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

Last updated: January 5, 2024
Sponsor: University Hospital, Ghent
Overall Status: Completed

Phase

N/A

Condition

Surgery

Enuresis

Peyronie's Disease

Treatment

Transecting anastomotic repair (tAR)

Vessel-sparing anastomotic repair (vsAR)

Clinical Study ID

NCT03572348
BC-03662
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntary signed written informed consent (according to the rules of Good ClinicalPractice 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 retrogradeurethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonographyor 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

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, membranousurethra, 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 andintracavernous injections) at the moment of prescreening for inclusion in this trial
  • Any condition or situation, which, in the investigator's opinion, puts the patient atsignificant risk, could confound the study results, or may interfere significantlywith the patient's participation in the study
  • Patient declares that it will be impossible for him to attend the follow-upconsultations

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Transecting anastomotic repair (tAR)
Phase:
Study Start date:
September 26, 2018
Estimated Completion Date:
December 14, 2023

Study 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.

Connect with a study center

  • Department of Urology, Centro de Educación Médica e Investigaciones Clínicas

    Buenos Aires,
    Argentina

    Site Not Available

  • Department of Urology, Hospital Italiano de Buenos Aires

    Buenos Aires,
    Argentina

    Site Not Available

  • Dept. of Urology, Ghent University Hospital

    Ghent, 9000
    Belgium

    Site Not Available

  • Dept. of Urology, University Hospital Leuven

    Leuven,
    Belgium

    Site Not Available

  • Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    Shanghai,
    China

    Site Not Available

  • Centro de Uretra Las Alamedas

    Ciudad de mexico,
    Mexico

    Site Not Available

  • Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey

    Monterrey,
    Mexico

    Site Not Available

  • Department of Urology, Hospital de Santa María, Universidad de Lisboa

    Lisboa,
    Portugal

    Site Not Available

  • Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe

    Madrid,
    Spain

    Site Not Available

  • Dept. of Urology, Hospital Univ. de Valdecilla

    Santander,
    Spain

    Site Not Available

  • Department of Urology, University College London Hospital

    London,
    United Kingdom

    Site Not Available

  • Department of Urology, SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Department of Urology, Eastern Virginia Medical School

    Norfolk, Virginia 23507-1912
    United States

    Site Not Available

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