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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Urethral Stricture Disease

Intervention / Treatment
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* Radiation: Urografin 30%
* Radiation: NaCl 0,9 % in aqua


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional urethrography<br>Current golden standard. | Radiation: Urografin 30%<br>* 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.<br>|
| Experimental: Sono-urethrography<br>Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive. | Radiation: NaCl 0,9 % in aqua<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urethrography