Four‐year follow‐up on 68 patients with a new post‐operatively adjustable long‐term implant for post‐prostatectomy stress incontinence: ProACT™

Aims: Male stress urinary incontinence (SUI) represents a complication after radical prostatectomy or benign prostatic obstruction surgery. The artificial urinary sphincter is considered the standard treatment but interest on minimally invasive devices, such as adjustable balloons, has recently increased.Aim of this study is to evaluate the efficacy and safety of the ProACT system. Methods:In this multicentric retrospective study, we reported the data from nine centers. Patients with SUI who underwent a ProACT device implantation for postoperative SUI and had a minimum follow-up of 24 months were included. Efficacy was evaluated at the maximum available follow-up and was assessed utilizing a 24-hour pad test. Patients were considered: "Dry" if presenting a urine leak weight lower than 8 g at the 24-hour pad test; "Improved" if presenting a reduction of urine leak higher than 50% (but >8 g/24 hours); "Failure" if presenting a reduction in urine leak lower than 50%. The evaluation included a record of intraoperative and long-term complications.Results: Safety and efficacy results are reported on 240 patients. 29.6% of patients were dry at 24 months, 37.5% were improved and 32.9% of patients were considered failures. The baseline mean pad weight of 367 g was reduced to 123 g at 24 months.Five-year follow-up on 152 patients showed similar efficacy. The complication rate was 22.5%, with the top complication being long-term balloon failure. Conclusions:ProACT implantation represents a safe and efficacious treatment for male postoperative SUI at both medium and long-term follow up. 67.1% of patients were dry or improved at 24 months. The majority of complications are low grade. K E Y W O R D Smale, stress urinary incontinence

Section: Discussionsupporting

confidence: 87%

Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long‐term follow‐up data of a national multicentric retrospective study

Agrò

Gregori

Bianchi

et al. 2019

“…Long‐term failures were primarily attributed to device leakage. Recent studies have shown that the results of reimplantation are comparable to the results after the first implantation . Patients still showed high satisfaction rates even after revisions, demonstrating that patient satisfaction is associated with continence achieved, not with the number of revisions .…”

Section: Discussionmentioning

confidence: 97%

“…29 Higher revision rates for ProACT were shown in papers with longer term follow up. Noordhoff et al 20 19,30 Patients still showed high satisfaction rates even after revisions, demonstrating that patient satisfaction is associated with continence achieved, not with the number of revisions. 31 For those individuals whose incontinence does not improve with ProACT therapy, this minimally invasive treatment can be easily reversed without hindering implantation of a more invasive therapy, such as AUS.…”

Section: Discussionmentioning

confidence: 97%

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

Larson

Jhaveri

Yeung

2019

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.

“…However, the patient baseline characteristics were not always comparable since these studies also included a population of patients with SUI related to transurethral resection of the prostate 16,19‐21,24 . Moreover, in some series, the severity of incontinence at baseline also varies from study to study, particularly the rate of mild incontinence that can range from 3% to 56% 13,14,16,25 . The current study reports 59% of mild SUI.…”

Section: Discussionmentioning

confidence: 79%

Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications

Ricard

Léon

Branchereau

et al. 2022

Objective: The objective of this study was to assess the mid-term efficacy and safety of adjustable continence therapy (ProACT™) for the treatment of male stress urinary incontinence (SUI) after radical prostatectomy (RP).Patients and Methods: Single-center retrospective study including male patients implanted with ProACT™ periurethral balloons for SUI after RP between 2007 and 2017, mainly with flexible cystoscopic guidance. Efficacy was assessed using a composite endpoint with subjective (patient's impression of improvement (PII), using a 0-100 numeral rating scale) and objective outcomes (decrease in daily pad use). Postoperative success was defined as a PII ≥ 80%, associated with the use of 0-1 pad daily. Improvement was defined as a PII ≥ 50% and a decrease ≥50% in the number of daily pads used. Results: Two hundred men with a median age of 68 (64-73) years were included. Seventeen percent (n = 34) had had prior radiotherapy and 15.5% (n = 31) had had prior SUI surgery. The median follow-up was 43 (19-71) months. The severity of SUI was as follows: mild in 119 (59.5%), moderate in 48 (24%), and severe in 33 patients (16.5%). Severe SUI and a history of prior radiotherapy were associated with a lower success rate (p = 0.033 and p < 0.0001). The overall reoperation rate was 34%, with 5.6% (n = 11) requiring a third implantation. Of the patients, 29.4% (n = 58) required an artificial urinary sphincter to treat SUI. At the last follow up, among the overall population, the success rate was 40.1% and the median PII was 18.3%. For patients in whom the balloons were still in place (n = 132), the cumulative success and improvement rate was 78%, with a median PII of 72%. Conclusion:The minimally invasive ProACT™ device provides a clear beneficial continence outcome in patients with SUI after radical prostatectomy. Severe SUI or prior radiotherapy were associated with a lower success rate in our study.