VeSpAR: A Randomized Controlled Trial Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Urethral Strictures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 100
- Locations
- 13
- Primary Endpoint
- FFS at 24 months
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations)
- •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
Arms & Interventions
Transecting anastomotic repair (tAR)
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
Intervention: Transecting anastomotic repair (tAR) (Procedure)
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.
Intervention: Vessel-sparing anastomotic repair (vsAR) (Procedure)
Outcomes
Primary Outcomes
FFS at 24 months
Time Frame: 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 Outcomes
- Quality of life (EQ-5D-3L)(3, 12, and 24 months)
- Lower Urinary Tract symptoms(3, 12, and 24 months)
- Residual urinary volumes(3, 12, and 24 months)
- FFS at 3 and 12 months(3 and 12 months)
- Erectile function(3, 12, and 24 months)
- Ejaculatory function(3, 12, and 24 months)
- Urinary incontinence(3, 12, and 24 months)
- Maximum flow rate(3, 12, and 24 months)
- Quality of life (EQ-VAS)(3, 12, and 24 months)
- Voiding function(3, 12, and 24 months)