VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
- Conditions
- SurgeryUrologic DiseasesUrethral Stricture
- Interventions
- Procedure: Vessel-sparing anastomotic repair (vsAR)Procedure: Transecting anastomotic repair (tAR)
- Registration Number
- NCT03572348
- Lead Sponsor
- University Hospital, Ghent
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vessel-sparing anastomotic repair (vsAR) 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. Transecting anastomotic repair (tAR) Transecting anastomotic repair (tAR) Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
- Primary Outcome Measures
Name Time Method FFS at 24 months 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
Name Time Method Erectile function 3, 12, and 24 months Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire
Quality of life (EQ-5D-3L) 3, 12, and 24 months QoL scored by the EQ-5D-3L questionnaire
FFS at 3 and 12 months 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.
Lower Urinary Tract symptoms 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)
Ejaculatory function 3, 12, and 24 months Ejaculatory function score assessed by the Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD short form)
Urinary incontinence 3, 12, and 24 months Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI)
Maximum flow rate 3, 12, and 24 months Qmax assessed using uroflowmetry
Residual urinary volumes 3, 12, and 24 months Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding
Quality of life (EQ-VAS) 3, 12, and 24 months QoL scored by the EQ visual analogue scale (EQ-VAS)
Voiding function 3, 12, and 24 months Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.
Trial Locations
- Locations (13)
Department of Urology, Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Dept. of Urology, University Hospital Leuven
🇧🇪Leuven, Belgium
Dept. of Urology, Ghent University Hospital
🇧🇪Ghent, Belgium
Department of Urology, Hospital de Santa María, Universidad de Lisboa
🇵🇹Lisboa, Portugal
Centro de Uretra Las Alamedas
🇲🇽Ciudad de mexico, Mexico
Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey
🇲🇽Monterrey, Mexico
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, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
🇨🇳Shanghai, China
Department of Urology, Centro de Educación Médica e Investigaciones Clínicas
🇦🇷Buenos Aires, Argentina
Dept. of Urology, Hospital Univ. de Valdecilla
🇪🇸Santander, Spain
Department of Urology, University College London Hospital
🇬🇧London, United Kingdom
Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe
🇪🇸Madrid, Spain