Optilume Registry for Treatment of Stricture of the Anterior Urethra

N/AActive Not RecruitingNCT05479422

European Association of Urology Research Foundation150 enrolled

Overview

The purpose of this registry is verifying the continued safety and effectiveness of the Optilume DCB clinical use in patients undergoing dilation of the urethral stricture.

After being informed about the registry and potential risks, all patients providing written informed consent will undergo urethral dilation using the Optilume Drug Coated Balloon (standard of care procedure). At 3, 6, 12 months, and annually 2 to 5 years after treatment patients will be invited to return to the hospital and several assessments will be performed, including questionnaires, if this is part of their standard care.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Anterior Urethral Stricture, Male

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male subjects ≥ 18 years old 2. Subject diagnosed with a recurrent stricture ≤3cm in the anterior urethra that plans to be treated with Optilume® DCB in accordance with the approved Instructions for Use. 3. Subject provides written informed consent using an approved Informed Consent Form (ICF) and is willing to comply with standard follow-up assessments. Exclusion Criteria: 1. Subjects with a known hypersensitivity to paclitaxel or structurally related compounds. 2. Subject is unwilling to abstain or use a condom for 30 days after the procedure. 3. Subject is unwilling to use highly effective contraception for 6 months after the procedure if partner is of childbearing potential. 4. Subjects with a history of carcinoma of the genitourinary system (e.g., kidney, bladder, prostate, urethra, testes) that is not considered in complete remission.

Locations (13)

AZ Middelares

Ghent, Belgium

Department of Urology - San Raffaele University

Milan, Italy

AOU "Città della Salute e della Scienza" University of Turin

Torino, Italy

Outcomes

Primary Outcomes

Responder Rate at 12 Months

The responder rate is defined as the proportion of subjects experiencing a ≥30% improvement in International Prostate Symptom Score (IPSS) without repeat intervention for the study stricture. The responder rate at 12 months post-treatment will be compared against a performance goal of 60%. The International Prostate Symptom Score (IPSS) (score 0-7 = mild; score 8-19 = mediate; score 20-35 = severe complaints) was chosen as the primary patient-reported outcome measure (PROM) for follow-up due to its inclusion in the EAU guidelines, its long history of use, its inclusion as the primary PROM in the ROBUST clinical program, and the availability of literature describing clinically meaningful improvement in the setting of bladder outlet obstruction.

Time frame: 12 months

Rate of Treatment Related Serious Adverse Events at 3 months

The primary safety endpoint is defined as the proportion of subjects experiencing a treatment related Serious Adverse Event (SAE) through 3 months post-treatment. The primary safety endpoint will be analyzed with descriptive statistics and nominal 95% confidence interval. No single event type is expected to happen with greater frequency than other endoscopic therapies, therefore any event that meets the definition of an SAE and is considered treatment related will be included in the endpoint.

Time frame: 3 months

Secondary Outcomes

Frequency and Severity of Treatment Related Adverse Events

The proportion of subjects experiencing treatment related adverse events will be summarized by event type and severity as graded by the Clavien-Dindo scale. 'Treatment Related' consists of events deemed Possible, Probable, or Definite in relation to the Optilume® DCB or the dilation procedure.

Time frame: Through study completion, an average of 3 years

Freedom from Repeat Intervention

Defined as freedom from any reintervention for the stricture treated during the index procedure, including but not limited to: * Urethroplasty * Dilation with sounds, bougies, balloon, etc. * Direct vision internal urethrotomy * Dilation with the Optilume® DCB * Intermittent self-dilation / Clean Intermittent Catheterization (CIC) * Indwelling catheter (urethral or suprapubic) * Urethral stent

Data from ClinicalTrials.gov

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