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 range

18 Years

Sex

MALE

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, w…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

FFS at 24 months

Timeframe: 24 months

Trial details

NCT IDNCT03572348

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-14

View on ClinicalTrials.gov More Urethral Stricture trials