Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05479422

Optilume Registry for Treatment of Stricture of the Anterior Urethra

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Anterior Urethral Stricture, Male Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urethral Stricture Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

AZ Middelares, Ghent, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Responder Rate at 12 Months

    Time frame: 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.

  2. Rate of Treatment Related Serious Adverse Events at 3 months

    Time frame: 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.

Secondary outcomes

  1. Frequency and Severity of Treatment Related Adverse Events

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

    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.

  2. Freedom from Repeat Intervention

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

    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

  3. Anatomic Evaluation

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

    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.

Sponsors and collaborators

Lead sponsor

European Association of Urology Research Foundation

Other

Collaborators

  • Laborie Medical Technologies Inc.

Registry information

Official study title

European Clinical Registry for Optilume Urethral Drug Coated Balloon

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jul 29, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.