

OBJECTIVE: To determine the association between vitamin D levels in the male partner and fertility outcomes in couples with mild male factor infertility. DESIGN: Secondary analysis of a randomized, controlled trial. SETTING: Nine fertility centers in the United States. PATIENT(S): Men (n = 154) with sperm concentration between 5 and 15 million/mL, motility ≤40%, or normal morphology ≤4% were eligible. Female partners were ovulatory, ≤40 years old, and had documented tubal patency. INTERVENTION(S): Men provided semen and blood at baseline for semen analysis and 25-hydroxyvitamin D (25(OH)D) levels. They were randomly assigned to receive a vitamin formulation including vitamin D 2,000 IU daily or placebo for up to 6 months. Couples attempted to conceive naturally during the first 3 months and with clomiphene citrate with intrauterine insemination of the female partner in months 4 through 6. MAIN OUTCOME MEASURE(S): Primary: sperm concentration, motility, morphology, and DNA fragmentation at baseline. Secondary: cumulative pregnancy, miscarriage, and live birth rates. RESULT(S): Semen parameters and sperm DNA fragmentation were not statistically significantly different between men with vitamin D deficiency and men with 25(OH)D levels ≥20 ng/mL. In addition, clinical pregnancy and live birth rates were similar. Male 25(OH)D level <20 ng/mL was associated with a higher rate of pregnancy loss (adjusted odds ratio 9.0; 95% confidence interval 1.3 to 61.3). CONCLUSION(S): Vitamin D deficiency in the male partner did not significantly impact semen parameters or treatment outcomes. Further study is warranted to better characterize the rate of miscarriage in couples with male vitamin D deficiency.

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.

[Adult male circumcision for military men: history and future].

Adult male circumcision (MC) has been shown to reduce the transmission of HPV, HSV, and HIV significantly during vaginal intercourse. However, the benefits of adult MC for men in military service have been poorly documented. Soldiers in war time have additional challenges in maintaining good penile hygiene, rendering uncircumcised men vulnerable to inflammation and infection; these maladies not only negatively impact these individuals, but also undermine the overall military strength. Adult MC can provide some long-term benefits for these military service men. Many African countries have already taken a special interest in adult MC for their military forces, resulting in increased numbers of these surgeries among this special population of men. In this review, we discuss the history of adult MC in the military along with the current trends and economic significance.

The effect of antioxidants on male factor infertility: the Males, Antioxidants, and Infertility (MOXI) randomized clinical trial.

OBJECTIVE: To determine whether antioxidants improve male fertility, as measured by semen parameters and DNA fragmentation at 3 months and pregnancy resulting in live birth after up to 6 months of treatment, among couples with male factor infertility. DESIGN: Multicenter, double-blind, randomized, placebo-controlled trial with an internal pilot study. SETTING: Nine fertility centers in the United States from December 2015 to December 2018. PATIENT(S): Men (N = 174) with sperm concentration ≤15 million/mL, motility ≤40%, normal morphology ≤4%, or DNA fragmentation >25%, and female partners who were ovulatory, ≤40 years old, and had documented tubal patency. INTERVENTION(S): Males randomly assigned to receive an antioxidant formulation (n = 85) containing 500 mg of vitamin C, 400 mg of vitamin E, 0.20 mg of selenium, 1,000 mg of l-carnitine, 20 mg of zinc, 1,000 µg of folic acid, 10 mg of lycopene daily, or placebo (n = 86). Treatment lasted for a minimum of 3 months and maximum of 6 months, and couples attempted to conceive naturally during the first 3 months and with clomiphene citrate with intrauterine insemination of the female partner in months 4 through 6. MAIN OUTCOME MEASURE(S): Primary outcome was live birth; secondary outcomes included pregnancy within 6 months of treatment. For the internal pilot, the primary outcomes were semen parameters and sperm DNA fragmentation index after 3 months of treatment. RESULT(S): In the Males, Antioxidants, and Infertility (MOXI) study, after 3 months of treatment, the change in sperm concentration differed between the antioxidant group (median -4.0 [interquartile range-12.0, 5.7] million/mL) and placebo group (+2.4 [-9.0, 15.5] million/mL). However, there were no statistically significant differences between the two groups for changes in sperm morphology, motility, or DNA fragmentation. Among the 66 oligospermic men at randomization, sperm concentration did not differ at 3 months between the antioxidant and control groups: 8.5 (4.8, 15.0) million/mL versus 15.0 (6.0, 24.0) million/mL. Of the 75 asthenospermic men, motility did not differ at 3 months: 34% ± 16.3% versus 36.4% ± 15.8%. Among the 44 men with high DNA fragmentation, DNA fragmentation did not differ at 3 months: 29.5% (21.6%, 36.5%) versus 28.0% (20.6%, 36.4%). In the entire cohort, cumulative live birth did not differ at 6 months between the antioxidant and placebo groups: 15% versus 24%. CONCLUSION(S): Antioxidants do not improve semen parameters or DNA integrity among men with male factor infertility. Although limited by sample size, this study suggests that antioxidant treatment of the male partner does not improve in vivo pregnancy or live-birth rates. CLINICAL TRIAL REGISTRATION NUMBER: NCT02421887.

