VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolate⦠(NCT03572348) | Clinical Trial Compass
CompletedNot Applicable
VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
United States, Argentina, Belgium100 participantsStarted 2018-09-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexMALE
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:
* 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
Exclusion Criteria:
* 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, wā¦