A phase II randomized controlled trial of a novel male contraception, an intra-vas device.

The aim of this study was to introduce a novel male contraceptive method, an intra-vas device (IVD), and to assess the efficacy, safety and satisfaction of recipients compared with no-scalpel vasectomy (NSV). A phase II randomized controlled trial was conducted in China in 2003. Two hundred and eighty-eight male subjects seeking vasectomy were randomly assigned to the IVD or NSV group. Follow up included a telephone questionnaire on the 14th postoperative day and visits at the third and 12th postoperative months. The follow-up rates at the three time points were 100%, 100% and 96.5% respectively. There was no technical failure in any subject. The surgical conditions were similar in both groups, but the IVD group experienced an additional 5 min of operative time (p<0.001). The IVD group recovered normal activity and sexual intercourse more rapidly (both p<0.05). The azoospermia rate was lower in the IVD group than in the NSV group at the third and 12th postoperative months. The rate of contraceptive success based on semen analyses was similar in both groups, especially at the 12th postoperative month (94.3% in the IVD group vs. 98.6% in the NSV group; p=0.054). The IVD group had less risk of complications (i.e. pain, congestive epididymitis and sperm granuloma). More subjects reported satisfaction with IVD sterilization than with NSV. The two procedures were similar in terms of surgical complications. The IVD was slightly less effective, but had a lower risk of later adverse events than the NSV technique. The IVD group also reported a higher level of satisfaction.

RCT Entities:   Population Interventions Outcomes