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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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.
Department of Urology, SUNY Upstate Medical University
Syracuse, New York, United States
Department of Urology, Eastern Virginia Medical School
Norfolk, Virginia, United States
Department of Urology, Centro de Educación Médica e Investigaciones Clínicas
Buenos Aires, Argentina
Department of Urology, Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Dept. of Urology, Ghent University Hospital
Ghent, Belgium
Dept. of Urology, University Hospital Leuven
Leuven, Belgium
Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, China
Centro de Uretra Las Alamedas
Mexico City, Mexico
Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey
Monterrey, Mexico
Department of Urology, Hospital de Santa María, Universidad de Lisboa
Lisbon, Portugal
...and 3 more locations
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.
Time frame: 24 months
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.
Time frame: 3 and 12 months
Erectile function
Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire
Time frame: 3, 12, and 24 months
Ejaculatory function
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
Voiding function
Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.
Time frame: 3, 12, and 24 months
Lower Urinary Tract symptoms
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
Urinary incontinence
Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI)
Time frame: 3, 12, and 24 months
Maximum flow rate
Qmax assessed using uroflowmetry
Time frame: 3, 12, and 24 months
Residual urinary volumes
Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding
Time frame: 3, 12, and 24 months
Quality of life (EQ-5D-3L)
QoL scored by the EQ-5D-3L questionnaire
Time frame: 3, 12, and 24 months
Quality of life (EQ-VAS)
QoL scored by the EQ visual analogue scale (EQ-VAS)
Time frame: 3, 12, and 24 months
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