How often do available preoperative risk factors accurately predict the risk assessed after surgery for localized prostate cancer?

OBJECTIVE: To describe how frequently new information obtained at surgery translates into a substantial change in the risk of recurrence for patients with localized prostate cancer, and to determine what factors contribute to this increase in risk, as the preferred therapy for prostate cancer is often chosen based on available preoperative variables and therefore appropriate decision-making requires an accurate preoperative assessment. PATIENTS AND METHODS: Using the Columbia Comprehensive Clinical Database of Urologic Oncology, we retrospectively analysed 3460 men who had radical prostatectomy (RP) for prostate cancer from 1988 to 2006. Kattan nomograms were used to calculate the 5-year progression-free probabilities before and after RP. The difference between these nomogram scores was used to divide patients into three groups, those with a decrease in the probability of disease-free survival (DFS) of > or =15%, those with an increase in the probability of DFS of > or =15%, and those with an absolute change of <15%. RESULTS: In all, 1804 men with complete data before and after RP were analysed; 1220 (68.4%) had no significant change in nomogram score, 238 (13.3%) had a significant increase and 327 (18.3%) had a significant decrease in the probability of recurrence. Those patients with an increased probability of recurrence had a greater proportion of patients with pathological Gleason sum of > or =8, higher rates of extraprostatic capsular invasion, positive margins, seminal vesical invasion and lymph node involvement (all P < 0.001). CONCLUSION: Accurate risk predictions both before and after RP are central to effective patient counselling and optimal management. Notably, 13.3% of the present patients were faced with a substantial increase of > or =15% in their risk of biochemical failure after pathological variables became available.

Automatic Tracking and Motility Analysis of Human Sperm in Time-Lapse Images.

We present a fully automated multi-sperm tracking algorithm. It has the demonstrated capability to detect and track simultaneously hundreds of sperm cells in recorded videos while accurately measuring motility parameters over time and with minimal operator intervention. Algorithms of this kind may help in associating dynamic swimming parameters of human sperm cells with fertility and fertilization rates. Specifically, we offer an image processing method, based on radar tracking algorithms, that detects and tracks automatically the swimming paths of human sperm cells in timelapse microscopy image sequences of the kind that is analyzed by fertility clinics. Adapting the well-known joint probabilistic data association filter (JPDAF), we automatically tracked hundreds of human sperm simultaneously and measured their dynamic swimming parameters over time. Unlike existing CASA instruments, our algorithm has the capability to track sperm swimming in close proximity to each other and during apparent cell-to-cell collisions. Collecting continuously parameters for each sperm tracked without sample dilution (currently impossible using standard CASA systems) provides an opportunity to compare such data with standard fertility rates. The use of our algorithm thus has the potential to free the clinician from having to rely on elaborate motility measurements obtained manually by technicians, speed up semen processing, and provide medical practitioners and researchers with more useful data than are currently available.

