Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Optilume DCB
  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.
• Процедура Standard Direct Visual Internal Urethrotomy (DVIU)
  Standard Direct Visual Internal Urethrotomy (DVIU), also known as Sachse Internal Urethrotomy, is a minimally invasive endoscopic procedure for treating urethral strictures.

Первичные конечные точки

• Freedom from Repeat Intervention at 12 Months [Срок оценки: 12 months post-intervention]

Вторичные конечные точки (8)

• Urethral Patency Assessed via Cystoscopy at 12 Months [Срок оценки: 12 months post-treatment]
• Maximum Urinary Flow Rate (Qmax) at 12 Months [Срок оценки: 12 months post-treatment]
• Post-Void Residual (PVR) Volume at 12 Months [Срок оценки: 12 months post-treatment]
• Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM) [Срок оценки: 12 months post-treatment]
• International Prostate Symptom Score (IPSS) at 12 Months [Срок оценки: 12 months post-treatment]
• International Index of Erectile Function (IIEF-5) at 12 Months [Срок оценки: 12 months post-treatment]
• Incidence of Adverse Events (AEs) [Срок оценки: From enrollment to 12 months post-treatment]
• Incidence of Postoperative Complications [Срок оценки: 12 months post-treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 3 центра

• Gødstrup Regional Hospital — Gødstrup
• Aalborg University Hospital — Aalborg
• North Denmark Regional Hospital — Hjørring

Публикации

• 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. PMID 26494995
• 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. PMID 26609447
• 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. PMID 27207599
• 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 Ureth PMID 34854748
• 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. PMID 35572815
• 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. PMID 30409684
• 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. PMID 28479479
• 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. PMID 41506760

Идентификаторы

NCT: NCT06827210 · F2024-214

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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