Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population (FIRST-CARE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Urethral Stricture; Urethral Stricture, Anterior; Urethral Stricture, Male; Urethral Stricture Less Than 2 cm
• Intervention / Treatment: Device: Optilume DCB; Procedure: Standard Direct Visual Internal Urethrotomy (DVIU)

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco B Mahdi, MD; Phone Number: +45 +45 51 94 94 96; Email: marco.mahdi@rn.dk
• Study Contact Backup: Name: Tommy K Nielsen, MD, PHD; Phone Number: +45 +45 61 31 91 53; Email: t.kjaergaard@rn.dk

Study Locations

• Denmark
  • Central Denmark Region
    • Gødstrup, Central Denmark Region, Denmark, 7400
      • Gødstrup Regional Hospital
      • Contact: Charlotte H Graugaard-Jensen, MD; Phone Number: +45 +45 41 40 95 74; Email: chagra@rm.dk
  • Region North Jutland
    • Aalborg, Region North Jutland, Denmark, 9000
      • Aalborg University Hospital
      • Contact: Marco B Mahdi, MD; Phone Number: +45 +45 51 94 94 96; Email: marco.mahdi@rn.dk
      • Contact: Tommy K Nielsen, MD, PHD; Phone Number: +45 +45 61 31 91 53; Email: t.kjaergaard@rn.dk
      • Principal Investigator: Marco B Mahdi, MD
    • Hjørring, Region North Jutland, Denmark, 9800
      • North Denmark Regional Hospital
      • Contact: Henrik Weinreich, MD; Phone Number: +45 +45 97 64 24 11; Email: hew@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optilume Drug-Coated Balloon (DCB); 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; 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.; Other Names: Drug-coated balloon
Active Comparator: 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.	Procedure: 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.; Other Names: Sachse Internal Urethrotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Gødstrup Hospital; Regionshospital Nordjylland
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Patient-Reported Outcomes; Urology; Urethral Stricture; Optilume Drug-Coated Balloon; DVIU
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urethral Diseases; Urethral Obstruction; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: F2024-214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available after the study's primary completion date and will be accessible for a period of 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes