Urethral StrictureFIRST-CARENCT06827210
Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
A study testing Optilume DCB and Standard Direct Visual Internal Urethrotomy (DVIU) in people with Urethral Stricture and Urethral Stricture, Anterior, run by Aalborg University Hospital at 3 sites in Denmark.
Trial summary
This randomized controlled trial investigates the effectiveness and safety of the Optilume® drug-coated balloon (DCB) compared to standard direct visual internal urethrotomy (DVIU) in the treatment of bulbar urethral strictures. The primary objective is to assess freedom from repeat intervention at 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethral Stricture, Urethral Stricture, Anterior, Urethral Stricture, Male
- What is being tested?
- Optilume DCB and Standard Direct Visual Internal Urethrotomy (DVIU)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesDenmark
- Study dates
- 7 Feb 2025to Jul 2027
- Phase
- Interventional
- 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
Who may be able to join
- Male patients aged 18 years or older.
- Diagnosed with a treatment-naive, single bulbar urethral stricture.
- Stricture length ≤3 cm.
- Eligible for local treatment with paclitaxel.
- Able to provide written informed consent.
Who cannot join
- Female (chromosomal) sex.
- History of prior urethral stricture or prior treatment thereof.
- History of hypospadias repair.
- History of genital lichen sclerosis.
- Active or unresolved confounding etiology, including bladder neck contracture, neurogenic bladder, known or being evaluated for symptomatic benign prostatic hyperplasia (BPH) or surgical treatment for BPH within the last 5 years.
- Known allergy or hypersensitivity to paclitaxel or any component of the Optilume DCB.
Show all 9Show fewer
- Known peripheral artery disease.
- Severe comorbidities with an American Society of Anesthesiologists (ASA) score of 4 or higher.
- Patients unable to comply with follow-up protocols or provide informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites
Aalborg University Hospital
Aalborg, Region North Jutland, 9000
Marco B Mahdi, MD, +45 51 94 94 96 ext. +45, marco.mahdi@rn.dk
Tommy K Nielsen, MD, PHD, +45 61 31 91 53 ext. +45, t.kjaergaard@rn.dk
Gødstrup Regional Hospital
Gødstrup, Central Jutland, 7400
Charlotte H Graugaard-Jensen, MD, +45 41 40 95 74 ext. +45, chagra@rm.dk
North Denmark Regional Hospital
Hjørring, Region North Jutland, 9800
Henrik Weinreich, MD, +45 97 64 24 11 ext. +45, hew@rn.dk
About this study
This randomized controlled trial investigates the effectiveness and safety of the Optilume® drug-coated balloon (DCB) compared to standard direct visual internal urethrotomy (DVIU) in the treatment of bulbar urethral strictures. The primary objective is to assess freedom from repeat intervention at 12 months. Secondary objectives include evaluating urethral patency, urinary symptoms, and sexual function through objective measures (Qmax, PVR, cystoscopy) and patient-reported outcomes (USS-PROM, IPSS, IIEF-5). The study will recruit 140 participants across multiple sites, with follow-ups conducted at 6 and 12 months. This trial seeks to provide evidence for Optilume DCB as a safe and effective alternative to standard treatment.
Read the detailed description
This randomized controlled trial aims to evaluate the safety and efficacy of the Optilume® drug-coated balloon (DCB) in the treatment of bulbar urethral strictures. The trial includes adult male participants who have not received prior treatment for urethral strictures. Participants will be randomly assigned to one of two treatment groups: Optilume DCB or standard direct visual internal urethrotomy (DVIU).
The primary objective of the study is to compare the recurrence rate of urethral strictures at 12 months between the two groups. Secondary objectives include assessing patient-reported outcomes (using USS-PROM, IPSS, and IIEF-5), urethral patency (via Qmax and post-void residual volume), and safety (monitoring adverse events).
Follow-Up Schedule:
At Diagnosis: Baseline assessments will include cystoscopy, uroflowmetry (Qmax), post-void residual (PVR), patient-reported outcomes (USS-PROM, IPSS, and IIEF-5), and demographic data (age, sex, BMI, comorbidities, and smoking status). Informed consent will also be obtained.
