title: The Shang Ring device for adult male circumcision: a proof of concept study in Kenya.
abstract: 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.
authors.affiliation: EngenderHealth, New York, NY 10001, USA. mbarone@engenderhealth.org
authors.forename: Mark A
authors.initials: MA
authors.lastname: Barone
authors.forename: Frederick
authors.initials: F
authors.lastname: Ndede
authors.forename: Philip S
authors.initials: PS
authors.lastname: Li
authors.forename: Puneet
authors.initials: P
authors.lastname: Masson
authors.forename: Quentin
authors.initials: Q
authors.lastname: Awori
authors.forename: Jairus
authors.initials: J
authors.lastname: Okech
authors.forename: Peter
authors.initials: P
authors.lastname: Cherutich
authors.forename: Nicholas
authors.initials: N
authors.lastname: Muraguri
authors.forename: Paul
authors.initials: P
authors.lastname: Perchal
authors.forename: Richard
authors.initials: R
authors.lastname: Lee
authors.forename: Howard H
authors.initials: HH
authors.lastname: Kim
authors.forename: Marc
authors.initials: M
authors.lastname: Goldstein
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods* / Q000523:psychology; D006801:Humans; D007630:Kenya; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010413:Penis / Q000601:surgery*; D055815:Young Adult