Study design, materials and methods
In this retrospective cohort study we included male patients who had an anti-incontinence device implantation between July 2010 and August 2017. Two different prostheses were used: the AMS800Ⓡ AUS (Boston Scientific, Marlborough, USA) and the ArgusⓇ Sling (Promedon, Cordoba, Argentina). Mild incontinence was defined as the use of 1 pad per day, moderate incontinence as the use of 2 - 4 pads per day and severe incontinence as ≥5 pads per day. Primary endpoint was success rate, which was defined as those patients who became completely dry or used 1 small safety pad per day after surgery. Secondary endpoints included zero-pad rate (completely dry patients), pad-use decrease (difference between preoperative and postoperative pad-use rate), postoperative pain (patient referring pelvic pain 7 days after surgery), need for readjustment or reoperation and explantation rate.
Results
A total of 54 patients received an anti-incontinence device. Median age was 68 years old (range 35 - 81) and median follow-up was 18 months (range 6 - 84). The cause of UI was 61% post-prostatectomy, 13% post-adenomectomy, and 11% post-TURP. The remaining cases (15%) were of traumatic, neurogenic or post-radiotherapy etiology. One half of patients presented with severe UI and AUS patients presented more severe UI than sling patients (70% versus 40% respectively, chi2 p= 0.04). Thirty seven patients received a male sling and 17 an AUS. Global success rate was 68.5%, male sling success rate was 62% and AUS success rate was 76% (chi2 p 0.46). Zero pad-use rate was significantly higher in AUS patients, 53% versus 22% respectively (chi2 p 0.021). The same trend was found in pad-use decrease, being 5 (range 0-10) for AUS patients and 3 (Range 0-10) for male sling patients (Mann Whitney p 0.009). Postoperative pain was significantly higher in the male sling group (chi2 p 0.015), and led to sling explantation in 6 cases. Thirty-five secondary procedures were performed on 32 men (59%). Male sling patients required significantly more procedures than AUS patients (88% versus 12% respectively, chi2 p 0.002). These procedures included 19 sling readjustments, 12 sling explants, 3 AUS explants and 1 AUS revision for mechanical failure. Median time to explantation was 9 months (range 2 - 69).
Interpretation of results
Success rates did not differ significantly between patients who received a male sling or an AUS, but AUS patients had significantly higher zero-pad rate and pad-use decrease, with significantly less postoperative pain and need for secondary procedures, providing a higher impact on UI control.