Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications

Area of Science:

• Urology
• Medical Devices
• Post-Prostatectomy Care

Background:

• Male stress urinary incontinence (SUI) is a common complication following radical prostatectomy (RP).
• Existing treatments for post-prostatectomy SUI have varying efficacy and potential complications.
• Adjustable continence therapy (ProACT™) offers a minimally invasive option for managing SUI.

Purpose of the Study:

• To evaluate the mid-term efficacy and safety of the ProACT™ device for treating male SUI after RP.
• To identify factors influencing the success rates of ProACT™ implantation.
• To assess the need for secondary interventions after ProACT™ placement.

Main Methods:

• Retrospective analysis of 200 male patients with SUI post-RP treated with ProACT™ between 2007 and 2017.
• Efficacy assessed via subjective (Patient's Impression of Improvement - PII) and objective (pad usage) measures.
• Success defined as PII ≥80% and ≤1 daily pad; improvement as PII ≥50% and ≥50% pad reduction.

Main Results:

• Median follow-up was 43 months. Overall success rate was 40.1%, with a median PII of 18.3%.
• For patients with ProACT™ still in place (n=132), cumulative success/improvement was 78% (median PII 72%).
• Severe SUI and prior radiotherapy were associated with lower success rates (p=0.033 and p<0.0001, respectively). Reoperation rate was 34%.

Conclusions:

• The ProACT™ device demonstrates mid-term efficacy in improving continence for male SUI patients post-RP.
• Patient factors such as severe SUI and prior radiotherapy negatively impact treatment success.
• While effective for many, a significant portion may require further interventions like artificial urinary sphincters.