Efficacy of Pressure Regulating Balloon Exchange in Men With Post Artificial Urinary Sphincter Persistent or Recurrent Stress Urinary Incontinence.

ABSTRACT

OBJECTIVE: To assess the efficacy of exchanging the pressure regulating balloon (PRB) to 71-80 cm H2O in patients with persistent or recurrent stress urinary incontinence (SUI) following artificial urinary sphincter (AUS) placement. METHODS: Patients with SUI following AUS placement who underwent PRB replacement between 2011 and 2017 in the absence of urethral cuff malfunction, atrophy, stricture, or erosion were reviewed. Primary outcomes included changes in pad per day (PPD), Incontinence Symptom Index score, and Incontinence Quality of Life (I-QOL). Secondary outcomes included rates of device erosion and all-cause explant or revision. Differences were compared between patients with and without erosion, explant, or revision. Kaplan Meier device survival analysis was performed. RESULTS: Twenty two patients (67 ± 9 years, body mass index of 30 ± 5 kg/m2) with a median follow up of 22.4 months (IQR 9.3, 47.3) were included. Incontinence etiology included radical prostatectomy in 60% of patients. After PRB exchange, the average number of PPD decreased from 4.0 ± 3.0 to 1.0 ± 1.6 PPD (P = .01), as did Incontinence Symptom Index scores (21.6 ± 8.5 vs 16.3 ± 8.1, P <.001) and Incontinence Quality of Life (15.2 ± 6.8 vs 7.2 ± 3.4, P = .01). Three patients with prior radiation (14%) experienced cuff erosion. The explantation/revision rate was 45%(10/22) at 33.5(IQR 8.9,48) months. Kaplan-Meier analysis demonstrated 68%(15/22) and 41%(9/22) retained their device for 12 and 24 months, respectively. CONCLUSION: PRB exchange can transiently alleviate persistent or recurrent post-AUS SUI in the absence of mechanical failure or urethral pathology. Caution is warranted in patients with prior radiation as this was a risk factor for urethral erosion. Although many patients may require device revision within 2 years, it can be a temporizing solution that avoids urethral manipulation and periprocedural device deactivation.