VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
Completed · Not applicable
Conditions studied: Urethral Stricture, Surgery, Urologic Diseases
In brief
The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Furthermore, the investigators compare the functional outcome of both techniques verifying if there is less erectile dysfunction after vessel-sparing anastomotic repair than after transecting anastomotic repair.
Key facts
- Study ID
- NCT03572348
- Run by
- University Hospital, Ghent
- People needed
- 100
- Starts
- 2018-09-26
- Expected to finish
- 2023-12-14
- Last updated by the study team
- 2024-01-08
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations)
- Male
- Age >= 18 years
- Fit for operation, based on the surgeon's expert opinion
- Isolated short (=< 3cm) bulbar urethral stricture confirmed by preoperative retrograde urethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonography or a combination of investigations
- Unique urethral stricture
- Urethral stricture =< 3 cm
- Urethral stricture at the bulbar segment
- Patient declares that it will be possible for him to attend the follow-up consultation
You may not qualify if…
- Absence of signed written informed consent
- 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)
- Urethral strictures exceeding 3 cm
- A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
- Lichen Sclerosus related strictures
- Strictures after failed hypospadias repair
- Patients with neurogenic bladder
- Shift of technique to augmented urethroplasty due to any circumstance
- History of pelvic radiation therapy
- Active treatment to enhance erectile function (such as PDE5-inhibitors and intracavernous injections) at the moment of prescreening for inclusion in this trial
- 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 it is running
- Department of Urology, SUNY Upstate Medical University — Syracuse, New York, United States
- Department of Urology, Eastern Virginia Medical School — Norfolk, Virginia, United States
- Department of Urology, Centro de Educación Médica e Investigaciones Clínicas — Buenos Aires, Argentina
- Department of Urology, Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
- Dept. of Urology, Ghent University Hospital — Ghent, Belgium
- Dept. of Urology, University Hospital Leuven — Leuven, Belgium
- Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital — Shanghai, China
- Centro de Uretra Las Alamedas — Mexico City, Mexico
- Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey — Monterrey, Mexico
- Department of Urology, Hospital de Santa María, Universidad de Lisboa — Lisbon, Portugal
- Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe — Madrid, Spain
- Dept. of Urology, Hospital Univ. de Valdecilla — Santander, Spain
- Department of Urology, University College London Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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