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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Urethral Stricture; Surgery; Urologic Diseases

Treatments: Procedure: Transecting anastomotic repair (tAR); Procedure: Vessel-sparing anastomotic repair (vsAR)

Study type: Interventional

Funder types: Other

Identifiers

NCT03572348

BC-03662

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Transecting anastomotic repair (tAR)

Active Comparator group

Description:

Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.

Treatment:

Procedure: Transecting anastomotic repair (tAR)

Vessel-sparing anastomotic repair (vsAR)

Active Comparator group

Description:

Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.

Treatment:

Procedure: Vessel-sparing anastomotic repair (vsAR)