Clinical trial NCT03572348: VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
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
Overall status: COMPLETED
Phase: NA
Conditions: Urethral Stricture
Surgery
Urologic Diseases
Keywords: urethral stricture
urethroplasty
bulbar urethra
reconstructive surgery
lower urinary tract symptoms
erectile function
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, interventional, multicentric, single-blinded, randomized, controlled, non-inferiority, phase II trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: FFS at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: FFS at 3 and 12 months
timeFrame: 3 and 12 months
measure: Erectile function
timeFrame: 3, 12, and 24 months
measure: Ejaculatory function
timeFrame: 3, 12, and 24 months
measure: Voiding function
timeFrame: 3, 12, and 24 months
measure: Lower Urinary Tract symptoms
timeFrame: 3, 12, and 24 months
measure: Urinary incontinence
timeFrame: 3, 12, and 24 months
measure: Maximum flow rate
timeFrame: 3, 12, and 24 months
measure: Residual urinary volumes
timeFrame: 3, 12, and 24 months
measure: Quality of life (EQ-5D-3L)
timeFrame: 3, 12, and 24 months
measure: Quality of life (EQ-VAS)
timeFrame: 3, 12, and 24 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Department of Urology, SUNY Upstate Medical University
state: New York
city: Norfolk
country: United States
facility: Department of Urology, Eastern Virginia Medical School
state: Virginia
city: Buenos Aires
country: Argentina
facility: Department of Urology, Centro de Educación Médica e Investigaciones Clínicas
city: Buenos Aires
country: Argentina
facility: Department of Urology, Hospital Italiano de Buenos Aires
city: Ghent
country: Belgium
facility: Dept. of Urology, Ghent University Hospital
city: Leuven
country: Belgium
facility: Dept. of Urology, University Hospital Leuven
city: Shanghai
country: China
facility: Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
city: Ciudad de mexico
country: Mexico
facility: Centro de Uretra Las Alamedas
city: Monterrey
country: Mexico
facility: Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey
city: Lisboa
country: Portugal
facility: Department of Urology, Hospital de Santa María, Universidad de Lisboa
city: Madrid
country: Spain
facility: Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe
city: Santander
country: Spain
facility: Dept. of Urology, Hospital Univ. de Valdecilla
city: London
country: United Kingdom
facility: Department of Urology, University College London Hospital
Study officials:
References:
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