Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography (SONO-URETHRA) (SONO-URETHRA)
Primary Purpose
Urethral Stricture Disease
Status
Withdrawn
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Urografin 30%
NaCl 0,9 % in aqua
Sponsored by
About this trial
This is an interventional other trial for Urethral Stricture Disease focused on measuring urethrography
Eligibility Criteria
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.
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional urethrography
Sono-urethrography
Arm Description
Current golden standard.
Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.
Outcomes
Primary Outcome Measures
Radiation dose during diagnostic intervention.
The radiation dose will be measured with a dosimeter.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01790776
First Posted
February 11, 2013
Last Updated
January 24, 2023
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01790776
Brief Title
Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography (SONO-URETHRA)
Acronym
SONO-URETHRA
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Study Start Date
February 2013 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture Disease
Keywords
urethrography
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional urethrography
Arm Type
Active Comparator
Arm Description
Current golden standard.
Arm Title
Sono-urethrography
Arm Type
Experimental
Arm Description
Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.
Intervention Type
Radiation
Intervention Name(s)
Urografin 30%
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
NaCl 0,9 % in aqua
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiation dose during diagnostic intervention.
Description
The radiation dose will be measured with a dosimeter.
Time Frame
During urethrography.
Secondary Outcome Measure Information:
Title
Diagnostic accuracy of sono-urethrography vs conventional urethrography.
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaas Lumen, M.D., Ph.D.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
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Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography (SONO-URETHRA)
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