Presentation Authors: Omar Al Hussein Alawamlh*, Soo Jeong Kim, Mark Barone, New York, NY, Quentin Awori, Nairobi, Kenya, Jairus Oketch, Patrick Otiende, Nixon Nyangweso, Homa Bay, Kenya, Mary Maina, Nicholas Kiswi, Kilifi, Kenya, Marc Goldstein, Philip S. Li, Richard K. Lee, New York, NY
Introduction: Voluntary medical male circumcision (VMMC) has shown to reduce HIV transmission by 60%. The WHO and UNAIDS have recommended that VMMC be made available in 14 sub-Saharan African countries with high HIV prevalence and low male circumcision (MC) rates. Thus, device-assisted MC has been proposed as a method to simplify MC and enable safe task-shifting to non-physician healthcare providers, especially in regions lacking medical resources and trained physicians. The ShangRing (SR) is a WHO-prequalified MC device usable across all ages. The integration of topical anesthesia (TA) with SR MC would further simplify the procedure and broaden its appeal. In this randomized clinical trial (RCT), we compared the safety and efficacy of TA vs. injectable anesthesia (IA) with SR MC.
Methods: 344 males aged 10-54 years were enrolled in a two center RCT in Kenya. Participants were randomized in 2 to 1 fashion to TA using 2.5% lidocaine + 2.5% prilocaine cream vs. IA using 1% lidocaine. All participants were circumcised using the no-flip SR technique, which involves the insertion of an inner plastic ring under the foreskin followed by secure clamping of an outer ring to provide hemostatic occlusion. The foreskin distal to the device is then excised. Data on pain scores using the Visual Analogue Pain Scale, rate of adverse events (AEs), operative time, and time to complete wound healing were collected.
Results: 226 participants were allocated to TA vs. 118 to IA. All (100%) participants were successfully circumcised. 21 of the 226 participants initially assigned to TA required IA due to inadequate application of TA. Mean pain scores during application of anesthesia was significantly lower (0.02 vs. 1.2, p < 0.001) with TA. Mean pain scores during MC were similar (0.2 vs. 0.1, p=0.11) for both groups but lower with TA 20 minutes post-operatively (0.3 vs. 1.6, p < 0.001). No AEs were encountered. Mean operative time (5.0 vs. 5.1, p=0.61) and rates of complete wound healing on day 42 post-circumcision were similar (86.0% vs. 87.6%, p=0.80) between the two groups (Table 1).
Conclusions: TA was safe and efficacious with SR MC, demonstrating a superior anesthetic effect pre and post-operatively to IA. The use of TA could potentially increase recruitment of patients for MC, which would further the goal of increasing the rate of MC in sub-Saharan Africa.
Source of Funding: Bill & Melinda Gates Foundation