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

Study Overview
=================
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.

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

Conditions
-----------------
Urethral Stricture, Surgery, Urologic Diseases

Intervention / Treatment
-----------------
* Procedure: Transecting anastomotic repair (tAR)
* Procedure: Vessel-sparing anastomotic repair (vsAR)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, interventional, multicentric, single-blinded, randomized, controlled, non-inferiority, phase II trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transecting anastomotic repair (tAR)<br>Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply. | Procedure: Transecting anastomotic repair (tAR)<br>* Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.<br>|
| Active Comparator: Vessel-sparing anastomotic repair (vsAR)<br>Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis. | Procedure: Vessel-sparing anastomotic repair (vsAR)<br>* Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 and 12 months | 
| Erectile function | Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire | 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) | 3, 12, and 24 months | 
| Voiding function | Lower Urinary Tract symptoms assessed by the Peeling's voiding picture. | 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) | 3, 12, and 24 months | 
| Urinary incontinence | Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI) | 3, 12, and 24 months | 
| Maximum flow rate | Qmax assessed using uroflowmetry | 3, 12, and 24 months | 
| Residual urinary volumes | Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding | 3, 12, and 24 months | 
| Quality of life (EQ-5D-3L) | QoL scored by the EQ-5D-3L questionnaire | 3, 12, and 24 months | 
| Quality of life (EQ-VAS) | QoL scored by the EQ visual analogue scale (EQ-VAS) | 3, 12, and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urethral stricture, urethroplasty, bulbar urethra, reconstructive surgery, lower urinary tract symptoms, erectile function