Pre-operative Assessment by Sonourethrography Only in Anterior Urethral Strictures.

NCT04452890 | Completed

• 1 other identifier: BC-06980-ADP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The choice of the best surgical technique for urethral stricture repair depends on the stricture length. Estimating the length of urethral strictures is therefore of utmost importance. Different clinical studies have proven that SUG has a higher sensitivity to evaluate the length of urethral strictures compared to RUG or VCUG. The goal of this study is to assess the feasibility of using SUG as single pre-operative assessment tool in patients with suspicion of anterior urethral strictures. In this way, use of RUG and/or VCUG could be omitted in the pre-operative work-up of patients with anterior urethral strictures, thereby avoiding significant radiation load of patients.

Conditions

Anterior Urethral Stricture, Male

Outcome Measures

Primary Outcomes (1)

• Sonourethrography feasibility: proportion of patients in whom the pre-operative surgical treatment planning was accurate

  To evaluate the proportion of patients in whom the pre-operative surgical treatment planning was accurate based on sonourethrography only.

  2 years

Secondary Outcomes (1)

• Identification of predictors for failure of treatment planning by sonourethrography by regression analysis.

  2 years

Study Arms (1)

Sonourethrography

EXPERIMENTAL

Ultrasound of the urethra (Sonourethrography - SUG): In this procedure, a Foley catheter is inserted into the top of the urethra and physiological serum is instilled into the urethra while a linear 7.5 MHz ultrasound probe is placed sagitally on the course of the urethra to detect a narrowing of the urethra.

Diagnostic Test: Sonourethrography

Interventions

Sonourethrography DIAGNOSTIC_TEST

Ultrasound of the urethra.

Sonourethrography

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only biological males with anterior urethral stricture disease will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older
• Anterior urethral strictures (except for meatal strictures)

You may not qualify if:

• Posterior urethral strictures
• Meatal strictures
• History of hypospadias repair
• History of phalloplasty

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Dept. of Urology, Ghent University Hospital

Ghent, 9000, Belgium

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, prospective feasibility trial

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 7, 2022

Record last verified: 2020-06

Locations

BE (1)