The ‘ventral urethral elevation plus’ sling: a novel approach to treating stress urinary incontinence in men

OBJECTIVE To evaluate the urodynamic changes after placing a novel ‘ventral urethral elevation plus’ (VUE+) sling (LeveraTM, Caldera Medical, Agoura Hills, CA, USA) in a cadaveric study, and in our initial experience in two patients. PATIENTS, MATERIALS AND METHODS In two male cadavers (A and B) the maximum urethral closure pressure (MUCP) and retrograde leak‐point pressure (RLPP) were measured before and after transperineal placement of the Levera sling. A 5.5 × 7 cm sling, with two 1.5 × 22.5 cm inferior extensions and two 1.5 × 25 cm superior extensions, was placed over the bulbar urethra. The inferior extensions were passed using the transobturator approach, and the superior extensions by a prepubic approach. This procedure was offered to two men (C and D) with severe neurogenic intrinsic sphincter deficiency. RESULTS The mean baseline MUCP in specimen A was 55 cmH2O and the RLPP 35 cmH2O; after placing the sling the respective values increased to 75 and 70 cmH2O. In specimen B the respective mean values were 56 and 50 cmH2O, and after placing the sling were 82 and 75 cmH2O. In patient C, the RLPP increased from 17 cmH2O before surgery to 65 cmH2O afterward, and in patient D, from 20 to 70 cmH2O. At the 12‐month follow‐up, there was complete resolution of urinary incontinence in both patients. CONCLUSIONS The VUE+ Levera sling provides urethral compression against the perineal membrane using a straightforward pre‐pubic approach, and ventral elevation and compression of the bulbous urethra using the transobturator approach, avoiding the risks associated with of bone screws and retropubic needle passage. In our initial two patients stress incontinence was cured at 1 year of follow‐up. A long‐ term follow‐up and a larger prospective study of the VUE+ sling is needed to objectively assess the efficacy of this novel procedure.