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

January 15, 2026 updated by: Vastra Gotaland Region

Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon - a Prospective Randomised Multicentre Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
      • Malmo, Sweden
        • Not yet recruiting
        • Skane University Hospital
        • Contact:
      • Stockholm, Sweden
        • Not yet recruiting
        • Karolinska University Hospital
        • Contact:
      • Örebro, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Paclitaxel-coated dilatation ballon
Dilatation of urethral stricture with paclitaxel-coated balloon
Combination product: Optilume
Dilatation with drug-coated balloon
Active Comparator: Non-coated dilatation balloon
Dilatation of urethral stricture with non-coated balloon
Device: UroMax Ultra
Dilatation with non-coated balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional recurrent stricture
Time Frame: Within 18 months of treatment

Recurrence within 18 months of a functional urethral stricture, defined as:

  1. Use of clean intermittent dilatation or
  2. Retreatment with dilatation balloon or internal urethrotomy or
  3. Need for open urethroplasty or other open procedure
Within 18 months of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anatomical recurrent stricture
Time Frame: Within 18 months of treatment
Anatomical recurrent stricture, defined as impassable with a 16 Fr flexible cystoscope
Within 18 months of treatment
Qmax
Time Frame: At 6 and 18 months after treatment
Change in maximum urinary flow after treatment
At 6 and 18 months after treatment
Time micturition
Time Frame: At 6 and 18 months after treatment
Change in time micturition (seconds for first 1dL voided urine)
At 6 and 18 months after treatment
Urethral Stricture Score
Time Frame: At 6, 12 and 18 months after treatment
Patient reported outcome measure (Urethral Stricture Surgery (USS)-PROM). Score from 0-24, higher indicates worse symptoms. Also includes a quality-of-life question and Peeling's voiding picture.
At 6, 12 and 18 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Skane
Region Stockholm
Region Örebro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RUSTIC
  • CIV-24-12-050340 (Other Identifier: Swedish Medical Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not allowed by ethical review authority

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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