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

Not Applicable

Not yet recruiting

• Conditions: Urethral Stricture; Urethral Stricture, Anterior; Urethral Stricture, Male; Urethral Stricture Less Than 2 cm

• Registration Number: NCT06827210
• Lead Sponsor: Aalborg University Hospital

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.

Study Timeline

• Study First Submitted: 2025-01-30
• Status Verified: 2025-02
• Study Start: 2025-02-07
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Primary Completion: 2027-01
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from Repeat Intervention at 12 Months	12 months post-intervention	"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."

Secondary Outcome Measures

Name	Time	Method
Urethral Patency Assessed via Cystoscopy at 12 Months	12 months post-treatment	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.
Maximum Urinary Flow Rate (Qmax) at 12 Months	12 months post-treatment	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.
Post-Void Residual (PVR) Volume at 12 Months	12 months post-treatment	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.
Urethral Stricture Surgery Patient-Reported Outcome Measure (USS-PROM)	12 months post-treatment	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).
International Prostate Symptom Score (IPSS) at 12 Months	12 months post-treatment	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.
International Index of Erectile Function (IIEF-5) at 12 Months	12 months post-treatment	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).
Incidence of Adverse Events (AEs)	From enrollment to 12 months post-treatment	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.
Incidence of Postoperative Complications	12 months post-treatment	The incidence of postoperative complications will be documented and categorized based on their severity.

Trial Locations

Locations (3)

Gødstrup Regional Hospital; 🇩🇰 Gødstrup, Central Denmark Region, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Region North Jutland, Denmark

North Denmark Regional Hospital; 🇩🇰 Hjørring, Region North Jutland, Denmark