All circumcisions were completed without complications. Forty-four (88.0%) men completed 6 weeks follow-up, 1 (2.0%) was discontinued due to geographic relocation, and 5 (10.0%) were lost to follow-up, none before device removal or spontaneous detachment (Fig. 1).
In 9 (18.0%) men, the foreskin was too tight to evert over the inner ring and it was necessary to make a small slit (median 1.5cm) in the foreskin before circumcision. Ten device sizes were used; 80% were between 31-mm to 35-mm diameter (40 mm—1 man, 39 mm—2 men, 37 mm—2 men, 36 mm—2 men, 35 mm—6 men, 34 mm—6 men, 33 mm—8 men, 32 mm—12 men, 31 mm—8 men, and 30 mm—3 men). The mean circumcision time, after anesthesia onset, was 6.5 (SD = 2.4) minutes. The mean postoperative pain score (1 hour after start of the procedure) was 4.5 (SD = 2.0).
Seventeen men had the device removed on day 7, including the 15 participants randomized to the 7-day group, 1 participant from the 14-day group whose device was mistakenly removed, and 1 participant from the 21-day group who requested device removal (Fig. 2). Of the 28 (56.0%) participants overall, who had the device removed, 21 were on the intended removal day and 7 were removed early at the participant's request due to pain/discomfort from the partially detached ring contacting the healing wound (4 in the 14-day group and 3 in the 21-day group) (Fig. 2).
Removals were uneventful; mean time was 2.5 (SD = 0.8) minutes. The mean score reported for highest degree of pain during removal was 3.8 (SD = 2.3), which decreased to 1.0 (SD = 1.3) approximately 10 minutes after removal. On the day of removal, partial detachment was seen in half (14 of 28) of the men. Among men still wearing the device, the cumulative probability of at least partial detachment on days 7, 14, and 21 was 26.0%, 94.1%, and 100.0%, respectively.
Complete detachment occurred in 22 (66.7%) men who wore the device more than 7 days; most (18 of 22) between days 10–16 postcircumcision (Fig. 2). Some participants returned to the clinic with the device completely off their penis (Fig. 3A). For others, the device slid down the penile shaft and was removed by a provider because it was not possible to easily slide it off due to edema or potential to damage the healing wound (Fig. 3B). Cumulative probabilities of complete spontaneous detachment at 7, 14, and 21 days were 0.0%, 56.1%, and 93.7%, respectively.
Complete healing was observed in 46 of 50 (92.0%) men. Two men were lost to follow-up before complete healing: 1 had removal on day 7 as scheduled and was followed through 28 days; the other experienced complete detachment on day 10 and was followed through 21 days. Two men were not completely healed by 42 days but did not return for additional follow-up as follows: 1 had removal on day 14 as scheduled and experienced a moderate wound disruption AE (below); the other, randomized to 21-day removal, requested removal on day 8, and experienced no subsequent events.
The earliest time point at which participants were observed to have healed completely was 21 days. Cumulative probabilities of complete healing were similar across randomization groups (P = 0.86; Table 2). Although not significant, there was a tendency towards faster healing among men whose device was removed or detached at approximately 14 days (P = 0.13; Table 2). Complete healing also tended to be sooner in men whose device was removed or spontaneously detached after 7 days compared with those whose ring was removed on day 7, although differences were not significant (P = 0.18). For example, cumulative probabilities at 21 and 28 days were 18.2% and 74.8% versus 11.8% and 52.9% in those men whose device was left on beyond 7 days compared with those whose device was removed at 7 days, respectively.
There were no severe and 6 moderate AEs (4 of the 6 were among men who requested early ring removal). One man experienced excessive pain immediately post-op. He was treated with an oral analgesic, additional local anesthetic, and eventually an intramuscular injection of a nonsteroidal anti-inflammatory before discharge from the clinic. Two other pain-related AEs were reported, both by men in the 14-day group and due to pain caused by rubbing of the partially detached ring against the healing wound. Devices were removed at the participant's request; 1 on day 7 and 1 on day 8.
The other 3 were wound disruptions that met the revised definition of moderate dehiscence/disruption (Methods). Moderate wound disruption was noted in 1 participant after his scheduled device removal on day 14. The other 2 men were in the 21-day group; 1 with moderate disruption on day 8 and the other on day 14. Both requested device removal because of pain caused by rubbing of the partially detached ring against the healing wound. All 3 were managed conservatively, that is, without antibiotics or surgical intervention.
