Stress urinary incontinence affects up to 70% of men following radical prostatectomy. The gold standard implantable device for post-prostatectomy stress urinary incontinence (ppSUI) remains the artificial urinary sphincter (AUS). However, the AUS carries the risk of device malfunction and erosion and requires adequate manual dexterity for proper operation. This requirement presents a barrier for men of advanced age hoping to achieve urinary continence. The ProACT adjustable continence system is a balloon implant that allows for a titratable increase in bladder outlet resistance for men with ppSUI. The device employs two inflatable balloons placed using fluoroscopic guidance just above the genitourinary diaphragm via subcentimeter, perineal incisions. We analyze the safety and efficacy of this device in a cohort of men at our institution.

After obtaining ethical Institutional Review Board approval (IRB20220159), a retrospective review of patients undergoing ProACT balloon placement for ppSUI between September 2019 and April 2022 was performed. Twenty-seven patients who underwent ProACT balloon device placement for mild to severe ppSUI were identified. Two patients were excluded from analysis secondary to device explant. Preoperative and postoperative Male Stress Incontinence Grading Scores (MSIGS) were used as our objective metric for improvement of ppSUI. MSIGS was determined per standing four cough test with a minimum 60 minute delay following the last void. MSIGS 0 indicates leakage per history without exam findings, 1 demonstrates delayed drops, 2, early drops, 3, a delayed stream and 4, an early stream per urethra.

Twenty-seven patients underwent successful placement of the ProACT device. Median follow-up was 13 months. Preoperative mean MSIGS score was 2.88 with postoperative mean MSIGS score of 1.12 (p<0.001). Mean final fill volume was 4.1mL in each balloon. Two patients experienced balloon erosion requiring device removal and were not included in the analysis. Including the two erosions, nine complications were noted, three of which required revision for device malfunction, most commonly due to balloon or port rupture. Two patients experienced postoperative pain and two experienced postoperative urinary retention. Six of the 27 patients had undergone radiation therapy as either primary or salvage therapy for prostate cancer. No complication required intervention more invasive than subcentimeter perineal incisions to remove the device. On average, the addition of 1mL to each balloon improved continence 0.5 points on the MSIGS scale.

The ProACT adjustable balloon system is an effective, minimally invasive treatment option for ppSUI that results in a statistically significant improvement in Male Stress Incontinence Grading Scores. In the event of a complication, the device is easily removable with minimal resultant morbidity.

Successful and safe outcomes with the ProACT device, without patient activation, suggest it may be a good alternative to AUS for independent patients with low dexterity.

Morey A, Singla N, Chung P, Klein A, Tausch T, Siegel J, Tachibana I, Scott J, Carmel M. Male Stress Incontinence Grading Scale (MSIGS) for Evaluation of Men with Post-Prostatectomy Incontinence: A Pilot Study. Video J Prosthet Urol. 2016 Feb 24;2:64. PMID: 32259169; PMCID: PMC7133709.
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