Validation of the Patient Global Impression of Improvement for Penile Prosthesis.

BACKGROUND: No consensus on the preferred means of evaluating patients after surgical placement of an inflatable penile prosthesis (IPP) currently exists. Many self-assessment questionnaires are available, but none specifically targets patients with IPPs. The purpose of this study was to assess the construct validity of the Patient Global Impression of Improvement (PGI-I) for evaluating patient satisfaction after placement of an IPP. METHODS: We conducted a multicenter prospective trial and enrolled patients who elected to have a 3-piece IPP surgically implanted. Postoperatively, patients completed the Sexual Health Inventory for Men (SHIM), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and PGI-I at 3, 6, and 12 months. The Pearson correlation coefficient (PCC) was used to compare scores over time. RESULTS: Fifty-six patients were enrolled, and complete data were available for 39 patients. At 3 months, the PGI-I correlated with the EDITS (PCC=0.83, P<0.01) and with the SHIM (PCC=0.73, P<0.01). At 6 months, the PGI-I correlated with the EDITS (PCC=0.74, P<0.01). At 6 months, the PCC between the PGI-I and the SHIM was 0.41 (P<0.05). At 12 months, the PCC between the PGI-I and the EDITS was 0.83 (P<0.01), and the PCC between the PGI-I and the SHIM was 0.61 (P<0.01). CONCLUSIONS: Overall, the PGI-I appears to correlate with both the SHIM and EDITS and is a valid evaluation tool for use with patients after IPP placement.

PDE-5 inhibitors: current status and future trends.

Phosphodiesterase-5 (PDE-5) inhibitors are a well-established, first-line therapy for erectile dysfunction (ED). Extensive clinical trials and clinical experience established the highly significant efficacy and the safety of this class of drugs in the treatment of ED.Furthermore, the efficacy of PDE-5 inhibitors has been established in men with ED with a broad range of etiologies and comorbidities. The future of PDE-5 inhibitors includes the expansion of indications such as the treatment of pulmonary hypertension and the potential of treatment of symptomatic BPH.

Testosterone replacement therapy and the internet: an assessment of providers' health-related web site information content.

OBJECTIVE: To compare how providers of testosterone replacement therapy (TRT) in large metropolitan cities promote androgen replacement on their patient-oriented Web sites. MATERIALS AND METHODS: TRT provider Web sites were identified using Google search and the terms "Testosterone replacement" and the name of the 5 most populous US cities. These Web sites were assessed for (1) type or specialty of medical provider, (2) discussion of the benefits and risks of TRT, and (3) industry affiliations. RESULTS: In total, 75 Web sites were evaluated. Twenty-seven of the 75 clinics (36%) were directed by nonphysicians, 35 (47%) were overseen by nonurology or nonendocrine physicians, and only 13 (17%) were specialist managed. Fourteen of 75 (18.6%) Web sites disclosed industry relationships. Ninety-five percent of Web sites promoted the benefits of TRT including improved sex drive, cognitive improvement, increased muscle strength, and/or improved energy. Only 20 of 75 Web sites (26.6%) described any side effect of TRT. Web sites directed by specialists were twice as likely to discuss risks of TRT compared with nonspecialist providers (41% vs 20%; odds ratio = 2.77; P <.01). Nine of 75 (12%) of all Web sites actually refuted that TRT was associated with significant side effects. CONCLUSION: Urologists and endocrinologists are in the minority of providers promoting TRT on the Internet. Specialists are more likely to discuss risks associated with TRT although the majority of surveyed Web sites that promote TRT do not mention treatment risks. There is substantial variability in quality and quantity of information on provider Web sites, which may contribute to misinformation regarding this prevalent health issue.

The men's health center: Disparities in gender specific health services among the top 50 "best hospitals" in America.

