Actively Recruiting
Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon - a Prospective Randomised Multicentre Study
Led by Vastra Gotaland Region · Updated on 2026-01-16
230
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
R
Region Skane
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a paclitaxel-coated dilatation balloon called Optilume can improve treatment outcomes for people with recurrent urethral strictures after previous endoscopic treatments such as dilatation or direct visual internal urethrotomy (DVIU). Urethral strictures are narrowings of the urethra that often require intervention, and while open urethroplasty has a higher success rate, it carries more risks and requires general anesthesia. This study focuses on patients who might otherwise be candidates for open urethroplasty due to recurrence after less invasive procedures. Participants will be randomly assigned to receive either dilatation using the paclitaxel-coated balloon (Optilume) or a non-coated balloon (UroMax Ultra) to treat their urethral stricture. Both treatments involve the use of a balloon device to widen the narrowed urethra. The study compares these two methods to see if the drug coating can reduce the chance of stricture recurrence and the need for further interventions or surgery. The trial is a prospective, randomized, multicenter study with a Phase 4 designation. During the study, participants will be followed for up to 18 months after treatment to track outcomes such as functional and anatomical recurrence of the stricture, urine flow rate (Qmax), time to urinate, and urethral stricture scores at multiple time points. Researchers will collect these measurements at 6, 12, and 18 months to assess the effectiveness of the interventions. The study excludes patients with certain conditions such as complete strictures without any lumen, previous radiation therapy, or previous open urethroplasty. Participants must be able to provide informed consent and be eligible for open urethroplasty.
CONDITIONS
Brief Title
Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Recurrent urethral stricture after at least one internal urethrotomy or dilatation
- Stricture located in penile or bulbar urethra
- Length of stricture 2 cm or less
- Eligible for open urethroplasty
- Able to give informed consent
You will not qualify if you...
- Stricture of the meatus
- Sclerosis of the bladder neck
- Multiple strictures less than 16 Ch
- Complete stricture without any lumen
- Previous dilatation with paclitaxel-coated balloon
- Previous radiation therapy of the pelvis
- Previous pelvic fracture
- Urethral malignancy
- Presence of urethral fistula
- Presence of urethral condyloma
- Previous open urethroplasty
- Chronic urinary retention due to detrusor inactivity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo dilatation of urethral stricture with either a paclitaxel-coated balloon or a non-coated balloon.
1 treatment visit (in-person)
Duration - Up to 18 months
Participants are monitored for recurrence of urethral stricture and other outcomes after treatment.
Visits at 6, 12, and 18 months after treatment
Trial Site Locations
Total: 4 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Skåne University Hospital
Malmö, Sweden
Not Yet Recruiting
3
Örebro University Hospital
Örebro, Sweden
Not Yet Recruiting
4
Karolinska University Hospital
Stockholm, Sweden
Not Yet Recruiting
Research Team
H
Henrik Kjölhede, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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