After independently reviewing participant's photographs, 2 PIs (D.S., M.B.) identified 9 cases of small penile shaft cutaneous injuries. Site investigators had classified 4 as mild AEs and 5 as within normal limits. Of the 9, 3 were very similar to cases seen previously in Kenya.10
Irrespective of AEs, removal day, spontaneous detachment, or request for early removal, men with documented complete healing healed without problems and with excellent cosmesis. At the 6-week follow-up the majority (38 of 43) were “very satisfied” with the appearance of their circumcised penis. The remainder were “somewhat satisfied” (4 of 43) or “somewhat dissatisfied” (1 of 43). Although the numbers are small, men who were not “very satisfied” were in the 14 day (3 men) and 21 day (2 men) groups.
The maximum scores, over all visits before removal or detachment, for interference with various activities from pain associated with wearing the device were (mean, SD): walking 1.0 (2.3), sleeping 2.0 (2.5), working 1.1 (2.5), and enjoying life 0.9 (2.0). All but 1 man returned to normal work wearing the device. Among men returning to work while wearing the device, all were back to work within 2 days of circumcision (median = 1 day).
When asked at 6 weeks what they liked about the circumcision, participants most commonly mentioned that the procedure was quick (39 of 43), they were happy with the appearance of their penis (20 of 43), they experienced less pain than expected (16 of 43), and stitches were unnecessary (13 of 43). The only commonly (11 of 43) mentioned complaint about the circumcision was pain/discomfort during erections. All men reported experiencing erections while wearing the device. The mean of the maximum pain scores reported by each participant during an erection while wearing the device and after removal/spontaneous detachment were 3.8 (SD = 2.0) and 0.9 (SD = 1.4), respectively. All men who completed the study said they would recommend circumcision to a friend or family member.
All 4 providers reported that Shang Ring circumcision was “very easy” compared with the forceps-guided procedure. However, all said they would not recommend letting men wear the ring until it detached because they perceived it was sometimes too painful.
These results confirm that the Shang Ring is safe and easy to use per label instructions of removal at 7 days. As in previous studies,3–6,10 all circumcisions were completed as planned with no significant problems or intraoperative complications. Mean circumcision time was 6.5 minutes, less than reported for conventional suture circumcision, which ranges from 20 to 40 minutes.6,16,17
We demonstrated that if removal is delayed beyond 7 days, the device will eventually detach without significant problems. There seem to be no serious consequences if removal is delayed or men do not return for removal. Indeed, most men randomized to the 14-day and 21-day groups had spontaneous detachments. Although 7 men in the delayed removal groups requested early removal due to pain/discomfort from the partially detached device rubbing against the healing wound (not pain during erections), there were also 22 men who had complete detachment without seeking early removal. In some men, the device detached from the circumcision site and slipped back onto the penile shaft but was not easily removed due to edema or concern about disrupting the healing wound. In these cases, providers removed the device using standard removal procedures, and thus we could not follow men to document if any problems might occur after the ring slipped onto the penile shaft or if waiting until the device could be slipped off the penis would present any concerns.
Unlike some pediatric circumcision devices that are left to fall off, all adult devices currently described in the literature require removal.17–19 Waiting for the Shang Ring to fall off might be a suitable service delivery strategy in settings where a removal visit may be inconvenient; implementation research would be needed to evaluate larger scale use of this approach, including assessment of outcomes in men whose ring slips back toward the base of the penis rather than falling off. Men could, for example, be told that the device will fall off on its own, most likely within 14–16 days, and that they should return to the clinic if they experience problems or have concerns.
Healing progressed normally in all men, whether the device was removed or detached spontaneously. Device removal at different times postcircumcision had no significant effect on time to complete healing, although there was a suggestion of a trend toward faster healing among men who wore the device more than 7 days. It is possible that the small number of participants did not allow us to detect differences that may have existed.
The need for a small slit in the foreskin in 18.0% of patients to facilitate use of the device was not unexpected, having been reported with the Shang Ring3–6,10 and other adult devices.17–19 Making the slit was not problematic and was painless because the penis was anesthetized.
There were 6 moderate and no severe AEs. Three men from the 14-day and 21-day groups developed moderate wound disruption 8–14 days postcircumcision; healing progressed without intervention. Moderate wound disruption was not seen in men whose device was removed at 7 days in this study or the previous Kenya study,10 suggesting that it may have been caused by wearing the device beyond 7 days.
The other 3 moderate AEs were pain related. One participant experienced significant pain immediately post-op. The other 2 complained of pain during follow-up that met the moderate AE definition (ie, pain requiring bed rest for more than one-half day); neither had infection, significant wound disruption, or other problems. These pain-related AEs might be considered mild under the draft AE definitions recently prepared by PSI and the World Health Organization; moderate pain is defined as “disrupting normal daily activities for 4–7 days.”14
In the previous Kenya study, small cutaneous injuries, thought to be related to a slightly sharp edge on the device, were seen on the penile shaft in 3 participants.10 We saw similar lesions, even though the manufacturer modified the devices we used. Based on the location of these lesions and observations of the providers, we believe they may be caused when a small fold of skin from the penile shaft is pinched between the rings as the outer ring is applied. These lesions were considered mild or within normal limits.
