UnknownNot Applicable

DoVe Trial: Dorsal Onlay Versus Ventral Onlay in Isolated Bulbar Urethral Strictures

Belgium240 participantsStarted 2020-03-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Absence of signed written informed consent (Appendix B). * Age \< 18 years. * Female patients. * Transgender patients. * Patients unfit for operation. * Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck). * A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck). * Prior bulbar urethroplasty. * Lichen Sclerosus related strictures. * Strictures after failed hypospadias repair. * Patients with neurogenic bladder. * History of pelvic radiation therapy. * Shift of technique to any other technique than dorsal or ventral onlay FGU due to any circumstance (post-hoc exclusion). * Utilization of free graft material other than preputium, penile shaft skin, buccal mucosa or lingual mucosa. * Any condition or situation, which, in the investigator's opinion, puts the patient …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Failure-free survival after 24 months

Timeframe: 24 months

Trial details

NCT IDNCT04551417

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Contact for this trial

Nicolaas Lumen

+32 9 332 22 76 nicolaas.lumen@uzgent.be

View on ClinicalTrials.gov More Urethra Stenosis trials