Day 3 (Foley Removal): Participants will return for catheter removal. 6-Month Follow-Up: Assessments will include Qmax, PVR, and patient-reported outcomes (USS-PROM, IPSS, and IIEF-5).
12-Month Follow-Up: Final assessments will include cystoscopy, Qmax, PVR, and patient-reported outcomes (USS-PROM, IPSS, and IIEF-5).
The study will recruit 140 participants across multiple sites, with recruitment anticipated to span approximately 17.5 months. Data will be analyzed using Kaplan-Meier survival curves to compare recurrence rates, and log-rank tests will be used to assess statistical significance. Modified Poisson regression will be applied to evaluate potential confounders.
This study aims to provide robust evidence on the effectiveness of Optilume DCB in reducing stricture recurrence, improving patient outcomes, and offering a safe alternative to standard treatment.
- Conditions
- Urethral Stricture, Urethral Stricture, Anterior, Urethral Stricture, Male, Urethral Stricture Less Than 2 cm
- Being tested
- Optilume DCB, Standard Direct Visual Internal Urethrotomy (DVIU)
- Keywords
- Urethral Stricture, Optilume Drug-Coated Balloon, DVIU, Urology, Patient-Reported Outcomes
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optilume DCBDevice
Also called Drug-coated balloon
Optilume DCB is a drug-coated balloon catheter designed for the treatment of bulbar urethral strictures. It combines mechanical dilation with localized drug delivery to reduce stricture recurrence and promote urethral healing. The balloon is coated with paclitaxel, an antiproliferative agent, to minimize scar tissue formation and improve treatment outcomes.
Standard Direct Visual Internal Urethrotomy (DVIU)Procedure or surgery
Also called Sachse Internal Urethrotomy
Standard Direct Visual Internal Urethrotomy (DVIU), also known as Sachse Internal Urethrotomy, is a minimally invasive endoscopic procedure for treating urethral strictures.
| Study group | Role | What they receive |
|---|---|---|
| Optilume Drug-Coated Balloon (DCB) | Experimental | Participants in this arm will receive treatment with the Optilume drug-coated balloon (DCB), which combines mechanical dilation with localized drug delivery of paclitaxel to reduce stricture recurrence and promote healing. Receives: Device: Optilume DCB |
| Standard Direct Visual Internal Urethrotomy (DVIU) | Active comparator | Participants in this arm will undergo standard Direct Visual Internal Urethrotomy (DVIU), a commonly performed endoscopic procedure for the treatment of bulbar urethral strictures. Receives: Procedure: Standard Direct Visual Internal Urethrotomy (DVIU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Repeat Intervention at 12 Months
"The primary outcome is the proportion of participants who remain free from repeat intervention for urethral stricture recurrence at 12 months following treatment. Repeat intervention is defined as any procedure to address stricture recurrence, such as dilation, DVIU, or urethroplasty. Referrals for repeat interventions made within the 12-month follow-up period will also be included, even if the procedure itself is scheduled beyond the 12-month mark."
Measured: 12 months post-intervention
Secondary outcomes (8)
Urethral Patency Assessed via Cystoscopy at 12 Months
Urethral patency will be assessed using cystoscopy at 12 months. Patency is defined as the absence of visually confirmed narrowing that compromises the urethral lumen.
Measured: 12 months post-treatment
Maximum Urinary Flow Rate (Qmax) at 12 Months
The maximum urinary flow rate (Qmax) will be measured using uroflowmetry at 12 months as an indicator of urethral function. An improvement in Qmax is considered indicative of treatment success.
Measured: 12 months post-treatment
Post-Void Residual (PVR) Volume at 12 Months
Post-void residual (PVR) volume will be assessed using ultrasound at 12 months to evaluate bladder emptying efficiency. Lower PVR values are associated with successful treatment outcomes.
Measured: 12 months post-treatment
Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM)
The Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM) is a patient-reported outcome measure consisting of: (1) Lower Urinary Tract Symptoms Construct (Q1-6) from International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms Module (0-24, higher = worse symptoms); (2) LUTS-Specific QoL (Q7) (1-4, higher = worse QoL); (3) Peeling's Voiding Picture (Q8) (1-4, 1 = worst, 4 = best voiding); and (4) EQ-5D with an index value (1.000 to 0.033, higher = better health) and EQ-Visual Analogue Scale (0-100, higher = better health status), based on the Danish EQ-5D-5L Value Set (PMID 33527304).
