Urethral StricturePhase 4RUSTICNCT06795074
Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon
A Phase 4 study testing Optilume and UroMax Ultra in people with Urethral Stricture, run by Vastra Gotaland Region at 4 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Optilume and UroMax Ultra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 4 sitesSweden
- Study dates
- 16 Jan 2026to Feb 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- Previous pelvic fracture
- Urethral malignancy
- Presence of urethral fistula
- Presence of urethral condyloma
- Previous open urethroplasty
- Chronic urinary retention secondary to detrusor inactivity
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Henrik Kjölhede, MD PhD, +46-31-3421000, henrik.kjolhede@vgregion.se
- Not yet recruiting
Skåne University Hospital
Malmö
Wolfgang Soller, MD, PhD, +46-40-33 10 00, wolfgang.soller@skane.se
- Not yet recruiting
Örebro University Hospital
Örebro
Beata Persson, MD, +46-19-602 10 00, beata.persson@regionorebrolan.se
- Not yet recruiting
Karolinska University Hospital
Stockholm
Christine Reus, MD, PhD, +46-8-123 70 000, christine.reus@ki.se
About this study
Official title: 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.
- Conditions
- Urethral Stricture
- Being tested
- Optilume, UroMax Ultra
- Keywords
- drug-coated dilatation balloon
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptilumeCombination product
Dilatation with drug-coated balloon
UroMax UltraDevice
Dilatation with non-coated balloon
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-coated dilatation ballon | Experimental | Dilatation of urethral stricture with paclitaxel-coated balloon Receives: Combination Product: Optilume |
| Non-coated dilatation balloon | Active comparator | Dilatation of urethral stricture with non-coated balloon Receives: Device: UroMax Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional recurrent stricture
Recurrence within 18 months of a functional urethral stricture, defined as:
- Use of clean intermittent dilatation or
- Retreatment with dilatation balloon or internal urethrotomy or
- Need for open urethroplasty or other open procedure
Measured: Within 18 months of treatment
Secondary outcomes (4)
Anatomical recurrent stricture
Anatomical recurrent stricture, defined as impassable with a 16 Fr flexible cystoscope
Measured: Within 18 months of treatment
Qmax
Change in maximum urinary flow after treatment
Measured: At 6 and 18 months after treatment
Time micturition
Change in time micturition (seconds for first 1dL voided urine)
Measured: At 6 and 18 months after treatment
Urethral Stricture Score
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.
Measured: At 6, 12 and 18 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start16 Jan 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Region Skane, Region Stockholm, Region Örebro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795074
- Sponsor's protocol ID
- RUSTIC
- Other IDs
- CIV-24-12-050340
- Acronym
- RUSTIC
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not allowed by ethical review authority
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Recurrent Urethral Stricture After Treatment With Paclitaxel-Coated Dilatation Balloon (Optilume) Compared With Non-coated Dilatation Balloon - a Prospective Randomised Multicentre Study
- ClinicalTrials.gov ID
- NCT06795074
- Acronym / sponsor ID
- RUSTIC / RUSTIC
- Conditions
- Urethral Stricture
- Keywords
- drug-coated dilatation balloon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Region Skane, Region Stockholm, Region Örebro
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-coated dilatation ballon | Experimental | Combination Product: OptilumeDilatation of urethral stricture with paclitaxel-coated balloon |
| Non-coated dilatation balloon | Active comparator | Device: UroMax UltraDilatation of urethral stricture with non-coated balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Stricture of the meatus
- Sclerosis of the bladder neck
- Multiple strictures < 16 Ch
- Complete stricture without any lumen
- Previous dilatation with paclitaxel-coated balloon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptilumeDilatation with drug-coated balloon | Combination product | Paclitaxel-coated dilatation ballon |
| UroMax UltraDilatation with non-coated balloon | Device | Non-coated dilatation balloon |
Primary outcome
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
4 secondary outcomes
Anatomical recurrent stricture
Time frame: Within 18 months of treatment
Qmax
Time frame: At 6 and 18 months after treatment
Time micturition
Time frame: At 6 and 18 months after treatment
Urethral Stricture Score
Time frame: At 6, 12 and 18 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No. Not allowed by ethical review authority
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Optilume and UroMax Ultra in people with Urethral Stricture, run by Vastra Gotaland Region at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrik Kjölhede, MD, PhD (+46-31-3421000, henrik.kjolhede@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional recurrent stricture (time frame: Within 18 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.