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

January 5, 2024 updated by: University Hospital, Ghent

VeSpAR: A Randomized Controlled Trial Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Urethral Strictures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Department of Urology, Centro de Educación Médica e Investigaciones Clínicas
      • Buenos Aires, Argentina
        • Department of Urology, Hospital Italiano de Buenos Aires
  • Belgium
      • Ghent, Belgium, 9000
        • Dept. of Urology, Ghent University Hospital
      • Leuven, Belgium
        • Dept. of Urology, University Hospital Leuven
  • China
      • Shanghai, China
        • Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Mexico
      • Ciudad de mexico, Mexico
        • Centro de Uretra Las Alamedas
      • Monterrey, Mexico
        • Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey
  • Portugal
      • Lisboa, Portugal
        • Department of Urology, Hospital de Santa María, Universidad de Lisboa
  • Spain
      • Madrid, Spain
        • Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe
      • Santander, Spain
        • Dept. of Urology, Hospital Univ. de Valdecilla
  • United Kingdom
      • London, United Kingdom
        • Department of Urology, University College London Hospital
  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • Department of Urology, SUNY Upstate Medical University
    • Virginia
      • Norfolk, Virginia, United States, 23507-1912
        • Department of Urology, Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transecting anastomotic repair (tAR)
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
Procedure: Transecting anastomotic repair (tAR)
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
Active Comparator: Vessel-sparing anastomotic repair (vsAR)
Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.
Procedure: Vessel-sparing anastomotic repair (vsAR)
Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FFS at 24 months
Time Frame: 24 months
Failure-free survival at 24 months. Surgical failure is defined as urethroscopic evidence of stricture recurrence, impossible to pass with a 16Fr silicone urethral catheter, independent of whether the stricture is treated or not.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FFS at 3 and 12 months
Time Frame: 3 and 12 months
Failure-free survival at 3 and 12 months. Surgical failure is defined as urethroscopic evidence of stricture recurrence, impossible to pass with a 16Fr silicone urethral catheter, independent of whether the stricture is treated or not.
3 and 12 months
Erectile function
Time Frame: 3, 12, and 24 months
Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire
3, 12, and 24 months
Ejaculatory function
Time Frame: 3, 12, and 24 months
Ejaculatory function score assessed by the Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD short form)
3, 12, and 24 months
Voiding function
Time Frame: 3, 12, and 24 months
Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.
3, 12, and 24 months
Lower Urinary Tract symptoms
Time Frame: 3, 12, and 24 months
Lower Urinary Tract symptoms assessed by the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms module (ICIQ-MLUTS)
3, 12, and 24 months
Urinary incontinence
Time Frame: 3, 12, and 24 months
Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI)
3, 12, and 24 months
Maximum flow rate
Time Frame: 3, 12, and 24 months
Qmax assessed using uroflowmetry
3, 12, and 24 months
Residual urinary volumes
Time Frame: 3, 12, and 24 months
Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding
3, 12, and 24 months
Quality of life (EQ-5D-3L)
Time Frame: 3, 12, and 24 months
QoL scored by the EQ-5D-3L questionnaire
3, 12, and 24 months
Quality of life (EQ-VAS)
Time Frame: 3, 12, and 24 months
QoL scored by the EQ visual analogue scale (EQ-VAS)
3, 12, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2018

Primary Completion (Actual)

December 14, 2023

Study Completion (Actual)

December 14, 2023

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-03662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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