Anterior Urethral Stricture, MaleNCT05479422
Optilume Registry for Treatment of Stricture of the Anterior Urethra
An observational study of Anterior Urethral Stricture, Male, run by European Association of Urology Research Foundation at 13 sites in 5 countries.
Trial summary
The purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Anterior Urethral Stricture, Male
- How many people
- 150 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 13 Oct 2022to 15 Aug 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male subjects (≥ 18 years old) with a recurrent anterior urethral stricture
Who may be able to join
- Male subjects ≥ 18 years old
- Subject diagnosed with a recurrent stricture ≤3cm in the anterior urethra that plans to be treated with Optilume® DCB in accordance with the approved Instructions for Use.
- Subject provides written informed consent using an approved Informed Consent Form (ICF) and is willing to comply with standard follow-up assessments.
Who cannot join
- Subjects with a known hypersensitivity to paclitaxel or structurally related compounds.
- Subject is unwilling to abstain or use a condom for 30 days after the procedure.
- Subject is unwilling to use highly effective contraception for 6 months after the procedure if partner is of childbearing potential.
- Subjects with a history of carcinoma of the genitourinary system (e.g., kidney, bladder, prostate, urethra, testes) that is not considered in complete remission.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United Kingdom5 sites
Epsom and St Helier Hospitals
Carshalton
Frimley Park Hospital, Frimley Health NHS Foundation Trust
Frimley
Freeman Hospital
Newcastle upon Tyne
Norfolk & Norwich University Hospital
Norwich
Sheffield Teaching Hospital
Sheffield
Italy3 sites
Department of Urology - San Raffaele University
Milan, 20132
AOU "Città della Salute e della Scienza" University of Turin
Torino
AOUI Verona, Urology Unit
Verona
Spain3 sites
Lyx I Instituto de Urología
Madrid
Hospital Universitario de Navarra
Pamplona, 31008
Marques de Valdecilla University Hospital
Santander, Cantabria, 39008
About this study
Official title: European Clinical Registry for Optilume Urethral Drug Coated Balloon
The purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture.
Read the detailed description
After being informed about the registry and potential risks, all patients providing written informed consent will undergo urethral dilation using the Optilume Drug Coated Balloon (standard of care procedure).
At 3, 6, 12 months, and annually 2 to 5 years after treatment patients will be invited to return to the hospital and several assessments will be performed, including questionnaires, if this is part of their standard care.
- Conditions
- Anterior Urethral Stricture, Male
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of stricture of the anterior urethra with optilume DCB | Standard of care treatment of stricture of the anterior urethra using the Optilume Drug Coated Balloon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate at 12 Months
The responder rate is defined as the proportion of subjects experiencing a ≥30% improvement in International Prostate Symptom Score (IPSS) without repeat intervention for the study stricture. The responder rate at 12 months post-treatment will be compared against a performance goal of 60%.
The International Prostate Symptom Score (IPSS) (score 0-7 = mild; score 8-19 = mediate; score 20-35 = severe complaints) was chosen as the primary patient-reported outcome measure (PROM) for follow-up due to its inclusion in the EAU guidelines, its long history of use, its inclusion as the primary PROM in the ROBUST clinical program, and the availability of literature describing clinically meaningful improvement in the setting of bladder outlet obstruction.
Measured: 12 months
Rate of Treatment Related Serious Adverse Events at 3 months
The primary safety endpoint is defined as the proportion of subjects experiencing a treatment related Serious Adverse Event (SAE) through 3 months post-treatment. The primary safety endpoint will be analyzed with descriptive statistics and nominal 95% confidence interval.
No single event type is expected to happen with greater frequency than other endoscopic therapies, therefore any event that meets the definition of an SAE and is considered treatment related will be included in the endpoint.
Measured: 3 months
Secondary outcomes (3)
Frequency and Severity of Treatment Related Adverse Events
The proportion of subjects experiencing treatment related adverse events will be summarized by event type and severity as graded by the Clavien-Dindo scale. 'Treatment Related' consists of events deemed Possible, Probable, or Definite in relation to the Optilume® DCB or the dilation procedure.
Measured: Through study completion, an average of 3 years
Freedom from Repeat Intervention
Defined as freedom from any reintervention for the stricture treated during the index procedure, including but not limited to:
- Urethroplasty
- Dilation with sounds, bougies, balloon, etc.