OBJECTIVE: Gender-specific integrated health services have long existed in the arena of women's health care, but men's health centers (MHCs) have only recently emerged as a novel practice model. Here, we seek to evaluate the prevalence and format of MHCs found in the leading academic medical centers in the United States. METHODS: The US News & World Report's Top 50 Ranked Hospitals for Urology was used as our cohort. Data were gathered on the presence of MHCs and types of providers and conditions treated. An equivalent search was performed for women's health centers (WHCs). RESULTS: Sixteen of 50 (32%) promoted some type of MHC, compared to 49 of 50 (98%) offering a WHC. Eight of the top 15 ranked institutions (53%) had an MHC compared to eight of 35 (23%) remaining programs. Six of 16 MHCs incorporated providers from a variety of medical disciplines, including urologists, internists, endocrinologists, cardiologists, and psychologists, while another six of 16 MHCs were staffed solely by urologists. Eight of 16 provided services for exclusively urologic issues, four of 16 offered additional services in treatment of other medical conditions, and four of 16 did not specify. CONCLUSION: A considerable disparity exists between the prevalence of gender-specific health services, with WHCs being much more numerous than MHCs. All but one leading institution had WHCs compared to less than one-third having MHCs. Our findings also highlight the heterogeneous nature of men's health programs, as they exhibit great variability in program type and focus, yet are all being marketed under the "Men's Health" banner.

The varicocele.

Varicoceles are an abnormal dilation of the pampiniform plexus of veins within the scrotum. Varicoceles are highly prevalent and can result in a myriad of deleterious effects on male reproduction. Numerous therapeutic options are available for correcting varicoceles, including surgical varicocelectomy and radiographic venous embolization. Varicocele correction is a more cost-effective therapeutic modality than both intrauterine insemination (IUI) and in vitro fertilization (IVF) for affected couples. In summary, varicoceles contribute significantly to male reproductive pathology, and varicocele correction is an important option for both clinicians and patients to consider in this era of assisted reproductive techniques.

Current practices in fertility preservation in male cancer patients.

The incidence of a cancer diagnosis in children and young adolescents is increasing. With better treatments, the number of young cancer survivors living through reproductive age is increasing. Fertility preservation of these men and women has become essential and needs to be discussed prior to the start of cancer treatment. Here we review the current guidelines for male oncofertility patients and highlight some of the important gonadotoxic effects of chemotherapy, radiotherapy and surgery. Options for fertility preservation are also discussed along with resources that should be made available to all patients.

Penile fracture: outcomes of early surgical intervention.

OBJECTIVE: To report a series of penile fractures, describing preoperative evaluation, surgical repair, and long-term outcomes. PATIENTS AND METHODS: Medical records from Northwestern Memorial Hospital and Oregon Health & Science University from 2002 to 2011 were reviewed. Clinical presentation, preoperative evaluation, time from injury, mechanism and site of injury, and presence of urethral injury were assessed. Outcomes including erectile dysfunction, penile curvature, and voiding symptoms were evaluated using International Prostate Symptom Score and International Index of Erectile Function scores. RESULTS: Twenty-nine patients with 30 separate episodes of penile fractures presenting to the emergency room were identified. Mean patient age was 43 ± 9.6 years. The time from presentation to the initiation of surgery was 5.5 ± 4.4 hours. Mechanism of injury was intercourse in 26 of 30 fractures with the remaining attributed to masturbation or "rolling over." Immediate surgical repair was offered to all patients. Twenty-seven patients underwent surgery. Urethral injury was noted in 5 of the 27. The site of fracture was at the proximal shaft in 11, mid shaft in 12, and distal shaft in 4 patients. The mean follow-up period was 14.3 ± 15.8 weeks. Nine patients reported new mild erectile dysfunction or penile curvature. One patient reported new irritative voiding symptoms. CONCLUSION: The most common mechanism of penile fracture was from sexual intercourse, and frequent concomitant urethral injuries were observed. The frequency of concomitant urethral injury was higher than in previous studies. Although we observed high incidence of erectile dysfunction or penile curvature with early surgical repair, we retain it as the favored approach.

Randomized trial of the Shang Ring for adult male circumcision with removal at one to three weeks: delayed removal leads to detachment.

