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

NCT01790776 | Withdrawn Phase 3

• 1 other identifier: 2012/902
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urethral Stricture Disease

Keywords

urethrography

Outcome Measures

Primary Outcomes (1)

• Radiation dose during diagnostic intervention.

  The radiation dose will be measured with a dosimeter.

  During urethrography.

Secondary Outcomes (1)

• Diagnostic accuracy of sono-urethrography vs conventional urethrography.

  Immediately and 2 weeks after urethrography

Study Arms (2)

Conventional urethrography

ACTIVE COMPARATOR

Current golden standard.

Radiation: Urografin 30%

Sono-urethrography

EXPERIMENTAL

Experimental urethrography, which could be followed by conventional urethrography if the results are inconclusive.

Radiation: NaCl 0,9 % in aqua

Interventions

Urografin 30% RADIATION

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.

Conventional urethrography

NaCl 0,9 % in aqua RADIATION

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.

Sono-urethrography

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a suspicion of urethral stricture disease for which an indication of imaging of the urethra exists.

You may not qualify if:

• Transsexual patients.
• Patients with perineostomy.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

• Related Info

Study Officials

• Nicolaas Lumen, M.D., Ph.D.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

BE (1)