Measured: 12 months post-treatment
International Prostate Symptom Score (IPSS) at 12 Months
The International Prostate Symptom Score (IPSS) is a patient-reported outcome measure assessing lower urinary tract symptoms (LUTS). It consists of seven symptom questions (Q1-7) scored from 0 to 5 (0 = no symptoms, 5 = most severe), with a total score range of 0 to 35 (higher = worse symptoms). An additional Quality of Life (QoL) question (Q8) is scored from 0 to 6 (0 = delighted, 6 = terrible), assessing the patient's perception of urinary symptoms.
Measured: 12 months post-treatment
International Index of Erectile Function (IIEF-5) at 12 Months
The International Index of Erectile Function-5 (IIEF-5) is a patient-reported outcome measure assessing erectile function. It consists of five questions (Q1-5), each scored from 1 to 5, with a total score range of 5 to 25. Higher scores indicate better erectile function, while lower scores suggest increasing severity of erectile dysfunction (22-25 = no dysfunction, 17-21 = mild, 12-16 = mild-moderate, 8-11 = moderate, 5-7 = severe).
Measured: 12 months post-treatment
Incidence of Adverse Events (AEs)
The incidence of adverse events (AEs) related to the intervention will be documented throughout the study. AEs include any unexpected or undesirable events, categorized by severity and relationship to the treatment.
Measured: From enrollment to 12 months post-treatment
Incidence of Postoperative Complications
The incidence of postoperative complications will be documented and categorized based on their severity.
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start7 Feb 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urethral StrictureStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gødstrup Hospital, Regionshospital Nordjylland
- Responsible party
- Principal investigator, Marco Bassam Mahdi, Aalborg University Hospital
- Investigators
- Tommy K Nielsen, MD, PHD, Principal investigator, Aalborg University HospitalMarco B Mahdi, MD, Principal investigator, Aalborg University HopsitalHenrik Weinreich, MD, Principal investigator, Regionshospital NordjyllandCharlotte H Graugaard-Jensen, MD, PHD, Principal investigator, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827210
- Sponsor's protocol ID
- F2024-214
- Acronym
- FIRST-CARE
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) will be shared upon reasonable request submitted to the sponsor and evaluated by the steering committee. Researchers must submit a formal request detailing the intended use. Approval will require signing a data access agreement to ensure the data is only used for predefined and accepted research purposes.
Publications
Al Taweel W, Seyam R. Visual Internal Urethrotomy for Adult Male Urethral Stricture Has Poor Long-Term Results. Adv Urol. 2015;2015:656459. doi: 10.1155/2015/656459. Epub 2015 Oct 1.
PubMed 26494995Harraz AM, El-Assmy A, Mahmoud O, Elbakry AA, Tharwat M, Omar H, Farg H, Laymon M, Mosbah A. Is there a way to predict failure after direct vision internal urethrotomy for single and short bulbar urethral strictures? Arab J Urol. 2015 Dec;13(4):277-81. doi: 10.1016/j.aju.2015.07.007. Epub 2015 Sep 3.
PubMed 26609447Redon-Galvez L, Molina-Escudero R, Alvarez-Ardura M, Otaola-Arca H, Alarcon Parra RO, Paez-Borda A. Predictors of urethral stricture recurrence after endoscopic urethrotomy. Actas Urol Esp. 2016 Oct;40(8):529-33. doi: 10.1016/j.acuro.2016.03.013. Epub 2016 May 17. English, Spanish.
PubMed 27207599Elliott SP, Coutinho K, Robertson KJ, D'Anna R, Chevli K, Carrier S, Aube-Peterkin M, Cantrill CH, Ehlert MJ, Te AE, Dann J, DeLong JM, Brandes SB, Hagedorn JC, Levin R, Schlaifer A, DeSouza E, DiMarco D, Erickson BA, Natale R, Husmann DA, Morey A, Olsson C, Virasoro R. One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume(R) Drug-Coated Balloon for Anterior Urethral Strictures. J Urol. 2022 Apr;207(4):866-875. doi: 10.1097/JU.0000000000002346. Epub 2021 Dec 2.