OBJECTIVES: To assess healing with Shang Ring removal at different prespecified times; whether spontaneous detachment occurs with delayed removal; problems, complaints, and acceptability of wearing the device; satisfaction among participants; and acceptability of the procedure among providers. METHODS: Fifty HIV-negative men underwent a Shang Ring circumcision in Kenya. Men were randomly assigned for device removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Follow-up visits were at 7, 14, 21, 28, and 42 days after circumcision and 2 days after removal. RESULTS: Circumcision and device removal were conducted without significant problems. Mean times for circumcision and device removal were 6.5 (SD = 2.4) and 2.5 (SD = 0.8) minutes, respectively. Complete detachment of the device occurred in 22 (66.7%) men who wore it more than 7 days. Seven men (14.0%) with partial detachments requested removal 8-14 days postcircumcision due to pain/discomfort. Healing progressed normally in all participants; cumulative probabilities of complete healing were similar across groups. No severe or serious adverse events occurred. Acceptability among participants was high. Providers reported that Shang Ring circumcision was "very easy" compared with the forceps-guided procedure. CONCLUSION: The Shang Ring is safe and easy to use according to label instructions (7 day removal). Detachments occurred without significant problems, although some men requested removal of partially detached rings. Removal time had little effect on healing. These data help allay concerns about men not returning for ring removal and expand the evidence base suggesting the Shang Ring could facilitate rapid male circumcision rollout in sub-Saharan Africa.

The Shang Ring device for adult male circumcision: a proof of concept study in Kenya.

OBJECTIVE: To assess safety, preliminary efficacy, and acceptability of the Shang Ring, a novel disposable device for adult male circumcision in Kenya. METHODS: Forty HIV-negative men were recruited in Homa Bay, Kenya. Circumcisions were performed by a trained physician or nurse working with 1 assistant. Follow-up was conducted at 2, 7, 9, 14, 21, 28, 35, and 42 days after circumcision. Rings were removed on day 7. Pain was assessed using a visual analog scale (VAS) (0 = no pain, 10 = worst possible). Men were interviewed at enrollment and on days 7 and 42. RESULTS: All 40 procedures were completed successfully. Mean procedure and device removal times were 4.8 (SD ± 2.0) and 3.9 (SD ± 2.6) minutes, respectively. There were 6 mild adverse events, including 3 penile skin injuries, 2 cases of edema, and 1 infection; all resolved with conservative management. In addition, there were 3 partial ring detachments between days 2-7. None required treatment or early ring removal. Erections with the ring were well tolerated, with a mean pain score of 3.5 (SD ± 2.3). By day 2, 80% of men were back to work. At 42 days, all participants were very satisfied with their circumcision and would recommend the procedure to others. CONCLUSIONS: Our results demonstrate that the Shang Ring is safe for further study in Africa. Acceptability of the Shang Ring among participants was excellent. With short procedure times, less surgical skill required, and the ease with which it can be used by nonphysicians, the Shang Ring could facilitate rapid roll-out of male circumcision in sub-Saharan Africa.

The ShangRing device for simplified adult circumcision.

Adult male circumcision reduces HIV transmission through vaginal intercourse and is being promoted in areas where HIV is widespread. Conventional surgical circumcision involves suturing and thus requires practitioners with surgical skills. It is also associated with complications, including bleeding and infection, especially in resource-poor settings. The ShangRing (Wuhu Snnda Medical Treatment Appliance Technology Co. Ltd, Wuhu City, China) has been used to perform thousands of circumcisions in adult men, principally in China. It consists of two concentric plastic rings that sandwich the foreskin of the penis, allowing circumcision without stitches or notable bleeding. As well as substantially reduced operative times, ShangRing adult male circumcision is associated with a low complication rate, and the technique can easily be taught to both physician and nonphysician personnel. The simple technique and successful outcomes associated with the ShangRing procedure mean that the device could enable standardization of adult male circumcision, helping HIV prevention efforts throughout the developing world.