Hypothesis / aims of study
Post-prostatectomy incontinence is a complication which significantly impacts patents’ quality of life [1]. After failed conservative treatments, surgery is recommended [2]. While artificial urinary sphincter is the standard surgical treatment for post-prostatectomy incontinence, adjustable continence therapy balloons (ProACT) have emerged as a less invasive alternative over the past two decades (figure 1). Efficacy and complication rates of ProACT are comparable to AUS [3]. ProACT implantation is considered technically challenging and limited to three high-volume Dutch medical centers, yet little is known about the surgical learning curve. This study aims to assess the learning curve of a single surgeon to inform training requirements for ProACT implantation.
Study design, materials and methods
This retrospective single-center study included all ProACT implantations performed by one surgeon, from the start of the learning curve. Surgery success was defined as postoperative use of a maximum of one ‘safety pad’, less than 10 mL urine loss or over 95% subjective improvement of continence. Postoperative urine loss was measured during the first follow-up appointment after the last volume adjustment, since this is the moment of the maximum effect of treatment. Complications were scored using Clavien Dindo classification as a secondary outcome. A multivariable logistic regression assessed the surgical learning curve.
Results
A total of 108 surgeries between 2019 and 2024 were included, of which 15 were performed under supervision of an experienced surgeon. No significant correlation was found between surgeon experience and surgical success (OR 0.89, 95%CI = 0.75–1.07, p = 0.2) (figure 2). Preoperative incontinence (pads/day) was significantly associated with surgery success (OR 0.65, 95%CI = 0.47–0.89, p = 0.009). Surgical success was reached in 61.1% of patients, and a total of 81.5% achieved more than 50% continence improvement. In patients with severe incontinence, this was 47% dry and 78% improved. Complication rate within six months was 21.3%, of which 6 (5.6%) explantations of the ProACT device.
Interpretation of results
The absence of an observed learning curve in this data set, implicates that consistent outcomes can be achieved after a brief supervised training. Overall efficacy and safety of ProACT in this study aligns with prior research. This supports the absence of a significant learning curve, as it includes the first ProACT implantation surgeries performed by a surgeon and does not fall short of the outcomes reported in the literature.
As seen in earlier studies, severe preoperative incontinence is a negative predictor for ProACT success. However, proact treatment can still have a clinically relevant effect for patients with severe urine loss.