PubMed 34854748Virasoro R, DeLong JM, Estrella RE, Pichardo M, Rodriguez Lay R, Espino G, Elliott SP. A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study. Res Rep Urol. 2022 May 6;14:177-183. doi: 10.2147/RRU.S359872. eCollection 2022.
PubMed 35572815Barbagli G, Fossati N, Montorsi F, Balo S, Rimondi C, Larcher A, Sansalone S, Butnaru D, Lazzeri M. Focus on Internal Urethrotomy as Primary Treatment for Untreated Bulbar Urethral Strictures: Results from a Multivariable Analysis. Eur Urol Focus. 2020 Jan 15;6(1):164-169. doi: 10.1016/j.euf.2018.10.014. Epub 2018 Nov 6.
PubMed 30409684Kluth LA, Ernst L, Vetterlein MW, Meyer CP, Reiss CP, Fisch M, Rosenbaum CM. Direct Vision Internal Urethrotomy for Short Anterior Urethral Strictures and Beyond: Success Rates, Predictors of Treatment Failure, and Recurrence Management. Urology. 2017 Aug;106:210-215. doi: 10.1016/j.urology.2017.04.037. Epub 2017 May 4.
PubMed 28479479Mahdi MB, Haase RN, Sander L, Tuckus G, Liltorp DL, Jorgensen L, Graugaard-Jensen CH, Weinreich H, Pennisi CP, Nielsen TK. Treatment of bulbar urethral strictures with Optilume drug-coated balloons in a previously untreated population (FIRST-CARE): protocol for a single-blind multicentre randomised controlled trial. BMJ Open. 2026 Jan 8;16(1):e103948. doi: 10.1136/bmjopen-2025-103948.
PubMed 41506760
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
- ClinicalTrials.gov ID
- NCT06827210
- Acronym / sponsor ID
- FIRST-CARE / F2024-214
- Conditions
- Urethral Stricture, Urethral Stricture, Anterior, Urethral Stricture, Male, Urethral Stricture Less Than 2 cm
- Keywords
- Urethral Stricture, Optilume Drug-Coated Balloon, DVIU, Urology, Patient-Reported Outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Gødstrup Hospital, Regionshospital Nordjylland
- Study start
- 7 Feb 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Feb 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.
This randomized controlled trial investigates the effectiveness and safety of the Optilume® drug-coated balloon (DCB) compared to standard direct visual internal urethrotomy (DVIU) in the treatment of bulbar urethral strictures. The primary objective is to assess freedom from repeat intervention at 12 months. Secondary objectives include evaluating urethral patency, urinary symptoms, and sexual function through objective measures (Qmax, PVR, cystoscopy) and patient-reported outcomes (USS-PROM, IPSS, IIEF-5). The study will recruit 140 participants across multiple sites, with follow-ups conducted at 6 and 12 months. This trial seeks to provide evidence for Optilume DCB as a safe and effective alternative to standard treatment.
Detailed description
This randomized controlled trial aims to evaluate the safety and efficacy of the Optilume® drug-coated balloon (DCB) in the treatment of bulbar urethral strictures. The trial includes adult male participants who have not received prior treatment for urethral strictures. Participants will be randomly assigned to one of two treatment groups: Optilume DCB or standard direct visual internal urethrotomy (DVIU).
The primary objective of the study is to compare the recurrence rate of urethral strictures at 12 months between the two groups. Secondary objectives include assessing patient-reported outcomes (using USS-PROM, IPSS, and IIEF-5), urethral patency (via Qmax and post-void residual volume), and safety (monitoring adverse events).
Follow-Up Schedule:
At Diagnosis: Baseline assessments will include cystoscopy, uroflowmetry (Qmax), post-void residual (PVR), patient-reported outcomes (USS-PROM, IPSS, and IIEF-5), and demographic data (age, sex, BMI, comorbidities, and smoking status). Informed consent will also be obtained.
Day 3 (Foley Removal): Participants will return for catheter removal. 6-Month Follow-Up: Assessments will include Qmax, PVR, and patient-reported outcomes (USS-PROM, IPSS, and IIEF-5).
12-Month Follow-Up: Final assessments will include cystoscopy, Qmax, PVR, and patient-reported outcomes (USS-PROM, IPSS, and IIEF-5).
