Paclitaxel-coated versus standard dilatation balloon for recurrent urethral stricture
Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon - a Prospective Randomised Multicentre Study
This trial tests if a paclitaxel-coated dilatation balloon (Optilume) reduces the chance of urethral stricture coming back compared with a non-coated balloon in adults who have had previous dilations or DVIU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Drugs / interventions | radiation |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Trial ID | NCT06795074 on ClinicalTrials.gov |
What this trial studies
This is a phase 4, randomized comparison of a paclitaxel-coated dilatation balloon (Optilume) versus a non-coated dilatation balloon (UroMax Ultra) for adults with recurrent penile or bulbar urethral strictures up to 2 cm. Eligible participants have had at least one prior internal urethrotomy or dilation and are candidates for open urethroplasty; key exclusions include complete strictures without a lumen, prior pelvic radiation, prior paclitaxel balloon dilation, and prior open urethroplasty. The trial is conducted at multiple university hospitals in Sweden and measures the risk of stricture recurrence after treatment with either device. Follow-up visits are required to monitor for recurrence and complications.
Who should consider this trial
Good fit: Adults aged 18 or older with a recurrent penile or bulbar urethral stricture ≤2 cm after at least one internal urethrotomy or dilation who are eligible for urethroplasty.
Not a fit: Patients with complete strictures without any lumen, meatal strictures, multiple small-caliber strictures, prior paclitaxel-coated balloon treatment, prior pelvic radiation, prior pelvic fracture, urethral malignancy, fistula, condyloma, previous open urethroplasty, or chronic urinary retention from detrusor inactivity are unlikely to benefit from the balloon treatment in this protocol.
Why it matters
Potential benefit: If successful, this could lower recurrence rates and help patients avoid or delay open urethroplasty.
How similar studies have performed: Paclitaxel-coated urethral balloons like Optilume have CE marking and prior industry-sponsored randomized trials (for example ROBUST III) have shown promising results, though independent long-term evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg and 3 other locations
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Skåne University Hospital — Malmö, Sweden (Not_yet_recruiting)
- Örebro University Hospital — Örebro, Sweden (Not_yet_recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Not_yet_recruiting)
Study contacts
- Study coordinator: Henrik Kjölhede, MD, PhD
- Email: henrik.kjolhede@vgregion.se
- Phone: +46-31-3421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.