Clearly pain experience or tolerance is individual. Although all 4 providers would not recommend removal beyond 7 days or waiting for the device to detach because of pain they perceived men might experience, most participants reported minimal interference with daily activities due to pain associated with the device, and all but 1 returned to work within 2 days postcircumcision. One-quarter did mention pain or discomfort during erections as a reason they disliked the device. However, the mean of the maximum pain scores men reported experiencing during erections while wearing the device was 3.8, and no participant asked to have the device removed due to pain during erections. Overall, satisfaction with the device and final appearance was excellent, with men reporting they liked the short procedure time and lack of sutures.
Efforts to scale-up adult male circumcision are ongoing in sub-Saharan Africa,2 male circumcision as part of a comprehensive HIV prevention package has been shown to be cost saving,20,21 and recent computer modeling suggests that the benefits to women might be greater than previously thought.22 Interest in devices for adult male circumcision continues to be high in an effort to find techniques that are sutureless, bloodless, and simpler than conventional circumcision. Such a device would address drawbacks of the current techniques that limit the potential for rapid scale-up in resource-limited settings.20,23
Unfortunately, progress has been slow. The TaraKlamp, successfully used in boys,24,25 has been disappointing in men with a high number of AEs, the need to revert to conventional circumcision in some cases, and high refusal rates anecdotally related to size of the device and perceived potential discomfort while wearing it.18 Results were recently published from a randomized study of a template device versus the sleeve method for adult circumcision. Although procedure time was significantly reduced with the device, the procedure was still lengthy (mean 27.5 minutes), and the design of the device does not eliminate the need for suturing.17 More promising is the Alisklamp, a disposable device, which like the Shang Ring is bloodless, sutureless, and a quick procedure. Few complications and good healing were seen in adult men circumcised using the device.19
Although there is now one promising published report on the recently developed PrePex device, suggesting that it can be used without anesthesia, additional data are needed to confirm these results and its safety and acceptability in other populations.26 Further, data are needed to determine what happens if a man does not return for device removal and to quantify the percentage of men for whom the device is not suitable due to a tight foreskin that would prevent insertion of the inner ring.
The Shang Ring, PrePex, and the Alisklamp are best described as “minimally invasive”, and we expect that all could be used by trained nonphysician providers in similar settings. By minimally invasive, we mean no exposure of subcutaneous tissues, and no need for hemostasis or sutures. With all 3 devices, the procedure times are dramatically reduced relative to conventional techniques.
The main limitation of this study was the small sample size, which may have affected our ability to detect differences in healing times or AEs between groups.
Our results contribute to the growing body of evidence that the Shang Ring could facilitate rapid rollout of male circumcision in sub-Saharan Africa given short procedure times, favorable reviews from study participants and providers, and the ease with which it can be used by trained nonphysicians. We found no evidence of serious consequences if men do not return on time for removal, although approximately 20% of men who wore the ring beyond 7 days requested their ring be removed due to some degree of pain/discomfort. Most devices left on longer than 7 days spontaneously detached, falling off the penis in some men, and sliding back toward the base of the penis in others. In the latter group, the device was removed by a provider, and thus we were unable to follow these men to document if waiting until the device could be slipped off the penis would be problematic. Ring removal or detachment at different times seemed to have little effect on healing.
The authors wish to thank the men who volunteered to participate in the study. We also thank the staff of Homa Bay District Hospital and Dr Ojwang' Ayoma, the Medical Superintendant, for their support of the study and male circumcision activities at the site. Additionally, we thank Dr Ayoma for reviewing AEs in his role as independent safety monitor for the study.
The authors are indebted to the following EngenderHealth staff: Daniel Ouma and Carolyne Onyancha for overseeing study activities at the site, obtaining informed consent, and conducting participant interviews; Damaris Otieno for providing male circumcision counseling and HIV testing; Rosemary Were for administrative assistance; and Evans Yanga for transport.
The study could not have been completed without the expert guidance of Stephanie Combes, FHI360 Project Manager and Catherine Hart, FHI360 Research Associate. In addition, the authors thank Lilian Were from FHI360/Nairobi who did an exceptional job as the clinical monitor.
The authors also sincerely thank their Chinese colleagues for their pioneering work on the Shang Ring, especially Dr Yue Cheng from Ningbo First Hospital, Ningbo University School of Medicine; Dr Yifeng Peng from Yijishan Hospital, Wannan Medical College; Dr Yiran Huang, Renji Hospital, Shanghai Jaio Tong University, and Dr Jichuan Zhu, President of the Chinese Society of Andrology Association for their outstanding contributions to use of the Shang Ring as well as assistance in training the physicians and nurses from Africa for our study. The authors also offer their gratitude to Mr Jianzhong Shang, inventor of the Shang Ring, for his generous donation of the Shang Rings and associated supplies used in the study.
