Clinical trial NCT05479422: Optilume Registry for Treatment of Stricture of the Anterior Urethra
Official title: European Clinical Registry for Optilume Urethral Drug Coated Balloon
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anterior Urethral Stricture, Male
Lead sponsor: European Association of Urology Research Foundation
Sponsor class: OTHER
Collaborators: name: Laborie Medical Technologies Inc.
First posted: 2022-07-29
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male subjects (≥ 18 years old) with a recurrent anterior urethral stricture

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Responder Rate at 12 Months
timeFrame: 12 months
measure: Rate of Treatment Related Serious Adverse Events at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Frequency and Severity of Treatment Related Adverse Events
timeFrame: Through study completion, an average of 3 years
measure: Freedom from Repeat Intervention
timeFrame: Through study completion, an average of 3 years
measure: Anatomic Evaluation
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Middelares
city: Milan
country: Italy
facility: Department of Urology - San Raffaele University
city: Torino
country: Italy
facility: AOU "Città della Salute e della Scienza" University of Turin
city: Verona
country: Italy
facility: AOUI Verona, Urology Unit
city: Oslo
country: Norway
facility: Oslo university hospital Rikshospitalet
city: Santander
country: Spain
facility: Marques de Valdecilla University Hospital
state: Cantabria
city: Madrid
country: Spain
facility: Lyx I Instituto de Urología
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Carshalton
country: United Kingdom
facility: Epsom and St Helier Hospitals
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital, Frimley Health NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Nadir I. Osman
role: PRINCIPAL_INVESTIGATOR
References: