DoVe Trial: a Randomized Controlled Trial Comparing Dorsal Onlay Versus Ventral Onlay in Isolated Bulbar Urethral Strictures
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
For bulbar urethral strictures, it remains unclear whether ventral onlay graft urethroplasty is non-inferior to dorsal onlay graft urethroplasty in terms of patency rates.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations (Appendix B).
• Age ≥ 18 years.
• Male patient.
• Fit for operation, based on the surgeon's expert opinion.
• Isolated bulbar urethral stricture confirmed by imaging.
• Preputium, penile shaft skin, buccal mucosa and lingual mucosa are allowed as free graft material in the executed dorsal onlay or ventral onlay FGU.
• Patient is able and willing to attend the follow-up consultations.
Locations
Other Locations
Belgium
Ghent University Hospital
RECRUITING
Ghent
Contact Information
Primary
Nicolaas Lumen
nicolaas.lumen@uzgent.be
+32 9 332 22 76
Backup
Wesley Verla
nicolaas.lumen@uzgent.be
+32 9 332 22 76
Time Frame
Start Date: 2020-03-04
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 240
Treatments
Active_comparator: Dorsal onlay graft urethroplasty
Experimental: Ventral onlay graft urethroplasty
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Ghent