VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures. (VeSpAR)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    University Hospital, Ghent
Updated on 23 April 2022

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.

Description

A randomized controlled trial comparing vessel-sparing anastomotic repair (vsAR) and transecting anastomotic repair (tAR) in isolated short bulbar urethral strictures (maximum 3 centimeter) for both surgical and functional outcome, to demonstrate that vsAR is not inferior to tAR regarding the surgical outcome, and to demonstrate a benefit for vsAR over tAR regarding postoperative erectile function.

Details
Condition Urethral Stricture, Surgery, Urologic Diseases
Treatment Transecting anastomotic repair (tAR), Vessel-sparing anastomotic repair (vsAR)
Clinical Study IdentifierNCT03572348
SponsorUniversity Hospital, Ghent
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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, 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
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