Introduction of a modified surgical approach for ProACT balloon placement: a retrospective cohort study

To compare adjustable continence balloons (ProACT) implanted above the pelvic floor with or without subsequent placement of a third balloon (AP) with a modified technique placing balloons below the pelvic floor (BP).

We retrospectively compared 38 men who underwent the BP procedure and 38 men who received the AP technique. Primary outcome was continence (≤1 pad/day or <8 ml/24 h leakage). Secondary outcomes included operative time, complications, number of balloon filling visits, and satisfaction.

Median age was 75.5 years (BP) and 70.5 years (AP) (p < 0.0001). Groups were comparable in preoperative incontinence severity. Median surgical time was 15 min (BP) versus 20 min (AP) (p = 0.034). Early retention occurred in 18.4% (BP) versus 0% (AP) (p = 0.012). A third balloon was inserted in 39.4% of AP patients, and median number of fillings (6 vs. 10, p = 0.0006) was lower in BP group. Late complications consisting of migration, erosion, and balloon puncture were similar (23.7% BP vs. 36.8% AP, p = 0.32). Continence was achieved in 52.6% (BP) and 57.9% (AP) (p = 0.64), and satisfaction was reported by 71.1% (BP) and 57.9% (AP) (p = 0.34). On multivariate analyses, surgical method did not predict outcomes, and Cox regression shoved that BP was associated with a non-significant hazard of revision (HR: 1.60; 95% confidence interval [CI]: 0.53-4.85; p = 0.40).

ProACT placement below the pelvic floor yielded similar continence but reduced operative time and postoperative visits, at the cost of more early retention.