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

Ghent University Hospital (UZ)

Status and phase: Withdrawn; Phase 3

Conditions: Urethral Stricture Disease

Treatments: Radiation: Urografin 30%; Radiation: NaCl 0,9 % in aqua

Study type: Interventional

Funder types: Other

Identifiers

NCT01790776

2012/902

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Conventional urethrography

Active Comparator group

Description:

Current golden standard.

Treatment:

Radiation: Urografin 30%

Sono-urethrography

Experimental group

Description:

Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.

Treatment:

Radiation: NaCl 0,9 % in aqua