DoVe Trial: Dorsal Onlay Versus Ventral Onlay in Isolated Bulbar Urethral Strictures (NCT04551417) | Clinical Trial Compass
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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 range18 Years
SexMALE
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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 …