Study design, materials and methods
The Sling was indicated in 117 patients within the observation period, there were lacking data regarding RLPP, postoperative micturition or residual volume, so 24 patients were excluded.
The data of 93 patients (average age 70 years) with moderate-to-severe SUI who underwent implantation of male Argus® sling between 3/2006- 9/2020 were retrospectively analyzed.
RLPP was measured intraoperatively, and the sling was progressively adjusted by tensioning the silicone columns through the washers as described by Romano et al. in 20061. RLPP measurement was performed at baseline (before sling positioning) and after tensioning the sling but before closing the incision.
Results
The average intraoperative baseline RLPP was 22.7 cmH2O and was generally adjusted 10-15 cmH2O higher than the reference RLPP measured initially before sling placement (range 20-47 cmH2O; median 28).
The cure rate was 80% (defined as reduction of p/d of ≥ 50%), in a mean follow-up of 92 months. Temporary urinary retention occurred in 12 cases (12,9%) and was resolved conservatively by placing a transurethral catheter for 1 week, only in one case loosening of the sling was required.
The postoperative uroflow studies showed in median Qmax of 13,5 ml/sec, only in 5 cases (5,4%) an incomplete emptying of the bladder with residual urine >40 ml (range 40-170ml) was reported.
Erosion was reported in 9 (9,7%) cases after a median FU of 57.6 months.
For validation purposes, we did subgroup analysis and compared the results of the patients with different RLPP. There were 8, 53 and 32 patients in the subgroups with RLPP 15-25, 26-35 and >35cmH2O respectively. In der subgroup analysis high RLPP>35cm H2O correlated significantly with explantation of the device (p=0.026).
Interpretation of results
Adjusting the RLPP of 10-15 cmH2O over the reference RLPP lead to positive outcomes for Argus sling with 80% cure rate and an acceptable erosion rate (10%). In our cohort an increase of RLPP to more than 35 cmH2O was an independent risk factor for urethral erosion.