Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
NCT ID: NCT06827210
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
140 participants
INTERVENTIONAL
2025-02-07
2027-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Gødstrup Hospital
OTHER
Regionshospital Nordjylland
OTHER_GOV
Aalborg University Hospital
OTHER
Responsible Party
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Marco Bassam Mahdi
MD, PhD Fellow, Principal Investigator
Principal Investigators
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Tommy K Nielsen, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Marco B Mahdi, MD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hopsital
Henrik Weinreich, MD
Role: PRINCIPAL_INVESTIGATOR
Regionshospital Nordjylland
Charlotte H Graugaard-Jensen, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Gødstrup Hospital
Locations
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Gødstrup Regional Hospital
Gødstrup, Central Jutland, Denmark
Aalborg University Hospital
Aalborg, Region North Jutland, Denmark
North Denmark Regional Hospital
Hjørring, Region North Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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F2024-214
Identifier Type: -
Identifier Source: org_study_id
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