Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New balloon treatment aims to cut repeat surgeries for narrowed urethra

NCT ID NCT06795074

Disease control Sponsor: Vastra Gotaland Region Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special balloon coated with the drug paclitaxel (Optilume) can prevent urethral strictures from returning better than a standard balloon. About 230 adults with a recurrent stricture after at least one prior treatment will be randomly assigned to one of the two balloons. The main goal is to see if the coated balloon reduces the need for further procedures or open surgery within 18 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Urethral stricture are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

urethral stricture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urethral stricture

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Karolinska University Hospital

    NOT_YET_RECRUITING

    Stockholm, Sweden

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

  • Skåne University Hospital

    NOT_YET_RECRUITING

    Malmö, Sweden

  • Örebro University Hospital

    NOT_YET_RECRUITING

    Örebro, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.