Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon

Launched by VASTRA GOTALAND REGION · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people with recurrent urethral strictures, which are narrowings in the urethra that can cause difficulties with urination. The trial is comparing a special type of dilatation balloon coated with a medication called paclitaxel (known as Optilume) to a regular dilatation balloon that does not have the coating. The goal is to find out if the coated balloon can improve the success rate of treating these strictures and reduce the need for more invasive surgeries, like open urethroplasty, which is a more complex procedure.

To be eligible for this trial, participants need to be at least 18 years old and have experienced a recurrence of a urethral stricture after having at least one previous treatment. They must have a specific type of stricture (either in the penile or bulbar area) that is 2 cm or less in length and should be able to give informed consent. Throughout the trial, participants will receive either the paclitaxel-coated balloon or the standard balloon during a procedure, and the effectiveness of their treatment will be monitored. This trial is important because it could offer a new, less invasive option for people who have not found success with other treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Urethral stricture recurrence after at least one internal urethrotomy or dilatation
• • Penile or bulbar stricture
• • Length of stricture ≤ 2 cm
• • Eligible for open urethroplasty
• • Able to give informed consent
• Exclusion Criteria:
• • Stricture of the meatus
• • Sclerosis of the bladder neck
• • Multiple strictures \< 16 Ch
• • Complete stricture without any lumen
• • Previous dilatation with paclitaxel-coated balloon
• • Previous radiation therapy of the pelvis (e.g. for prostate cancer)
• • Previous pelvic fracture
• • Urethral malignancy
• • Presence of urethral fistula
• • Presence of urethral condyloma
• • Previous open urethroplasty
• • Chronic urinary retention secondary to detrusor inactivity