Safety and efficacy of a novel disposable circumcision device: a pilot randomized controlled clinical trial at 2 centers.

BACKGROUND

We evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd.

MATERIAL AND

METHODS

Adult male patients (n=120; mean age, 26.6 years) with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial from October 2011 to February 2012. Patients were divided into 2 groups and subjected to MC with a novel disposable device (Device Group) (n=60) or to conventional dissection technique (CDT) (Control Group) (n=60). Intraoperative bleeding, surgery duration, pain, healing, and satisfaction with penis appearance were assessed. Adverse events (AEs) were noted.

RESULTS

Intraoperative bleeding volume [3.5 ± 2.7 (15-35) ml vs. 13.1 ± 6.1 (4-25) ml] and mean surgical time [7.6 ± 4.5 (2-23) min vs. 23.6 ± 4.4 (15-35) min] in the Device Group were significantly less than in the Control Group (P<0.01). No AEs were observed in either group. There were no significant differences in postoperative pain, healing, or satisfaction with penis appearance between groups (P>0.05).

CONCLUSIONS

This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments. This device may be broadly used in men, such as those with phimosis, who are ineligible for CDT.