- Direct vision internal urethrotomy
- Dilation with the Optilume® DCB
- Intermittent self-dilation / Clean Intermittent Catheterization (CIC)
- Indwelling catheter (urethral or suprapubic)
- Urethral stent
Measured: Through study completion, an average of 3 years
Anatomic Evaluation
Outcomes related to anatomic recurrence of the stricture will be summarized via descriptive statistics. Anatomic recurrence will be defined as urethral lumen <14F measured by the inability to pass a flexible cystoscope or as measured via urethrogram. Outcomes will be reported as those free from stricture recurrence utilizing both definitions, as well as reported separately for those undergoing cystoscopy and those undergoing urethrography.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start13 Oct 2022
- Primary completion15 Aug 2029 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Urethral Stricture, MaleStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- European Association of Urology Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Laborie Medical Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Nadir I. Osman, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479422
- Sponsor's protocol ID
- PR1276-001
- Status last verified
- Feb 2025
- First submitted
- 27 Jun 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Clinical Registry for Optilume Urethral Drug Coated Balloon
- ClinicalTrials.gov ID
- NCT05479422
- Acronym / sponsor ID
- PR1276-001
- Conditions
- Anterior Urethral Stricture, Male
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- European Association of Urology Research FoundationUniversity, hospital or other
- Collaborators
- Laborie Medical Technologies Inc.
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 29 Jul 2022 (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.
The purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture.
Detailed description
After being informed about the registry and potential risks, all patients providing written informed consent will undergo urethral dilation using the Optilume Drug Coated Balloon (standard of care procedure).
At 3, 6, 12 months, and annually 2 to 5 years after treatment patients will be invited to return to the hospital and several assessments will be performed, including questionnaires, if this is part of their standard care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of stricture of the anterior urethra with optilume DCB | – | –Standard of care treatment of stricture of the anterior urethra using the Optilume Drug Coated Balloon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male subjects (≥ 18 years old) with a recurrent anterior urethral stricture
Key inclusion criteria (3 listed)
- Male subjects ≥ 18 years old
- Subject diagnosed with a recurrent stricture ≤3cm in the anterior urethra that plans to be treated with Optilume® DCB in accordance with the approved Instructions for Use.
- Subject provides written informed consent using an approved Informed Consent Form (ICF) and is willing to comply with standard follow-up assessments.
Key exclusion criteria (4 listed)
- Subjects with a known hypersensitivity to paclitaxel or structurally related compounds.
- Subject is unwilling to abstain or use a condom for 30 days after the procedure.
- Subject is unwilling to use highly effective contraception for 6 months after the procedure if partner is of childbearing potential.
- Subjects with a history of carcinoma of the genitourinary system (e.g., kidney, bladder, prostate, urethra, testes) that is not considered in complete remission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Responder Rate at 12 Months
Time frame: 12 months
The responder rate is defined as the proportion of subjects experiencing a ≥30% improvement in International Prostate Symptom Score (IPSS) without repeat intervention for the study stricture. The responder rate at 12 months post-treatment will be compared against a performance goal of 60%. The International Prostate Symptom Score (IPSS) (score 0-7 = mild; score 8-19 = mediate; score 20-35 = severe complaints) was chosen as the primary patient-reported outcome measure (PROM) for follow-up due to its inclusion in the EAU guidelines, its long history of use, its inclusion as the primary PROM in the ROBUST clinical program, and the availability of literature describing clinically meaningful improvement in the setting of bladder outlet obstruction.
Rate of Treatment Related Serious Adverse Events at 3 months
Time frame: 3 months
The primary safety endpoint is defined as the proportion of subjects experiencing a treatment related Serious Adverse Event (SAE) through 3 months post-treatment. The primary safety endpoint will be analyzed with descriptive statistics and nominal 95% confidence interval. No single event type is expected to happen with greater frequency than other endoscopic therapies, therefore any event that meets the definition of an SAE and is considered treatment related will be included in the endpoint.
3 secondary outcomes
Frequency and Severity of Treatment Related Adverse Events
Time frame: Through study completion, an average of 3 years
Freedom from Repeat Intervention
Time frame: Through study completion, an average of 3 years
Anatomic Evaluation
Time frame: Through study completion, an average of 3 years
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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nadir I. Osman principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Urethral Stricture, Male, run by European Association of Urology Research Foundation at 13 sites in 5 countries.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, Italy, Spain, Belgium, Norway. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate at 12 Months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 24 Feb 2025.