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Compares treatment options for Urethral Stricture
Official title Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon
ClinicalTrials.gov ID: NCT06795074
What this study is testing
What is Optilume?
Optilume is an investigational medicine, being studied as a potential treatment for urethral stricture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
- Malmö, Sweden
- Örebro, Sweden
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden; Malmö, Sweden; Örebro, Sweden; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.