Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population

NANot yet recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

February 7, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

July 31, 2027

Conditions
Urethral StrictureUrethral Stricture, AnteriorUrethral Stricture, MaleUrethral Stricture Less Than 2 cm
Interventions
DEVICE

Optilume DCB

Optilume DCB is a drug-coated balloon catheter designed for the treatment of bulbar urethral strictures. It combines mechanical dilation with localized drug delivery to reduce stricture recurrence and promote urethral healing. The balloon is coated with paclitaxel, an antiproliferative agent, to minimize scar tissue formation and improve treatment outcomes.

PROCEDURE

Standard Direct Visual Internal Urethrotomy (DVIU)

Standard Direct Visual Internal Urethrotomy (DVIU), also known as Sachse Internal Urethrotomy, is a minimally invasive endoscopic procedure for treating urethral strictures.

Trial Locations (3)

7400

Gødstrup Regional Hospital, Gødstrup

9000

Aalborg University Hospital, Aalborg

9800

North Denmark Regional Hospital, Hjørring

All Listed Sponsors
collaborator

Gødstrup Hospital

OTHER

collaborator

Regionshospital Nordjylland

OTHER_GOV

lead

Aalborg University Hospital

OTHER

NCT06827210 - Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population | Biotech Hunter | Biotech Hunter