Hypothesis / aims of study
According to the SATURN registry [1] adjustable systems such as, Argus, Atoms and ProAct, roughly represent 10% of surgeries for male incontinence. Limitations can be the way of adjustment, insufficient contact to the urethra or simply unsatisfactory continence results. Vulko is a new adjustable sling that provides a direct upright vector for urethral coaptation and easy percutaneous adjustment, resulting in consistent resistance when needed.
The primary aim is to present the preliminary results in terms of continence with the first implantations of this new device. The secondary aim is in terms of early complications.
Study design, materials and methods
We present the first reported use of the Vulko system (Promedon, Argentina) in eight patients with moderate-to-severe stress urinary incontinence. These were carried out from September 2022 to February 2023 in three surgical centers.
The VULKO Adjustable Suburethral System treats male stress urinary incontinence as a permanent silicone implant with an inflatable pad (A) and a self-sealing scrotal port (B) for fluid injection. The sling includes two fixation arms with semi-cone sections for anchoring (C), two green connector arms (D), and two protective sheaths (E) (Figure 1). The set includes one pair of radiopaque washers for surgical adjustment and a retropubic instrument (Figure 2).
Surgical technique description: a small vertical incision was made over the urethral bulb, and the triangular space between the bulb and ischiopubic ramus was dissected. Two transverse suprapubic incisions were made. A syringe filled with sterile saline solution was used to inject 5 ml of fluid into the device, removing any air bubbles. The pad is filled with this amount of liquid in order to achieve direct contact with the bulbospongiosus muscle. The retropubic instrument was inserted through the perineal incision and advanced to the suprapubic incision. A cystoscopy was performed, and the optic and camera were removed, leaving the cystoscope sheath in place to perform the positioning and intraoperative adjustment of the sling. The green connector arms were pulled out until the pad touches the bulbospongiosus muscle, and then cut below the white cone of the fixation arms. The protective sheets were removed. Both washers were attached to the fixations arms and pulled down until they snugly fit the rectus fascia. The tips of the fixation arms were bent and passed through the second hole of the washer aiming to the midline. The self-sealing port of the VULKO was punctured with a non-coring needle, and 3 ml of solution was removed, leaving 2 ml in the pad. A scrotal subcutaneous pouch was created on the left side of the patient, and the port was placed inside it. Finally, the incisions were closed.
The information was collected from each of the responsible surgeons regarding the following parameters: surgery date, duration, preoperative continence level in pads per day, postoperative continence level in pads per day, during the following time intervals: 1-10 days, 10-30 days, 30-60 days, 60-180 days. Postoperative symptoms, adverse events, and ambulatory adjustments were also recorded.
The continence rate was assessed by the quantity of pre and postoperative pads used, and postoperative complications according to the Clavien-Dindo classification (CDC).
Results
All patients presented moderate to severe stress urinary incontinence (3-5 pads per day). The interventions lasted an average 55 minutes (41-73 minutes). No serious complications were observed in the immediate intraoperative and postoperative period. A foley catheter was left for two nights.
Patients exhibited symptoms including dysuria (3 cases), weak urine stream (6 cases), perineal pain (8 cases managed with oral medication), and urinary retention (2 cases where a foley catheter had to be re-introduced for 10 days). All the postoperative complications mentioned above are classified as CDC grade 1.
Ambulatory adjustments were performed after one month in two patients, with 2 and 3mL respectively, achieving continence afterward.
With an average follow-up of 4.3 months (2-7 months), continence was achieved for all patients without needing pad usage.
Interpretation of results
According to the obtained preliminary results, the adjustable Vulko sling achieves a high continence rate comparable to the devices available on the market to date for the treatment of moderate-to-severe male stress urinary incontinence, with a low rate of adverse events and being of low complexity.