What question did this study set out to answer?

The study aims to compare continence and outcomes of ProACT balloon placements above versus below the pelvic floor.

March 13, 2026Scandinavian Journal of Urology0 citationsOpen Access

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

JAJakob Klint AxelsenHerlev Hospital LBLars BoesenHerlev Hospital RBRasmus BisbjergGentofte Hospital

Key Points

The study aims to compare continence and outcomes of ProACT balloon placements above versus below the pelvic floor.
Retrospective cohort study comparing two surgical techniques: above pelvic floor (AP) and below pelvic floor (BP).
Included 38 men in each group, assessing outcomes such as continence, operative time, and complications.
Primary outcome measured was continence defined as ≤1 pad/day or <8 ml leakage over 24 hours.
Median age for BP was 75.5 years and for AP was 70.5 years, with significant age difference (p < 0.0001).
Median surgical time was shorter for BP (15 min) compared to AP (20 min) (p = 0.034).
Early retention occurred in 18.4% of BP versus 0% of AP patients (p = 0.012).
Continence rates were similar: 52.6% for BP and 57.9% for AP (p = 0.64).
Satisfaction rates were 71.1% for BP and 57.9% for AP (p = 0.34).

Abstract

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.

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