Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta‐analysis

Abstract

Aims First, to evaluate the efficacy of adjustable balloon devices or adjustable continence therapy (ProACT) in the treatment for male stress urinary incontinence (SUI). Second, to investigate the safety profile and rates of adverse events associated with the implantation of adjustable balloon devices. Method A review of the literature was performed by searching the PubMed database with the most applicable search terms. We narrowed included studies with adult male patients with SUI; outcomes included pads or pad weight per day and quality of life (QOL) questionnaires, as well as safety outcomes. Results In total, 19 studies were included with a total of 1264 patients and 4517 patient‐years of follow‐up data (mean follow‐up time 3.6 years). ProACT implantation resulted in an incontinence QOL improvement of 30.8 points from baseline. At baseline, patients on average were using 4.0 pads per day (PPD) (95% confidence interval [CI]: 2.6‐5.4), which was reduced to an average of 1.1 PPD (95% CI: 0.5‐1.7) after ProACT implantation. The number of patients that were considered “dry” was 60.2% (95% CI: 54.2%‐65.9%) and the number of patients who were found to be either “dry” or improved greater than 50% was 81.9% (95% CI: 74%‐87.8%). Conclusions Implantation of adjustable balloon devices is efficacious and safe for the treatment of male SUI. Given the minimal invasiveness of the therapy, adjustable balloon devices may be a serious option as a first‐line treatment in nonirradiated patients with SUI who are not ideal candidates for the artificial urinary sphincter.

Systematic review and meta-analysis comparing Adjustable Transobturator Male System (ATOMS) and Adjustable Continence Therapy (ProACT) for male stress incontinence

“…The patient carries out urination without manipulation and the risk of mechanical failure is minimal, due to simplicity. Recent systematic reviews and meta-analysis confirm both ATOMS and ProACT are efficacious and safe alternatives to treat male stress incontinence of different degree but provide no comparison between them [53,54]. Interestingly, individual data reported for each device in those meta-analysis is very consistent with data here presented.…”

“…ProACT has been implanted for two decades in Europe and more recently in the United States, often in outpatient basis under X-ray or transrectal ultrasound guidance. Based on this minimally invasiveness it has been recommended as first-line treatment in non-irradiated patients with mild-to-moderate incontinence [6,54,56], although revision and explantation rates are high [18,27,29,30] because a correct positioning of the balloons is mandatory to achieve good results [21]. Based on our findings, ProACT does not appear to be an ideal device for durable continence or patient satisfaction.…”

A narrative review on surgical treatment options for male stress urinary incontinence

“…Lastly, the ProACT (Uromedica Inc., Plymouth, MN, USA) device differs from our previous implants in that it provides a non-circumferential compression on the urethra. This system is placed transperineally under fluoroscopic guidance, endoscopic assistance, or ultrasound and consists of two balloons placed on either side of the bladder neck and adjustment ports within the scrotum (47). The ports can be accessed percutaneously in the outpatient setting to further inflate or deflate the balloons based on the patient's response to treatment.…”

Prosthetics in urology: Current status and future directions

“…In a recent meta-analysis, 81.9% of patients showed improvement in continence, and pad usage reduced from 4 to 1.1 pads/day. [ 41 ]…”