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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-16

Study Completion Date

2031-02-28

Brief Summary

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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 used for treatment of urethral strictures. The industry-sponsored randomised ROBUST III trial from 2022 showed a 75% success rate with Optilume but it is not sure if the results can be generalised to patients who would otherwise be candidates for open urethroplasty and whether the drug coating per se increases the efficacy of balloon dilatation. The aim of this study is to investigate whether the addition of paclitaxel-coating can increase the success rate and decrease the need for additional interventions and open urethroplasty for individuals who has a recurrent urethral stricture following at least one previous endoscopic intervention.

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Detailed Description

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Conditions

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Urethral Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel-coated dilatation ballon

Dilatation of urethral stricture with paclitaxel-coated balloon

Group Type EXPERIMENTAL

Optilume

Intervention Type COMBINATION_PRODUCT

Dilatation with drug-coated balloon

Non-coated dilatation balloon

Dilatation of urethral stricture with non-coated balloon

Group Type ACTIVE_COMPARATOR

UroMax Ultra

Intervention Type DEVICE

Dilatation with non-coated balloon

Interventions

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Optilume

Dilatation with drug-coated balloon

Intervention Type COMBINATION_PRODUCT

UroMax Ultra

Dilatation with non-coated balloon

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No