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| Name | Class |
|---|---|
| Gødstrup Hospital | OTHER |
| Regionshospital Nordjylland | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optilume DCB | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 12 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post-treatment |
| Maximum Urinary Flow Rate (Qmax) at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco B Mahdi, MD | Contact | +45 51 94 94 96 | +45 | marco.mahdi@rn.dk |
| Tommy K Nielsen, MD, PHD | Contact | +45 61 31 91 53 | +45 | t.kjaergaard@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Tommy K Nielsen, MD, PHD | Aalborg University Hospital | Principal Investigator |
| Marco B Mahdi, MD | Aalborg University Hopsital | Principal Investigator |
| Henrik Weinreich, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gødstrup Regional Hospital | Gødstrup | Central Jutland | 7400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26494995 | Result | 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. | |
| 26609447 | Result | Harraz 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. |
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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.
Data will be available after the study's primary completion date and will be accessible for a period of 5 years.
Researchers requesting access must submit a formal request to the sponsor, outlining the intended use of the data. Access will be granted upon approval by the steering committee and will require signing a data access agreement to ensure responsible use.
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| Standard Direct Visual Internal Urethrotomy (DVIU) | Procedure | Standard Direct Visual Internal Urethrotomy (DVIU), also known as Sachse Internal Urethrotomy, is a minimally invasive endoscopic procedure for treating urethral strictures. |
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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. |
| 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. | 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). | 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. | 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). | 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. | 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. | 12 months post-treatment |
| Regionshospital Nordjylland |
| Principal Investigator |
| Charlotte H Graugaard-Jensen, MD, PHD | Gødstrup Hospital | Principal Investigator |
| Aalborg University Hospital | Aalborg | Region North Jutland | 9000 | Denmark |
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| North Denmark Regional Hospital | Hjørring | Region North Jutland | 9800 | Denmark |
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| 27207599 | Result | Redon-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. |
| 34854748 | Result | Elliott 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. |
| 35572815 | Result | Virasoro 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. |
| 30409684 | Result | Barbagli 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. |
| 28479479 | Result | Kluth 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. |
| 41506760 | Derived | Mahdi 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. |
| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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