Adjustable continence therapy (ProACT™) after male sling failure for patients with post-radical prostatectomy urinary incontinence: a prospective study with one-year follow-up.

Abstract

To assess the effects of the ProACT™ device as a second-line treatment for persistent incontinence after male sling insertion. Twenty consecutive patients were treated with the ProACT™ device due to persistent urinary incontinence following male sling insertion (9 AdVance™, 9 TOMS™, 2 InVance™). All balloons were implanted using a combination of fluoroscopic imaging and fibroscopic retrovision. Urinary symptoms were assessed prior to male sling insertion (T0) and before (T1) and 1 year after the ProACT™ insertion (T2) using questionnaires (ICIQ, USP, and ULCA-PCI-urinary bother) and by determining the number of pads used daily. The mean age of the study population at T1 was 68.6 ± 9 years. The mean volume of adjustment at T2 was 4.5 ± 2.7 mL. The previous sling did not cause any technical difficulties during ProACT™ insertion. Late wound infections occurred in the two patients who had been previously treated with the InVance sling and required removal of all implanted materials (Clavien-Dindo classification IIIb). Improvement in mean urinary scores was noted in the remaining patients (n = 18) through T0, T1, and T2, respectively: The ICIQ scores were 16.8 ± 2.6, 13.1 ± 3.4, and 5.7 ± 5.7 (P < 0.0001); USP stress urinary incontinence scores were 8 ± 1.8, 5.6 ± 2.2, and 2.4 ± 2.8, (P < 0.0001); USP overactive bladder symptom scores were 6.8 ± 4.3, 7.6 ± 4.3, and 4.1 ± 3.5 (P = 0.008), UCLA-PCI urinary bother scores were 7.1 ± 11.3, 28.6 ± 12.9, and 69.6 ± 31.6 (P < 0.0001), and number of pads used were 2.9 ± 1, 2 ± 1, and 0.3 ± 0.9 (P < 0.0001). USP obstructive symptoms were 0.4 ± 1, 1 ± 1.6, and 1.3 ± 1.4 (P = 0.19). The Pro-ACT™ device may provide additional benefits for improving continence in case of persistent incontinence following male sling insertion.