Optilume Registry for Treatment of Stricture of the Anterior Urethra

NCT05479422 | Active Not Recruiting

• 1 other identifier: PR1276-001
• Study Type: observational
• Target: 150
• Locations: 5 countries
• Sites: 13

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.

Conditions

Anterior Urethral Stricture, Male

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Secondary Outcomes (3)

• Frequency and Severity of Treatment Related Adverse Events

  Through study completion, an average of 3 years

• Freedom from Repeat Intervention

  Through study completion, an average of 3 years

• Anatomic Evaluation

  Through study completion, an average of 3 years

Study Arms (1)

Treatment of stricture of the anterior urethra with optilume DCB

Standard of care treatment of stricture of the anterior urethra using the Optilume Drug Coated Balloon.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male subjects (≥ 18 years old) with a recurrent anterior urethral stricture

You may qualify if:

• Male subjects ≥ 18 years old
• 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.
• Subject provides written informed consent using an approved Informed Consent Form (ICF) and is willing to comply with standard follow-up assessments.

You may not qualify if:

• Subjects with a known hypersensitivity to paclitaxel or structurally related compounds.
• Subject is unwilling to abstain or use a condom for 30 days after the procedure.
• Subject is unwilling to use highly effective contraception for 6 months after the procedure if partner is of childbearing potential.
• Subjects with a history of carcinoma of the genitourinary system (e.g., kidney, bladder, prostate, urethra, testes) that is not considered in complete remission.

Sponsors & Collaborators

• European Association of Urology Research Foundation: lead
• Laborie Medical Technologies Inc.: collaborator

Study Sites (13)

AZ Middelares

Ghent, Belgium

Location

Department of Urology - San Raffaele University

Milan, 20132, Italy

Location

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

Torino, Italy

Location

AOUI Verona, Urology Unit

Verona, Italy

Location

Oslo university hospital Rikshospitalet

Oslo, Norway

Location

Marques de Valdecilla University Hospital

Santander, Cantabria, 39008, Spain

Location

Lyx I Instituto de Urología

Madrid, Spain

Location

Hospital Universitario de Navarra

Pamplona, 31008, Spain

Location

Epsom and St Helier Hospitals

Carshalton, United Kingdom

Location

Frimley Park Hospital, Frimley Health NHS Foundation Trust

Frimley, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, United Kingdom

Location

Sheffield Teaching Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nadir I. Osman

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 29, 2022
• Study Start: October 13, 2022
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 15, 2029
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); GB (5); IT (3); NO (1); BE (1)