Clinical trial NCT06827210: Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
Official title: Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Gødstrup Hospital
name: Regionshospital Nordjylland
First posted: 2025-02-14
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Freedom from Repeat Intervention at 12 Months
timeFrame: 12 months post-intervention
Secondary outcomes:
measure: Urethral Patency Assessed via Cystoscopy at 12 Months
timeFrame: 12 months post-treatment
measure: Maximum Urinary Flow Rate (Qmax) at 12 Months
timeFrame: 12 months post-treatment
measure: Post-Void Residual (PVR) Volume at 12 Months
timeFrame: 12 months post-treatment
measure: Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM)
timeFrame: 12 months post-treatment
measure: International Prostate Symptom Score (IPSS) at 12 Months
timeFrame: 12 months post-treatment
measure: International Index of Erectile Function (IIEF-5) at 12 Months
timeFrame: 12 months post-treatment
measure: Incidence of Adverse Events (AEs)
timeFrame: From enrollment to 12 months post-treatment
measure: Incidence of Postoperative Complications
timeFrame: 12 months post-treatment
Other outcomes:
Locations:
city: Gødstrup
country: Denmark
facility: Gødstrup Regional Hospital
state: Central Denmark Region
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region North Jutland
city: Hjørring
country: Denmark
facility: North Denmark Regional Hospital
state: Region North Jutland
Study officials:
affiliation: Aalborg University Hospital
name: Tommy K Nielsen, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hopsital
name: Marco B Mahdi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regionshospital Nordjylland
name: Henrik Weinreich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gødstrup Hospital
name: Charlotte H Graugaard-Jensen, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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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citation: 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.
citation: 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.
citation: 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.
citation: 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.