Paclitaxel-coated versus standard dilatation balloon for recurrent urethral stricture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.