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

This study is not yet open for participant recruitment.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01790776
First received: February 11, 2013
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Urethral Stricture Disease
 Radiation: Urografin 30%
Radiation: NaCl 0,9 % in aqua
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Radiation dose during diagnostic intervention. [ Time Frame: During urethrography. ] [ Designated as safety issue: Yes ]
    The radiation dose will be measured with a dosimeter.


Secondary Outcome Measures:
  • Diagnostic accuracy of sono-urethrography vs conventional urethrography. [ Time Frame: Immediately and 2 weeks after urethrography ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional urethrography
Current golden standard.
 Radiation: Urografin 30%

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.
Experimental: Sono-urethrography
Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.
 Radiation: NaCl 0,9 % in aqua
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790776

Contacts
Contact: Nicolaas Lumen, M.D., Ph.D. Nicolaas.Lument@uzgent.be

Locations
Belgium
Ghent University Hospital Not yet recruiting
Ghent, Belgium, 9000
Contact: Nicolaas Lumen, M.D., Ph.D.         Nicolaas.Lumen@uzgent.be    
Principal Investigator: Nicolaas Lumen, M.D., Ph.D.            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Nicolaas Lumen, M.D., Ph.D. Ghent University Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01790776     History of Changes
Other Study ID Numbers: 2012/902
Study First Received: February 11, 2013
Last Updated: February 13, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
urethrography

Additional relevant MeSH terms:
Urethral Stricture
Constriction, Pathologic
Urethral Obstruction
 Urethral Diseases
Urologic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 17, 2013