Outcome and complications of adjustable continence therapy (ProACT™) after radical prostatectomy: 10 years’ experience in 143 patients

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.

Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

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

Larson

Jhaveri

Yeung

2019

“…The dry rate (45%) at last outpatient visit and reintervention rate (24%) found in the present study fall within the respective ranges. Additionally, the previously published results of adjustable continence balloons in patients with SUI postradical prostatectomy implanted by one of the surgeons of this study were added to Table to compare with the present study. Overall, results in the literature are slightly similar but important to note, besides the etiology, the size, and duration of follow‐up of study populations differ.…”

Section: Discussionmentioning

confidence: 99%

“…The latter device consists of two periurethrally placed balloons (ProACT TM ) whose volumes can be adjusted to achieve the optimal balance between voiding pressure and continence . Reported long‐term dry rates (no pad or one security pad) range from 45% to 66% with a follow up of 56 to 58 months . The majority or all patients included in these studies were treated for SUI after radical prostatectomy.…”

Section: Introductionmentioning

confidence: 99%

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Outcome and complications of adjustable continence therapy (ProACT^TM) in the treatment of urinary incontinence after transurethral resection of the prostate: A multicenter study

Noordhoff

Finazzi‐Agrò

Scheepe

et al. 2019

Self Cite

AimTo evaluate the outcome of adjustable continence balloons in the treatment of stress urinary incontinence (SUI) after transurethral resection of the prostate (TURP).MethodsIn two tertiary centers, adjustable continence balloons were implanted in 29 patients with post‐TURP SUI between 2007 and 2018. Endpoints of this retrospective multicenter study were patient‐reported changes in pad count and complications. Dry was defined as no pad or one security pad.ResultsPreoperative urinary incontinence was mild in 7 (24%), moderate in 12 (41%), and severe in 10 (35%) patients. The median follow‐up duration was 21 (interquartile range [IQR], 11‐43) months. Within 30 days postoperatively, a Clavien‐Dindo grade less than or equal to II complication occurred in 24% of the patients. Reintervention rate was 24%. Six and 12 months after implantation, the International Prostate Symptom Score (IPSS) quality‐of‐life item improved significantly from 5 (IQR, 5‐6) preoperatively to 3 (IQR, 1‐4.5) and 1 (IQR, 0‐3), respectively. At last visit (median 21 months after implantation), the outcome on continence had improved in 76% of the patients, including, 45% dry patients. After a median follow‐up of 28 months (IQR, 13‐63; N = 23), all but one patient reported improvement on the Patient Global Impression of Improvement (PGI‐I) scale. In detail, 10 patients reported “very much better” condition compared with before the implantation, 10 patients “much better,” two patients “a little better,” and one patient “no change.” Daily pad use decreased from three (IQR, 2‐5) to one (IQR, 0‐2) pads/day (P < 0.001).ConclusionsThis is hitherto, the first study reporting results of adjustable continence balloons in the treatment of post‐TURP SUI. The therapy was found to be safe and efficient. The majority of our study population reported improvement on their condition and greater than or equal to 50% reduction in daily pad use.

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

Nash

Aboseif

Gilling

et al. 2018

Aims: This paper presents 4-year follow-up results for patients enrolled in a pivotal study conducted to support an FDA premarket approval application (PMAA). The study evaluated the safety and efficacy of the ProACT Adjustable Continence Therapy for the treatment of post-prostatectomy stress urinary incontinence (SUI). Methods: The clinical study involved 11 clinical sites and enrolled 160 subjects, all male. A total of 124 subjects met study criteria and 123 were implanted with ProACT. Baseline and outcomes for 68 patients who completed 4-year follow-up visits are reported. Endpoints included 24-h pad weight, Incontinence Quality of Life Questionnaire (I-QOL), UCLA Prostate Cancer Index-Urinary Function (PCI-UF), residual volume, and incidence and severity of device or procedure-related adverse events. Results: Statistically significant improvements during follow-up were observed in 24-h pad weight, for which the mean pre-implant urine loss was 293 g, which was reduced at 4 years to 73 g (P < 0.001). Reductions in pad weight were observed across all levels of pre-implant SUI severity. Significant improvements were also seen in quality of life as measured by the I-QOL (P < 0.001) as well as measures of urinary function and pad use. One procedure-related SAE (retention) was reported among the 68 subjects; the SAE was resolved without clinical meaningful sequalae. Conclusions: These results confirm the long-term safety and efficacy of this newly FDA-approved therapy, showing significant improvements in both objective and subjective measures of SUI in mild, moderate, and severely incontinent male patients.The implant procedure is minimally invasive, and complications are generally mild and easily resolvable.