Study design, materials and methods
An institutional retrospective review of all ARGUS® sling placements between March 2005 and September 2020 was performed. A “fragile urethra” was defined as a history of pelvic radiation, previous incontinence surgeries, previous urethroplasty or procedures for bladder neck pathologies. The primary outcome was continence, secondary outcomes included postoperative complications, need for further treatment and patients reported satisfaction. Success was defined as a reduction of more than 50% in pad per day usage (p/d).
Retrograde Leak Point Pressure (RLPP) was measured intraoperatively at baseline (before sling placement), after sling placement and the sling was progressively adjusted by tensioning the silicone columns through the washers. The RLPP was generally adjusted 10-15 cmH2O higher than the reference RLPP measured initially before sling placement.
Results
Within the observation period Argus® sling was indicted in 122 men with moderate to severe urinary incontinence (defined as pad per day usage ≥2) . 69 of 122 patients (56,6%) were identified as having a fragile urethra. 16 patients (23,2%) had a history of pelvic radiation, 23 (33,3%) had a previous incontinence surgery, mostly ProACT Balloons (n=18). In 15 cases (21,7%) prior procedures for bladder neck pathologies were performed and other 15 (21,7%) had multiple risk factors for erosion. The success-rate was reported as 76,5% and 44 patients (63,8%) were socially dry (≤ 1p/d). The p/d improved in average from 3.7 (±1.7) to 1.5 (±1,4) and 90% reported a significant improvement regarding continence and quality of life (QoL).
Complications included postoperative hematoma (n=4), transient perineal or scrotal pain (n=5), which were treated conservatively. Urethral erosion and infection were reported in 10 cases (erosion n=6 and infection=4).
Sling explantation was reported in 28 cases after a median of 41 months (range 1.4-164.8 months), mostly associated with persistence urinary incontinence (n=18) or urethral erosion (n=6).
Interpretation of results
Although the higher risk for failure in this cohort of patient, the success rate with 77% was consistent with the evidence in literature and confirm the effectiveness of Argus® even in men with higher risk for erosion. Patient’s reported satisfaction was 90%, which is at and even above the upper limit in comparison to literature.