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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Unknown status

CT.gov ID

NCT01790776

Collaborator

(none)

150

Enrollment

Location

Arms

33.9

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Radiation dose during diagnostic intervention. [During urethrography.]
The radiation dose will be measured with a dosimeter.

Secondary Outcome Measures

Diagnostic accuracy of sono-urethrography vs conventional urethrography. [Immediately and 2 weeks after 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Ghent		Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Nicolaas Lumen, M.D., Ph.D., University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT01790776

Other Study ID Numbers:

2012/902

First Posted:

Feb 13, 2013

Last Update Posted:

Jun 3, 2015

Last Verified:

Jun 1, 2015

Keywords provided by University Hospital, Ghent

urethrography

Additional relevant MeSH terms:

Urethral Stricture

Constriction, Pathologic

Study Results

No Results Posted as of Jun 3, 2015