The study will recruit 140 participants across multiple sites, with recruitment anticipated to span approximately 17.5 months. Data will be analyzed using Kaplan-Meier survival curves to compare recurrence rates, and log-rank tests will be used to assess statistical significance. Modified Poisson regression will be applied to evaluate potential confounders.
This study aims to provide robust evidence on the effectiveness of Optilume DCB in reducing stricture recurrence, improving patient outcomes, and offering a safe alternative to standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optilume Drug-Coated Balloon (DCB) | Experimental | Device: Optilume DCBParticipants in this arm will receive treatment with the Optilume drug-coated balloon (DCB), which combines mechanical dilation with localized drug delivery of paclitaxel to reduce stricture recurrence and promote healing. |
| Standard Direct Visual Internal Urethrotomy (DVIU) | Active comparator | Procedure: Standard Direct Visual Internal Urethrotomy (DVIU)Participants in this arm will undergo standard Direct Visual Internal Urethrotomy (DVIU), a commonly performed endoscopic procedure for the treatment of bulbar urethral strictures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients aged 18 years or older.
- Diagnosed with a treatment-naive, single bulbar urethral stricture.
- Stricture length ≤3 cm.
- Eligible for local treatment with paclitaxel.
- Able to provide written informed consent.
Key exclusion criteria (9 listed)
- Female (chromosomal) sex.
- History of prior urethral stricture or prior treatment thereof.
- History of hypospadias repair.
- History of genital lichen sclerosis.
- Active or unresolved confounding etiology, including bladder neck contracture, neurogenic bladder, known or being evaluated for symptomatic benign prostatic hyperplasia (BPH) or surgical treatment for BPH within the last 5 years.
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 |
|---|---|---|
| Optilume DCBAlso: Drug-coated balloonOptilume DCB is a drug-coated balloon catheter designed for the treatment of bulbar urethral strictures. It combines mechanical dilation with localized drug delivery to reduce stricture recurrence and promote urethral healing. The balloon is coated with paclitaxel, an antiproliferative agent, to minimize scar tissue formation and improve treatment outcomes. | Device | Optilume Drug-Coated Balloon (DCB) |
| Standard Direct Visual Internal Urethrotomy (DVIU)Also: Sachse Internal UrethrotomyStandard Direct Visual Internal Urethrotomy (DVIU), also known as Sachse Internal Urethrotomy, is a minimally invasive endoscopic procedure for treating urethral strictures. | Procedure or surgery | Standard Direct Visual Internal Urethrotomy (DVIU) |
Primary outcome
Freedom from Repeat Intervention at 12 Months
Time frame: 12 months post-intervention
"The primary outcome is the proportion of participants who remain free from repeat intervention for urethral stricture recurrence at 12 months following treatment. Repeat intervention is defined as any procedure to address stricture recurrence, such as dilation, DVIU, or urethroplasty. Referrals for repeat interventions made within the 12-month follow-up period will also be included, even if the procedure itself is scheduled beyond the 12-month mark."
8 secondary outcomes
Urethral Patency Assessed via Cystoscopy at 12 Months
Time frame: 12 months post-treatment
Maximum Urinary Flow Rate (Qmax) at 12 Months
Time frame: 12 months post-treatment
Post-Void Residual (PVR) Volume at 12 Months
Time frame: 12 months post-treatment
Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM)
Time frame: 12 months post-treatment
International Prostate Symptom Score (IPSS) at 12 Months
Time frame: 12 months post-treatment
International Index of Erectile Function (IIEF-5) at 12 Months
Time frame: 12 months post-treatment
Incidence of Adverse Events (AEs)
Time frame: From enrollment to 12 months post-treatment
Incidence of Postoperative Complications
Time frame: 12 months post-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 14 Feb 2025.
- Results publication: PubMed 26494995Al Taweel W, Seyam R. Visual Internal Urethrotomy for Adult Male Urethral Stricture Has Poor Long-Term Results. Adv Urol. 2015;2015:656459. doi: 10.1155/2015/656459. Epub 2015 Oct 1.
