Date Published: August 14, 2019
Publisher: Public Library of Science
Author(s): Quentin Awori, Philip S. Li, Richard K. Lee, Daniel Ouma, Millicent Oundo, Mukhaye Barasa, Nereah Obura, David Mwamkita, Raymond Simba, Jairus Oketch, Nixon Nyangweso, Mary Maina, Nicholas Kiswi, Michael Kirui, Betty Chirchir, Marc Goldstein, Mark A. Barone, Patricia Evelyn Fast.
The ShangRing is a disposable, collar clamp circumcision device pre-qualified for use in men and boys 13 years and above. It has been shown to be faster than conventional circumcision with comparable adverse event (AE) rates and high client satisfaction. Voluntary medical male circumcision (VMMC) has been shown to dramatically reduce the risk of HIV acquisition in males. However, the fear of pain during circumcision is an important barrier to uptake. Use of topical anesthesia thus presents an opportunity to address this.
We sought to evaluate the safety, effectiveness and acceptability of the use of topical anaesthesia with ShangRing circumcision of men and boys 10 years of age and above.
Participants were randomised 2:1 to receive topical or injectable anaesthesia. All participants underwent no-flip ShangRing circumcision. The primary outcome measure was pain. Secondary outcomes included ease of use of topical versus injectable anaesthesia, AEs and participant satisfaction.
Compared to the topical group, participants in the injectable group reported significantly more pain on administration of the anesthesia and at approximately 20 minutes after the procedure. In the topical group, sufficient anaesthesia with topical cream was not achieved in 21 (9.3%) cases before the start of the procedure; in another 6 (2.6%), supplementary injectable anaesthesia was required as the circumcision was being carried out. The AE rate was significantly lower (p<0.01) in the topical (0%) vs. the injectable group (4.2%). The most common AE was pain during the post-operative period. All AEs were managed conservatively and resolved without sequeale. 96.7% of participants were satisfied with the appearance of the healed penis and 100% would recommend the ShangRing to others. All seven male circumcision providers involved in the study preferred topical to injectable anaesthesia. Our results demonstrate the safety, improved clinical experience, effectiveness, and acceptability of the use of topical anaesthesia in ShangRing circumcision using the no-flip technique. Topical anaesthesia effectively eliminates needlestick pain from the clients’ VMMC experience and thus has the potential to increase demand for the service. ClinicalTrials.gov NCT02390310.
Male circumcision was proven to be effective in limiting the rate of female to male transmission of HIV in three randomised control trials (RCTs) by up to 60% [1–3] and could avert an estimated 3.7 million new infections between 2016–2026. Moreover, this protective effect was shown to last for at least 5 to 6 years [5,6]. It has also been shown to be a cost-effective HIV prevention intervention based on large net savings from averted HIV medical costs. Based on these findings, and recommendations from the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS), 14 sub-Saharan African countries, including Kenya, have been implementing voluntary medical male circumcision (VMMC) as part of their national HIV prevention programs [8,9]. The original goal was to provide VMMC to 80% of males aged 15–49 years in the 14 countries by 2016. As part of the continued efforts towards achievement of 80% coverage, improvements in the planning [10,11], demand creation , service provision  and surgical technique have been widely researched and adopted. Despite considerable progress, these goals were not achieved in the original timeline ; new goals outlined in the WHO 2016–2021 VMMC framework now aim to have 90% of males 10–29 years circumcised by 2021 . This translates to 27 million males in the 14 priority countries undergoing VMMC by 2020 [15,16] meaning countries will need to increase from the current rate of approximately 2.5–3 million circumcisions annually, to 5 million .
Our results show that ShangRing circumcision can be successfully and safely performed using the no-flip technique with TA in boys and men age 10 years and older. We found no difference in reported pain between the two groups immediately before and during circumcision, indicating that TA and IA were equally effective once anesthetic effect was achieved. Moreover, the reported pain experienced both during application of anesthetic and then approximately 20 minutes after completion of the circumcision were significantly lower in the TA group. The former is plausible given that there is no injection used, and the latter is most likely explained by the longer duration of action of topical cream compared to injectable lidocaine. Indeed, the perception of a painful injection has long been known to be a deterrent to men seeking VMMC services [20,21,40], so it is possible that use of TA could increase demand for VMMC. The overall AE rate was low; none of the AEs were related to use of TA. Three of the five AEs seen in the IA group were pain during the post-operative period, something that may be alleviated by the longer duration of action of TA.
Our results demonstrate the safety, improved clinical experience, effectiveness, and acceptability of TA for no-flip ShangRing circumcision Participants in the topical group experienced significantly less pain during the application of the anaesthesia and in the postoperative period. There were no difficulties during circumcision procedures or AEs associated with the use of topical anaesthetic cream. Although TA was not effective in inducing anaesthesia sufficiently to start the ShangRing circumcision in all participants, there were no AEs or other problems associated with the need to switch to IA when TA alone was not effective.