A Phase 3 interventional study of Urografin 30% and NaCl 0,9 % in aqua in Urethral Stricture Disease, sponsored by University Hospital, Ghent. Withdrawn at 1 site in Belgium. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by University Hospital, Ghent · Phase 3, Interventional, and Other
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.
68 studies on the registry are indexed under Urethral Stricture; 23 are open to participants now.
Browse Urethral Stricture studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
Current golden standard.
Radiation: Urografin 30%
Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.
Radiation: NaCl 0,9 % in aqua
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.
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.
Radiation dose during diagnostic intervention.
The radiation dose will be measured with a dosimeter.
Time frame: During urethrography.
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.
Time frame: Immediately and 2 weeks after urethrography
This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent