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NCT Number: NCT03572348

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

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Key information

Conditions

Urethral Stricture Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery Urethral Diseases Urethral Obstruction Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Centro de Educación Médica e Investigaciones Clínicas, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transecting anastomotic repair (tAR)

Procedure

Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.

Vessel-sparing anastomotic repair (vsAR)

Procedure

Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Erectile function

    Time frame: 3, 12, and 24 months

    Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire

  3. 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)

  4. Voiding function

    Time frame: 3, 12, and 24 months

    Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.

  5. 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)

  6. 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)

  7. Maximum flow rate

    Time frame: 3, 12, and 24 months

    Qmax assessed using uroflowmetry

  8. Residual urinary volumes

    Time frame: 3, 12, and 24 months

    Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding

  9. Quality of life (EQ-5D-3L)

    Time frame: 3, 12, and 24 months

    QoL scored by the EQ-5D-3L questionnaire

  10. Quality of life (EQ-VAS)

    Time frame: 3, 12, and 24 months

    QoL scored by the EQ visual analogue scale (EQ-VAS)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: VeSpAR

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2018
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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