V02-10: Long term evaluation of the Argus-T&[reg] adjustable male sling: A prospective study

Rafael Zanotti*, André Costa Matos, Felipe Pinho, Claudio Hideki Toi, Sergio Paolillo, Giovani Demartino, Marcel Takada, Bruno Hirata, Luís Gustavo Morato de Toledo, São Paulo, Brazil

Introduction: Male slings are attractive alternatives for the treatment of post prostatectomy urinary incontinence(PPI). 
In this study and accompanying video, our purpose is to report our findings of up to 12 years of follow up and the technical details that led us to our results.

Methods: From 06/2009 to 09/2021, 89 patients with PPI underwent male Argus-T® adjustable sling implantation. We prospectively recorded their data.
Prior to implantation and during follow up, patients were acessed through clinical evaluation, 24h pad-test, ICIQ-SF and complications. Clinical and urodynamic variables were correlated to the need for readjustments.
Success was defined by cure or improvement.
The definition of objective cure was dry patient; of improvement, decrease >50% number of pads; of fail, decrease <50% number of pads.
The definition of subjective cure was VAS >=8 and PGI-I “much better”; of improvement, VAS 6-7 and PGI-I “little better”; of fail, VAS <=5 or unchanged.

Results: The median follow up was 96 (13 - 144) months. In our series 22 patients (24,6%) had mild, 23 (26,1%) moderate and 44 (49,3%) severe incontinence.
20 patients (22,5%) had received previous radiotherapy and 18 (19,7%) previous urethral stricture treatment.
Within the whole series,  75 patients (85,4%) achieved subjective success (74,4% cure + 11% improvement) and 71 (80,5%) objective success (65,9% cure + 14,6% improvement).
Readjustments were necessary in 23 (25,8%) cases.
Considering only the subgroups of patients who received previous radiotherapy and/or previous urethral stricture treatment, 66,7% needed readjustments. We found that these are predictor factors for the need of readjustments (p 0,001).
Complications included: 2 cases of protusion of silicon arms to the scrotal skin; 2 of inguinal granuloma. 7 cases of urinary retention that resolved with indwelling catheter for 7 to 10 days.
Device removal was necessary in 5 cases, 4 due to infection and 1 due to persistent urinary retention and severe pain. No cases of device components explantation were reported. Curiously, 3 of the 5 patients who had their devices removed remained dry, removal occurred about 2 years after surgery.

Conclusions: We found similar success rates than previously published for this device, however adverse events are lower, especially regarding to sling removal.
Previous radiotherapy and urethral stricture treatment are predictor factors for the need for readjustments.
Adjustability benefits a significant number of patients who would have failed. Especially those with worse prognostic factors; maintaining the success rates of this group similar to the group without these factors.
Argus-T has high and maintained success rate. Good outcomes can be achieved even for moderate to severe incontinence cases.

Source of Funding: None