1. WHO/UNAIDS. New Data on Male Circumcision and HIV Prevention: Policy and Programme Implications. WHO/UNAIDS Technical Consultation on Male Circumcision and HIV Prevention: Research Implications for Policy and Programming. Montreux, 6–8 March. Conclusions and Recommendations. Geneva, Switzerland: WHO; 2007.
3. Peng YF, Cheng Y, Wang GY, et al.. Clinical application of a new device for minimally invasive circumcision. Asian J Androl. 2008;10:447–454.
4. Cheng Y, Peng YF, Liu YD, et al.. A recommendable standard protocol of adult male circumcision with the Chinese Shang Ring: outcomes of 328 cases in China. Zhonghua Nan Ke Xue. 2009;15:584–592; [in Chinese].
5. Peng YF, Yang BH, Jia C, et al.. Standardized male circumcision with Shang Ring reduces postoperative complications: a report of 351 cases. Zhonghua Nan Ke Xue. 2010;16:963–966; [in Chinese].
6. Li HN, Xu J, Qu LM. Shang Ring circumcision versus conventional surgical procedures: comparison of clinical effectiveness. Zhonghua Nan Ke Xue. 2010;16:325–327; [in Chinese].
7. Auvert B, Taljaard D, Lagarde E, et al.. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005;2:e298.
8. Bailey RC, Moses S, Parker CB, et al.. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007;369:643–656.
9. Gray RH, Kigozi G, Serwadda D, et al.. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369:657–666.
10. Barone MA, Ndede F, Li PS, et al.. The Shang ring device for adult male circumcision: a proof of concept study in Kenya. J Acquir Immune Defic Syndr. 2011;57:E7–E12.
11. World Health Organization. Framework for Clinical Evaluation of Devices for Adult Male Circumcision. Geneva, Switzerland: WHO; February 2011.
12. Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005;14:798–804.
13. Stokes ME, Davis CS, Koch GGCategorical Data Analysis Using the SAS System. 2nd ed. Cary, NC: SAS Institute Inc; 2000.
14. PSI. Adverse Event Action Guide for Male Circumcision. Washington, DC: Draft. PSI; January 2011.
15. Masson P, Barone MA, Li P, et al.. The Shang Ring device for simplified adult circumcision. Nat Rev Urol. 2010;7:638–642.
16. Krieger JN, Bailey RC, Opeya JC, et al.. Adult male circumcision outcomes: experience in a developing country setting. Urol Int. 2007;78:235–240.
17. Decastro B, Gurski J, Peterson A. Adult template circumcision: a prospective, randomized, patient-blinded, comparative study evaluating the safety and efficacy of a novel circumcision device. Urology. 2010;76:810–814.
18. Lagarde E, Taljaard D, Puren A, et al.. High rate of adverse events following circumcision of young male adults with the Tara KLamp technique: a randomised trial in South Africa. S Afr Med J. 2009;99:163–169.
19. Senel FM, Demirelli M, Pekcan H. Mass circumcision with a novel plastic clamp technique. Urology. 2011;78:174–179.
20. Auvert B, Marseille E, Korenromp EL, et al.. Estimating the resources needed and savings anticipated from roll-out of adult male circumcision in Sub-Saharan Africa. PLoS One. 2008;3:e2679.
21. Uthman OA, Popoola TA, Yahaya I, et al.. The cost-utility analysis of adult male circumcision for prevention of heterosexual acquisition of HIV in men in sub-Saharan Africa: a probabilistic decision model. Value Health. 2011;14:70–79.
22. Hallett TB, Alsallaq RA, Baeten JM, et al.. Will circumcision provide even more protection from HIV to women and men? New estimates of the population impact of circumcision interventions. Sex Transm Infect. 2011;87:88–93.
23. Peltzer K, Niang CI, Muula AS, et al.. Male circumcision, gender and HIV prevention in sub-Saharan Africa: a (social science) research agenda. SAHARA J. 2007;4:658–667.
24. Schmitz RF, Abu Bakar MH, Omar ZH, et al.. Results of group-circumcision of Muslim boys in Malaysia with a new type of disposable clamp. Trop Doct. 2001;31:152–154.
25. Schmitz RF, Schulpen TW, Redjopawiro MS, et al.. Religious circumcision under local anaesthesia with a new disposable clamp. BJU Int. 2001;88:581–585.
26. Bitega JP, Ngeruka ML, Hategekimana T, et al.. Safety and efficacy of the PrePex Device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings. J Acquir Immune Defic Syndr. 2011;58:E127–E134.
Keywords:© 2012 Lippincott Williams & Wilkins, Inc.
Shang Ring; circumcision devices; adult male circumcision; wound healing