RESUMO
OBJECTIVE: The objective of this study was to assess the mid-term efficacy and safety of adjustable continence therapy (ProACT™) for the treatment of male stress urinary incontinence (SUI) after radical prostatectomy (RP). PATIENTS AND METHODS: Single-center retrospective study including male patients implanted with ProACT™ periurethral balloons for SUI after RP between 2007 and 2017, mainly with flexible cystoscopic guidance. Efficacy was assessed using a composite endpoint with subjective (patient's impression of improvement (PII), using a 0-100 numeral rating scale) and objective outcomes (decrease in daily pad use). Postoperative success was defined as a PII ≥ 80%, associated with the use of 0-1 pad daily. Improvement was defined as a PII ≥ 50% and a decrease ≥50% in the number of daily pads used. RESULTS: Two hundred men with a median age of 68 (64-73) years were included. Seventeen percent (n = 34) had had prior radiotherapy and 15.5% (n = 31) had had prior SUI surgery. The median follow-up was 43 (19-71) months. The severity of SUI was as follows: mild in 119 (59.5%), moderate in 48 (24%), and severe in 33 patients (16.5%). Severe SUI and a history of prior radiotherapy were associated with a lower success rate (p = 0.033 and p < 0.0001). The overall reoperation rate was 34%, with 5.6% (n = 11) requiring a third implantation. Of the patients, 29.4% (n = 58) required an artificial urinary sphincter to treat SUI. At the last follow up, among the overall population, the success rate was 40.1% and the median PII was 18.3%. For patients in whom the balloons were still in place (n = 132), the cumulative success and improvement rate was 78%, with a median PII of 72%. CONCLUSION: The minimally invasive ProACT™ device provides a clear beneficial continence outcome in patients with SUI after radical prostatectomy. Severe SUI or prior radiotherapy were associated with a lower success rate in our study.