Optilume Registry for Treatment of Stricture of the Anterior Urethra

Anterior Urethral Stricture, Male Clinical Trial

Official title:

European Clinical Registry for Optilume Urethral Drug Coated Balloon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479422
• Other study ID #: PR1276-001
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: August 15, 2029

Study information

• Verified date: May 2024
• Source: European Association of Urology Research Foundation
• Contact: Wim Witjes, MD
• Phone: +31 26 389 0677
• Email: w.witjes[@]uroweb.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 15, 2029
• Est. primary completion date: August 15, 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Urethral Stricture, Male
• Constriction, Pathologic
• Urethral Stricture

Locations

Country	Name	City	State
Belgium	AZ Middelares	Gent
Italy	Department of Urology - San Raffaele University	Milan
Italy	AOU "Città della Salute e della Scienza" University of Turin	Torino
Italy	AOUI Verona, Urology Unit	Verona
Norway	Oslo university hospital Rikshospitalet	Oslo
Spain	Lyx I Instituto de Urología	Madrid
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Marques de Valdecilla University Hospital	Santander	Cantabria
United Kingdom	Epsom and St Helier Hospitals	Carshalton
United Kingdom	Frimley Park Hospital, Frimley Health NHS Foundation Trust	Frimley
United Kingdom	Freeman Hospital	Newcastle Upon Tyne
United Kingdom	Norfolk & Norwich University Hospital	Norwich
United Kingdom	Sheffield Teaching Hospital	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
European Association of Urology Research Foundation	Laborie Medical Technologies Inc.

Countries where clinical trial is conducted

Belgium,  Italy,  Norway,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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