Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Aalborg University Hospital
- Enrollment
- 140
- Locations
- 3
- Primary Endpoint
- Freedom from Repeat Intervention at 12 Months
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Optilume DCB (Device)
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.
Intervention: Standard Direct Visual Internal Urethrotomy (DVIU) (Procedure)
Outcomes
Primary Outcomes
Freedom from Repeat Intervention at 12 Months
Time Frame: 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 Outcomes
- 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)
- International Index of Erectile Function (IIEF-5) at 12 Months(12 months post-treatment)
- Incidence of Adverse Events (AEs)(From enrollment to 12 months post-treatment)
- Incidence of Postoperative Complications(12 months post-treatment)
Investigators
Marco Bassam Mahdi
MD, PhD Fellow, Principal Investigator
Aalborg University Hospital