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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- University Hospital, Ghent
- Locations
- 1
- Primary Endpoint
- Radiation dose during diagnostic intervention.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Conventional urethrography
Current golden standard.
Intervention: Urografin 30% (Radiation)
Sono-urethrography
Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.
Intervention: NaCl 0,9 % in aqua (Radiation)
Outcomes
Primary Outcomes
Radiation dose during diagnostic intervention.
Time Frame: During urethrography.
The radiation dose will be measured with a dosimeter.
Secondary Outcomes
- Diagnostic accuracy of sono-urethrography vs conventional urethrography.(Immediately and 2 weeks after urethrography)