Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography (SONO-URETHRA) (SONO-URETHRA)

Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography: Evaluation of the Diagnostic Value and Evaluation of the Reduction of the Radiation Dose With Sono-urethrography (SONO-URETHRA)

Conventional urethrography is the standard diagnostic evaluation for patients with a suspicion of urethral stricture. The radiation dose of this examination is 5-9 mSV. Sono-urethrography was introduced in 1988 (McAninch et al. , J Urol 1988); the diagnostic accuracy of sono-urethrography is equal compared to conventional urethrography, with even a better measurement of stricture length and degree of spongiofibrosis with sono-urethrography. However, sono-urethrography remained underused among urologists and radiologists.

Patients will be randomly assigned into two groups:

Group A: conventional urethrography Group B: sono-urethrography In case sono-urethrography is inconclusive or of poor quality, a conventional urethrography will be performed.

The radiation dose in the two groups will be measured. The stricture length and location will be recorded and compared with the perioperative findings in order to evaluate the diagnostic accuracy. The complications of the procedure(s) will be recorded with a questionnaire directly after and two weeks after the conventional or sono-urethrography.

Study Overview

• Status: Withdrawn
• Conditions: Urethral Stricture Disease
• Intervention / Treatment: Radiation: Urografin 30%; Radiation: NaCl 0,9 % in aqua

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with a suspicion of urethral stricture disease for which an indication of imaging of the urethra exists.

Exclusion Criteria:

• Transsexual patients.
• Patients with perineostomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional urethrography; Current golden standard.	Radiation: Urografin 30%; Urografin 30% (Natrium amidotrizoas 10G, Megalumin, Amidotrizoas 65G, Natrii calcii edetas, water for injection 250 ml, with 146 mg iodium/ml). The tip of a bladder catheter is placed at the external urethral meatus and fixed at this location. The solution (urografin 30 %) is instilled.
Experimental: Sono-urethrography; Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.	Radiation: NaCl 0,9 % in aqua; The tip of a bladder catheter is placed at the external urethral meatus and fixed at this location. The solution (NaCl 0,9 % in aqua) is instilled. If the result is inconclusive, urografin 30 % will be instilled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation dose during diagnostic intervention.	The radiation dose will be measured with a dosimeter.	During urethrography.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of sono-urethrography vs conventional urethrography.	The results of sono-urethrography and conventional urethrography will be compared with the intraoperative situation (place stricture, length stricture); contrast allergy and complications are scored with a questionnaire.	Immediately and 2 weeks after urethrography

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Nicolaas Lumen, M.D., Ph.D., University Hospital, Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: urethrography
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: 2012/902