Surgery, Urethral Stricture, Urologic Diseases
Conditions
Keywords
urethral stricture, urethroplasty, bulbar urethra, reconstructive surgery, lower urinary tract symptoms, erectile function
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.
Interventions
PROCEDURETransecting anastomotic repair (tAR)
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
PROCEDUREVessel-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.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
Prospective, interventional, multicentric, single-blinded, randomized, controlled, non-inferiority, phase II trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (EQ-VAS) | 3, 12, and 24 months | QoL scored by the EQ visual analogue scale (EQ-VAS) |
| 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. |
| Erectile function | 3, 12, and 24 months | Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire |
| 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) |
| Quality of life (EQ-5D-3L) | 3, 12, and 24 months | QoL scored by the EQ-5D-3L questionnaire |
| 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) |
| 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 |
| Voiding function | 3, 12, and 24 months | Lower Urinary Tract symptoms assessed by the Peeling's voiding picture. |
Countries
Argentina, Belgium, China, Mexico, Portugal, Spain, United Kingdom, United States
Outcome results
None listed