🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 4Ages 18 Years - anyAllVastra Gotaland Region
NCT06795074 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

Urethral strictures are often initially treated endoscopically with dilatation or direct visual internal urethrotomy (DVIU), a procedure where the stricture is incised through the vision of a cystoscope. These methods are easy to perform, they are often well tolerated under local anesthesia and they have a low risk of complications. One disadvantage is the relatively low success rate which is 20-60% when used as a first intervention and considerably lower after several interventions. Instead of repeated endoscopic procedures, it is advisable to perform open urethroplasty. Urethroplasty has a success rate of 65-91% but a higher risk of complications and requires general anesthesia. Therefore, there is a need for a treatment option for recurrent urethral strictures after DVIU or dilatation, before the urethroplasty is performed. Optilume is a CE-marked paclitaxel-coated dilatation balloon

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • Optilume
  • UroMax Ultra
📍

Where

4 sites
Sahlgrenska University Hospital
Gothenburg, Sweden
Skåne University Hospital
Malmö, Sweden
Örebro University Hospital
Örebro, Sweden
Karolinska University Hospital
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy