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

NCT06827210 | Not Yet Recruiting FDA Device

• 1 other identifier: F2024-214
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Urethral Patency Assessed via Cystoscopy at 12 Months

  12 months post-treatment

• Maximum Urinary Flow Rate (Qmax) at 12 Months

  12 months post-treatment

• Post-Void Residual (PVR) Volume at 12 Months

  12 months post-treatment

• Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM)

  12 months post-treatment

• International Prostate Symptom Score (IPSS) at 12 Months

  12 months post-treatment

Study Arms (2)

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.

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.

Procedure: Standard Direct Visual Internal Urethrotomy (DVIU)

Interventions

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.

Also known as: Drug-coated balloon

Optilume Drug-Coated Balloon (DCB)

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.

Also known as: Sachse Internal Urethrotomy

Standard Direct Visual Internal Urethrotomy (DVIU)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Gødstrup Hospital: collaborator
• Regionshospital Nordjylland: collaborator

Study Sites (3)

Gødstrup Regional Hospital

Gødstrup, Central Jutland, 7400, Denmark

Location

Aalborg University Hospital

Aalborg, Region North Jutland, 9000, Denmark

Location

North Denmark Regional Hospital

Hjørring, Region North Jutland, 9800, Denmark

Location

Related Publications (8)

• 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 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.

  PMID: 26609447 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.

  PMID: 27207599 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.

  PMID: 34854748 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.

  PMID: 35572815 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.

  PMID: 30409684 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.

  PMID: 28479479 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tommy K Nielsen, MD, PHD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Marco B Mahdi, MD

  Aalborg University Hopsital

  PRINCIPAL INVESTIGATOR

• Henrik Weinreich, MD

  Regionshospital Nordjylland

  PRINCIPAL INVESTIGATOR

• Charlotte H Graugaard-Jensen, MD, PHD

  Gødstrup Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco B Mahdi, MD

CONTACT

+45 51 94 94 96; marco.mahdi@rn.dk

Tommy K Nielsen, MD, PHD

CONTACT

+45 61 31 91 53; t.kjaergaard@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Fellow, Principal Investigator

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 14, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after the study's primary completion date and will be accessible for a period of 5 years.
• Access Criteria: 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.

Locations

DK (3)