Urethral strictures in men can lead to obstructive voiding disorders and complications such as urinary tract infections and kidney impairment. The drug-coated balloon (DCB) catheter offers an alternative to endoscopic treatment (dilation and urethrotomy) as well as to urethroplasty for recurrent short bulbar strictures.

One randomised controlled study on efficacy and three single-arm studies on safety were included. There are no ongoing studies; a non-manufacturer-sponsored study, BALDIKA, is planned however to test the superiority of the DCB over surgical interventions in recurrent strictures.

The available evidence shows that DCB catheter has some short-term benefit over a mixed comparison group of urethrotomy and dilation, but long-term effectiveness is uncertain. The safety profile is favourable. Further comparative studies are necessary to strengthen the evidence. A re-evaluation is recommended as soon as the BALDIKA study data becomes available.