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

Phase 3

Withdrawn

• Conditions: Urethral Stricture Disease
• Interventions: Radiation: Urografin 30%; Radiation: NaCl 0,9 % in aqua

• Registration Number: NCT01790776
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional urethrography	Urografin 30%	Current golden standard.
Sono-urethrography	NaCl 0,9 % in aqua	Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.

Primary Outcome Measures

Name	Time	Method
Radiation dose during diagnostic intervention.	During urethrography.	The radiation dose will be measured with a dosimeter.

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of sono-urethrography vs conventional urethrography.	Immediately and 2 weeks after 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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium