For bulbar urethral strictures, it remains unclear whether ventral onlay graft urethroplasty is non-inferior to dorsal onlay graft urethroplasty in terms of patency rates.
Urethral stricture disease is a common urological condition in men. Although rigorous epidemiologic data is sparse, the existing papers report an incidence varying between 0.6 and 1.4 percent1. Urethral strictures can occur throughout the entire length of the urethra, but mainly involve the anterior urethra and, in particular, the bulbar segment2. The International Consultation on Urologic Diseases (ICUD) recommends anastomotic repair (AR) urethroplasty for isolated, short, bulbar urethral strictures3. However, AR urethroplasty is only possible up to a certain point of stricture length. The elasticity of the bulbar urethra is estimated to be about 25% and given the average bulbar urethral length of 10 cm, one could simply calculate that strictures up to 2.5 cm can be treated with AR urethroplasty. However, this border of 2.5 cm is rather arbitrary as additional length may be gained through the different maneuvers of Webster et al., enabling the option of AR for even longer strictures4. Furthermore, the location of the stricture within the bulbar segment plays an important role as well: a proximal bulbar stricture location allows AR for longer strictured segments (\> 2.5 cm) than a more distal stricture location which nears the penoscrotal angle. Anyhow, the key for a successful AR procedure is to perform a well-vascularized and tension-free anastomosis5. Whenever this is impossible to achieve, even after performing the length-gaining maneuvers of Webster et al., it is recommended to perform a so-called 'substitution urethroplasty' in which the strictured area of the urethra is opened and augmented with a free graft or a pedicled flap5. Within the option of substitution urethroplasty, free graft urethroplasty (FGU) definitely represents the easiest and most straightforward treatment option. Herein, urethral surgeons initially started by placing grafts ventrally 'on' the urethra: 'ventral onlay FGU'. Later, Barbagli et al. started placing grafts dorsally: 'dorsal onlay FGU'6. They advocated that this dorsal graft position would lead to better graft anchorage, less graft mobility and less graft sacculation. However, to date, there is no indisputable data to support the choice of one technique over another, not from a surgical point of view, nor from a functional point of view7. Furthermore, studies investigating this issue are mostly retrospective and thus only entail a low level of evidence7. Against this background, the aim of the DoVe trial is to directly compare dorsal onlay and ventral onlay FGU for both surgical and functional outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
Free graft urethroplasty will be performed either with ventral or dorsal onlay of the graft.
Ghent University Hospital
Ghent, Belgium
RECRUITINGFailure-free survival after 24 months
Failure is defined as the inability to pass a flexible 16 Fr cystoscope through the reconstructed area without damaging the urethral mucosa.
Time frame: 24 months
Change in postoperative erectile function
Assessed with IIEF 5 questionnaire (international index on erectile function: score between 5 and 25, higher scores indicating better erectile function)
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in ejaculatory function
Assessed with MSHQ-EjD short form questionnaire (male sexual health questionnaire - ejaculatory dysfunction short form: score between 1 and 15, higher scores indicating better ejaculatory function)
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in LUTS
Assessed with Peeling's voiding picture (score between 1 and 4, lower scores indicating better strength of the urinary stream)
Time frame: Baseline question, followed by question at 3, 12 and 24 months of follow-up.
Change in LUTS
Assessed with ICIQ-MLUTS module (international consultation on incontinence questionnaire - male lower urinary tract symptoms: score between 0 and 24, higher scores indicating more LUTS)
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in urinary continence
Assessed with ICIQ-UI short form questionnaire (international consultation on incontinence questionnaire - urinary incontinence: score between 0 and 21, higher scores indicating more urinary incontinence)
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Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in maximum flow rate
Assessed with uroflowmetry (Qmax)
Time frame: Uroflowmetry at baseline, followed by uroflowmetry at 3, 12 and 24 months of follow-up.
Change in quality of life
Assessed with EQ-5D-3L (5 questions on quality of life resulting in digit score, e.g. 11231, higher scores indicating worse quality of life)
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Change in quality of life
Assessed with EQ-VAS (EQ-visual analogue scale: scale between 0 and 100, higher scores indicating better quality of life)
Time frame: Baseline questionnaire, followed by questionnaire at 3, 12 and 24 months of follow-up.
Patient satisfaction
Assessed with two general patient satisfaction questions
Time frame: Assessed after 3, 12 and 24 months of follow-up.
Postoperative complication rate
Categorized according to the Clavien-Dindo classification system
Time frame: Within 90 days postoperatively