Drug-coated balloon catheter for the treatment of urethral strictures

Erdos J, Pleyer J
Record ID 32018014477
English
Authors' objectives: 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.
Authors' results and conclusions: 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.
Authors' recommendations: Further comparative studies are necessary to strengthen the evidence. A re-evaluation is recommended as soon as the BALDIKA study data becomes available.
Details
Project Status: Completed
URL for project: https://aihta.at/page/bewertung-medizinischer-einzelleistungen-mel-berichte/en
Year Published: 2025
URL for published report: https://eprints.aihta.at/1565/1/DSD_144.pdf
URL for additional information: https://eprints.aihta.at/1565/
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Urethral Stricture
  • Intermittent Urethral Catheterization
  • Paclitaxel
  • Urologic Surgical Procedures, Male
  • Male
  • Urinary Tract Infections
  • Dilatation
  • Minimally Invasive Surgical Procedures
Keywords
  • Drug-coated balloon catheter
  • urethral stricture
  • dilation
  • urethrotomy
  • urethroplasty
Contact
Organisation Name: Austrian Institute for Health Technology Assessment
Contact Address: Josefstaedter Strasse 39, A-1080 Vienna, Austria
Contact Name: office@aihta.at
Contact Email: office@aihta.at
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.