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

Primary Purpose

Urethral Stricture, Surgery, Urologic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transecting anastomotic repair (tAR)
Vessel-sparing anastomotic repair (vsAR)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urethral Stricture focused on measuring urethral stricture, urethroplasty, bulbar urethra, reconstructive surgery, lower urinary tract symptoms, erectile function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Urology, SUNY Upstate Medical UniversityRecruiting
  • Department of Urology, Eastern Virginia Medical SchoolRecruiting
  • Department of Urology, Centro de Educación Médica e Investigaciones ClínicasRecruiting
  • Department of Urology, Hospital Italiano de Buenos AiresRecruiting
  • Dept. of Urology, Ghent University HospitalRecruiting
  • Dept. of Urology, University Hospital Leuven
  • Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Centro de Uretra Las AlamedasRecruiting
  • Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de MonterreyRecruiting
  • Department of Urology, Hospital de Santa María, Universidad de LisboaRecruiting
  • Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de GetafeRecruiting
  • Dept. of Urology, Hospital Univ. de Valdecilla
  • Department of Urology, University College London Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transecting anastomotic repair (tAR)

Vessel-sparing anastomotic repair (vsAR)

Arm Description

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

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

Outcomes

Primary Outcome Measures

FFS at 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 Outcome Measures

FFS at 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.
Erectile function
Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire
Ejaculatory function
Ejaculatory function score assessed by the Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD short form)
Voiding function
Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.
Lower Urinary Tract symptoms
Lower Urinary Tract symptoms assessed by the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms module (ICIQ-MLUTS)
Urinary incontinence
Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI)
Maximum flow rate
Qmax assessed using uroflowmetry
Residual urinary volumes
Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding
Quality of life (EQ-5D-3L)
QoL scored by the EQ-5D-3L questionnaire
Quality of life (EQ-VAS)
QoL scored by the EQ visual analogue scale (EQ-VAS)

Full Information

First Posted
June 5, 2018
Last Updated
January 3, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03572348
Brief Title
VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
Acronym
VeSpAR
Official Title
VeSpAR: A Randomized Controlled Trial Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Urethral Strictures
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture, Surgery, Urologic Diseases
Keywords
urethral stricture, urethroplasty, bulbar urethra, reconstructive surgery, lower urinary tract symptoms, erectile function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, interventional, multicentric, single-blinded, randomized, controlled, non-inferiority, phase II trial
Masking
Participant
Masking Description
Patients will be randomized using software in a 1:1 ratio in either the vessel-sparing group or the transecting group. Randomisation will be stratified per participating center and single blinded; double blindation is impossible as the surgeon has to know which technique to perform.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transecting anastomotic repair (tAR)
Arm Type
Active Comparator
Arm Description
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
Arm Title
Vessel-sparing anastomotic repair (vsAR)
Arm Type
Active Comparator
Arm Description
Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.
Intervention Type
Procedure
Intervention Name(s)
Transecting anastomotic repair (tAR)
Intervention Description
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
Intervention Type
Procedure
Intervention Name(s)
Vessel-sparing anastomotic repair (vsAR)
Intervention Description
Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.
Primary Outcome Measure Information:
Title
FFS at 24 months
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
FFS at 3 and 12 months
Description
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.
Time Frame
3 and 12 months
Title
Erectile function
Description
Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire
Time Frame
3, 12, and 24 months
Title
Ejaculatory function
Description
Ejaculatory function score assessed by the Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD short form)
Time Frame
3, 12, and 24 months
Title
Voiding function
Description
Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.
Time Frame
3, 12, and 24 months
Title
Lower Urinary Tract symptoms
Description
Lower Urinary Tract symptoms assessed by the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms module (ICIQ-MLUTS)
Time Frame
3, 12, and 24 months
Title
Urinary incontinence
Description
Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI)
Time Frame
3, 12, and 24 months
Title
Maximum flow rate
Description
Qmax assessed using uroflowmetry
Time Frame
3, 12, and 24 months
Title
Residual urinary volumes
Description
Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding
Time Frame
3, 12, and 24 months
Title
Quality of life (EQ-5D-3L)
Description
QoL scored by the EQ-5D-3L questionnaire
Time Frame
3, 12, and 24 months
Title
Quality of life (EQ-VAS)
Description
QoL scored by the EQ visual analogue scale (EQ-VAS)
Time Frame
3, 12, and 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolaas Lumen, MD, PhD
Phone
+3293322276
Email
nicolaas.lumen@uzgent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Wesley Verla, MD
Phone
+32498083423
Email
wesley.verla@uzgent.be
Facility Information:
Facility Name
Department of Urology, SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitriy Nikolavsky
Facility Name
Department of Urology, Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramon Virasoro
First Name & Middle Initial & Last Name & Degree
Jessica DeLong
Facility Name
Department of Urology, Centro de Educación Médica e Investigaciones Clínicas
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leandro Capiel
Facility Name
Department of Urology, Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Giudice
Facility Name
Dept. of Urology, Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wesley Verla, MD
First Name & Middle Initial & Last Name & Degree
Nicolaas Lumen, MD, PhD
Facility Name
Dept. of Urology, University Hospital Leuven
City
Leuven
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Joniau
Facility Name
Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lujie Song
Facility Name
Centro de Uretra Las Alamedas
City
Ciudad de mexico
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erick Ramirez
Facility Name
Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey
City
Monterrey
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Suarez
Facility Name
Department of Urology, Hospital de Santa María, Universidad de Lisboa
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Martins
Facility Name
Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Angulo
Facility Name
Dept. of Urology, Hospital Univ. de Valdecilla
City
Santander
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Félix Campos
Facility Name
Department of Urology, University College London Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamsin Greenwell

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Citation
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VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.

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