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

Launched by UNIVERSITY HOSPITAL, GHENT · Sep 15, 2020

Keywords

ClinConnect Summary

The DoVe Trial is studying two different surgical methods for treating a condition called bulbar urethral stricture, which is a narrowing of the urethra that can cause problems with urination. Specifically, the trial compares two types of graft techniques: dorsal onlay (where the graft is placed on the top side of the urethra) and ventral onlay (where the graft is placed on the underside). Researchers want to find out if one method works just as well as the other in keeping the urethra open after surgery.

To participate in this trial, you need to be a male aged 18 or older who has been diagnosed with an isolated bulbar urethral stricture confirmed by imaging tests. You should be in good health and fit for surgery based on your doctor's assessment. If you join the study, you will have the surgery and then attend follow-up appointments to monitor your recovery and the success of the procedure. It's important to commit to these follow-ups to help the researchers gather the necessary information. This trial is currently looking for volunteers, so if you think you might be eligible, consider discussing it with your healthcare provider.

Gender

MALE

Eligibility criteria

• 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 at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
• • Patient declares that it will be impossible for him to attend the follow-up consultations.