- Results publication: PubMed 26609447Harraz AM, El-Assmy A, Mahmoud O, Elbakry AA, Tharwat M, Omar H, Farg H, Laymon M, Mosbah A. Is there a way to predict failure after direct vision internal urethrotomy for single and short bulbar urethral strictures? Arab J Urol. 2015 Dec;13(4):277-81. doi: 10.1016/j.aju.2015.07.007. Epub 2015 Sep 3.
- Results publication: PubMed 27207599Redon-Galvez L, Molina-Escudero R, Alvarez-Ardura M, Otaola-Arca H, Alarcon Parra RO, Paez-Borda A. Predictors of urethral stricture recurrence after endoscopic urethrotomy. Actas Urol Esp. 2016 Oct;40(8):529-33. doi: 10.1016/j.acuro.2016.03.013. Epub 2016 May 17. English, Spanish.
- Results publication: PubMed 34854748Elliott SP, Coutinho K, Robertson KJ, D'Anna R, Chevli K, Carrier S, Aube-Peterkin M, Cantrill CH, Ehlert MJ, Te AE, Dann J, DeLong JM, Brandes SB, Hagedorn JC, Levin R, Schlaifer A, DeSouza E, DiMarco D, Erickson BA, Natale R, Husmann DA, Morey A, Olsson C, Virasoro R. One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume(R) Drug-Coated Balloon for Anterior Urethral Strictures. J Urol. 2022 Apr;207(4):866-875. doi: 10.1097/JU.0000000000002346. Epub 2021 Dec 2.
- Results publication: PubMed 35572815Virasoro R, DeLong JM, Estrella RE, Pichardo M, Rodriguez Lay R, Espino G, Elliott SP. A Drug-Coated Balloon Treatment for Urethral Stricture Disease: Three-Year Results from the ROBUST I Study. Res Rep Urol. 2022 May 6;14:177-183. doi: 10.2147/RRU.S359872. eCollection 2022.
- Results publication: PubMed 30409684Barbagli G, Fossati N, Montorsi F, Balo S, Rimondi C, Larcher A, Sansalone S, Butnaru D, Lazzeri M. Focus on Internal Urethrotomy as Primary Treatment for Untreated Bulbar Urethral Strictures: Results from a Multivariable Analysis. Eur Urol Focus. 2020 Jan 15;6(1):164-169. doi: 10.1016/j.euf.2018.10.014. Epub 2018 Nov 6.
- Results publication: PubMed 28479479Kluth LA, Ernst L, Vetterlein MW, Meyer CP, Reiss CP, Fisch M, Rosenbaum CM. Direct Vision Internal Urethrotomy for Short Anterior Urethral Strictures and Beyond: Success Rates, Predictors of Treatment Failure, and Recurrence Management. Urology. 2017 Aug;106:210-215. doi: 10.1016/j.urology.2017.04.037. Epub 2017 May 4.
- Derived from this study: PubMed 41506760Mahdi MB, Haase RN, Sander L, Tuckus G, Liltorp DL, Jorgensen L, Graugaard-Jensen CH, Weinreich H, Pennisi CP, Nielsen TK. Treatment of bulbar urethral strictures with Optilume drug-coated balloons in a previously untreated population (FIRST-CARE): protocol for a single-blind multicentre randomised controlled trial. BMJ Open. 2026 Jan 8;16(1):e103948. doi: 10.1136/bmjopen-2025-103948.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) will be shared upon reasonable request submitted to the sponsor and evaluated by the steering committee. Researchers must submit a formal request detailing the intended use. Approval will require signing a data access agreement to ensure the data is only used for predefined and accepted research purposes.
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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.
Tommy K Nielsen, MD, PHD principal investigator
Aalborg University Hospital
Marco B Mahdi, MD principal investigator
Aalborg University Hopsital
Henrik Weinreich, MD principal investigator
Regionshospital Nordjylland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optilume DCB and Standard Direct Visual Internal Urethrotomy (DVIU) in people with Urethral Stricture and Urethral Stricture, Anterior, run by Aalborg University Hospital at 3 sites in Denmark.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 14 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 3 sites in Denmark. 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?
Contact Marco B Mahdi, MD (+45 51 94 94 96 ext. +45, marco.mahdi@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Repeat Intervention at 12 Months (time frame: 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827210, which also lists 8 linked publications.
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 14 Feb 2025.