Objective: 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). Materials and methods: 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. Results: 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). Conclusions: ProACT placement below the pelvic floor yielded similar continence but reduced operative time and postoperative visits, at the cost of more early retention.
Axelsen et al. (Mon,) studied this question.