MP67-06 RESULTS OF A RANDOMIZED CONTROLLED TRIAL OF SHANGRING VERSUS MOGEN CLAMP IN EARLY INFANT MALE CIRCUMCISION IN SUB-SAHARAN AFRICA

Abstract

You have accessJournal of UrologyGlobal Health/Humanitarian (MP67)1 Sep 2021MP67-06 RESULTS OF A RANDOMIZED CONTROLLED TRIAL OF SHANGRING VERSUS MOGEN CLAMP IN EARLY INFANT MALE CIRCUMCISION IN SUB-SAHARAN AFRICA Quincy Nang, Spyridon Basourakos, Nahid Punjani, Omar All Hussein Al Awamlh, Kaylee Ho, Karla Ballman, Mark Barone, Quentin Awori, Daniel Ouma, Alice Christensen, Godfrey Kigozi, Marc Goldstein, Philip Li, and Richard Lee Quincy NangQuincy Nang More articles by this author , Spyridon BasourakosSpyridon Basourakos More articles by this author , Nahid PunjaniNahid Punjani More articles by this author , Omar All Hussein Al AwamlhOmar All Hussein Al Awamlh More articles by this author , Kaylee HoKaylee Ho More articles by this author , Karla BallmanKarla Ballman More articles by this author , Mark BaroneMark Barone More articles by this author , Quentin AworiQuentin Awori More articles by this author , Daniel OumaDaniel Ouma More articles by this author , Alice ChristensenAlice Christensen More articles by this author , Godfrey KigoziGodfrey Kigozi More articles by this author , Marc GoldsteinMarc Goldstein More articles by this author , Philip LiPhilip Li More articles by this author , and Richard LeeRichard Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002028.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Early infant male circumcision (EIMC) is expected to help reduce HIV incidence and transmission given the compelling evidence in adults and adolescents. The ShangRing (SR) is the only World Health Organization prequalified circumcision device for males over 10 years requiring only topical peri-procedural anesthesia. We conducted the first large-scale randomized controlled trial in three sub-Saharan African countries comparing the safety and efficacy of the SR to current standard of care, the Mogen clamp (MoC) in early infants. METHODS: Healthy male infants from 11 sites in Kenya, Tanzania, and Uganda were equally randomized to EIMC with SR vs. MoC. Patients with congenital genitourinary anomalies, bleeding diathesis, or allergy to local anesthetics were excluded. Patients were followed for 42 days or until completion of healing. The primary endpoint was safety as defined by rates of adverse events. Secondary endpoints included procedural duration, pain (neonatal infant pain scale, NIPS), wound healing time, and parental satisfaction. RESULTS: A total of 1378 infant males were enrolled (SR: n=689, MoC: n=689). Patient groups were similar between devices, and within each country. The rates of adverse events were similar between the two groups (6.0% vs. 8.6%, p=0.08). No glandular injury (partial or total transection), severe wound infection, or hemorrhage were recorded. Post-operative mean NIPS scores in the SR and MC groups were 0.3±0.8 vs. 0.3±0.7 (p=0.29) respectively. All participants reached complete healing by post-operative day 42. No statistically significant differences were observed in supplemental local anesthetic rates (2.9% vs. 3%, p=1), procedural duration (mean 12.3±8.0 vs. 12.6±9.1 minutes, p=0.58), parental satisfaction with postoperative cosmesis (99.1% vs. 99.5%, p=0.60), and willingness to recommend circumcision (99.1% vs. 99.7%, p=0.22). CONCLUSIONS: EIMC with the SR is safe and does not significantly differ from the current standard of care. SR represents a unique opportunity to scale up EIMC services by implementing as a single-use device across all age ranges. Broad use of the SR, especially when targeted to males in early life, may further increase rates of circumcision in sub-Saharan Africa and subsequently lead to reductions in HIV transmission. Source of Funding: BMGF © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e511-e511 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Quincy Nang More articles by this author Spyridon Basourakos More articles by this author Nahid Punjani More articles by this author Omar All Hussein Al Awamlh More articles by this author Kaylee Ho More articles by this author Karla Ballman More articles by this author Mark Barone More articles by this author Quentin Awori More articles by this author Daniel Ouma More articles by this author Alice Christensen More articles by this author Godfrey Kigozi More articles by this author Marc Goldstein More articles by this author Philip Li More articles by this author Richard Lee More articles by this author Expand All Advertisement Loading ...