Optilume Registry for Treatment of Stricture of the Anterior Urethra

European Clinical Registry for Optilume Urethral Drug Coated Balloon

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Urethral Stricture, Male

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Wim Witjes, MD; Phone Number: +31 26 389 0677; Email: w.witjes@uroweb.org

Study Locations

• Belgium
  • Gent, Belgium
    • Recruiting
    • AZ Middelares
    • Contact: Marjan Waterloos, MD
• Italy
  • Milan, Italy, 20132
    • Not yet recruiting
    • Department of Urology - San Raffaele University
    • Contact: M. Bandini, MD
  • Torino, Italy
    • Recruiting
    • AOU "Città della Salute e della Scienza" University of Turin
    • Contact: M Falcone, MD
    • Principal Investigator: P Gontero
  • Verona, Italy
    • Recruiting
    • AOUI Verona, Urology Unit
    • Contact: Alessandro Antonelli, MD
• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo university hospital Rikshospitalet
    • Contact: Henriette V Holm, MD
• Spain
  • Madrid, Spain
    • Recruiting
    • Lyx I Instituto de Urología
    • Contact: Juan I.M. Salamanca, MD
  • Pamplona, Spain, 31008
    • Recruiting
    • Hospital Universitario de Navarra
    • Contact: Oscar Gorria, MD
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Marques de Valdecilla University Hospital
      • Contact: Felix Campos, MD
• United Kingdom
  • Carshalton, United Kingdom
    • Recruiting
    • Epsom and St Helier Hospitals
    • Contact: Pareeta Patel, MD
  • Frimley, United Kingdom
    • Recruiting
    • Frimley Park Hospital, Frimley Health NHS Foundation Trust
    • Contact: Andrew Chetwood, MD
  • Newcastle Upon Tyne, United Kingdom
    • Recruiting
    • Freeman Hospital
    • Contact: Trevor Dorkin, MD
  • Norwich, United Kingdom
    • Recruiting
    • Norfolk & Norwich University Hospital
    • Contact: Ruth Doherty, ND
  • Sheffield, United Kingdom
    • Recruiting
    • Sheffield Teaching Hospital
    • Contact: Nadir Osman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Through study completion, an average of 3 years
Anatomic Evaluation	Outcomes related to anatomic recurrence of the stricture will be summarized via descriptive statistics. Anatomic recurrence will be defined as urethral lumen <14F measured by the inability to pass a flexible cystoscope or as measured via urethrogram. Outcomes will be reported as those free from stricture recurrence utilizing both definitions, as well as reported separately for those undergoing cystoscopy and those undergoing urethrography.	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: European Association of Urology Research Foundation
• Collaborators: Laborie Medical Technologies Inc.
• Investigators: Principal Investigator: Nadir I. Osman, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 15, 2029

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: PR1276-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No