We aim to describe the ProACT implantation using flexible cystoscopic guidance and to report long-term outcomes in these patients.
This single-centre retrospective study include all men who underwent ProACT™ for SUI after RP using flexible cystoscopic guidance between 2007 and 2021. The implantation was performed via a perineal approach under general or locoregional anaesthesia. Accurate positioning was ensured using both real-time fluoroscopic and endoscopic guidance (flexible cystoscopy retroflexed toward the bladder neck).
In total, 196 men were included; 18% (n = 36) had previously undergone radiotherapy and 24% (n = 46) had undergone SUI surgery. The median (IQR) follow-up time was 63 (24–108) months. At the last follow-up, 64% of participants still had their balloon in place, and the success and improvement rates were 62% and 17%, respectively. The perioperative complication rate was 5% (mainly bladder injury and acute urinary retention). Forty-two per cent (n = 82) experienced at least one complication, mainly device deflation (28%). Definitive explantation occurred in 36% (n = 71), with secondary implantation of an artificial urinary sphincter in 96% (n = 68).
ProACT® adjustable balloon implantation using flexible cystoscopic guidance appears to be an effective and safe long-term procedure for men with SUI after RP.