Comparing two surgical techniques for treating bulbar urethral strictures

DoVe Trial: a Randomized Controlled Trial Comparing Dorsal Onlay Versus Ventral Onlay in Isolated Bulbar Urethral Strictures

This study tests whether a new surgical method for fixing bulbar urethral strictures works just as well as the traditional method for men aged 18 and older.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University Hospital, Ghent (other)
• Drugs / interventions: radiation
• Locations: 1 site (Ghent)
• Trial ID: NCT04551417 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of dorsal onlay graft urethroplasty versus ventral onlay graft urethroplasty in treating isolated bulbar urethral strictures. The study aims to determine whether the ventral approach is non-inferior to the dorsal approach in terms of patency rates. Eligible male patients aged 18 and older with confirmed isolated bulbar urethral strictures will be recruited for the trial. Participants will undergo free graft urethroplasty and will be monitored for outcomes related to the success of the surgical technique.

Who should consider this trial

Good fit: Ideal candidates for this study are male patients aged 18 and older with isolated bulbar urethral strictures confirmed by imaging.

Not a fit: Patients with urethral strictures in locations other than the bulbar urethra or those who are unfit for surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective surgical technique for treating bulbar urethral strictures, potentially improving patient outcomes.

How similar studies have performed: While there is limited data on the comparative effectiveness of these two surgical techniques, similar studies have explored urethroplasty approaches, indicating potential for meaningful insights.

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.

Where this trial is running

Ghent

• Ghent University Hospital — Ghent, Belgium (RECRUITING)

Study contacts

• Principal investigator: Nicolaas Lumen — University Hospital, Ghent
• Study coordinator: Nicolaas Lumen

Conditions: Urethra Stenosis