ArticlePublisher preview available

Adjustable continence therapy (proACT) for the treatment of male stress urinary incontinence post-prostatectomy: a systematic review and meta-analysis (2023 update)

Authors:
Thibault Tricard at CHRU de Strasbourg
Thibault Tricard
Qi-Xiang Song
Qi-Xiang Song
Qi-Xiang Song
  • This person is not on ResearchGate, or hasn't claimed this research yet.
Pierre Munier
Pierre Munier
Pierre Munier
  • This person is not on ResearchGate, or hasn't claimed this research yet.
Jia Yi Li
Jia Yi Li
Jia Yi Li
  • This person is not on ResearchGate, or hasn't claimed this research yet.
Show all 8 authorsHide
Read publisher preview
Download citation
To read the full-text of this research, you can request a copy directly from the authors.

Abstract and Figures

Purpose Stress urinary incontinence (SUI) is a key factor for post-prostatectomy (RP) quality of life. Current international guidelines struggle to find the adequate place for each kind of surgeries. The aim of this systematic review and meta-analysis considering updated evidence is to assess the efficacy and safety of proACT in treating male patients with post-RP SUI. Methods A review of the literature was performed by searching the PubMed database. 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 18 studies involving 1570 patients mean age of 68.8 (EC 2.1) were included. The mean follow-up reported was 34.7 months (EC 17.7; median 38.5; range 1–128 months). An average of 60.7% (EC 27) and 40.4% of patients suffered from mild-to-moderate and severe incontinence, respectively. The overall dryness rate was 55.1% (EC 19.3) while respecting the definition of 0–1 pads per day, and the mean dryness rate was 53% (EC 0.2). The mean overall complication rate was 31.2% (EC 18.3%), including an explantation rate of 26.5% (EC 15.3) and a reoperation rate of 22.7% (EC 8.7). The methodological quality of the 18 studies was very heterogeneous. Conclusion Implantation of proACT adjustable balloons is a minimally invasive technique that provides medium outcomes (53%) with a strict definition of dryness (0–1 PPD) and important complication rate (31.2%). Past of irradiation is a negative predictive factor for incontinence.
Figures - available from: World Journal of Urology
This content is subject to copyright. Terms and conditions apply.
A preview of this full-text is provided by Springer Nature.
Learn more
Content available from World Journal of Urology
This content is subject to copyright. Terms and conditions apply.
Vol.:(0123456789)
1 3
World Journal of Urology (2023) 41:1793–1802
https://doi.org/10.1007/s00345-023-04452-6
ORIGINAL ARTICLE
Adjustable continence therapy (proACT) forthetreatment ofmale
stress urinary incontinence post‑prostatectomy: asystematic review
andmeta‑analysis (2023 update)
ThibaultTricard1,2 · Qi‑XiangSong1· PierreMunier3· JiaYiLi1· JingLeng1· ChristianSaussine2· JiaHuaPan1·
WeiXue1
Received: 5 March 2023 / Accepted: 19 May 2023 / Published online: 13 June 2023
© The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2023
Abstract
Purpose Stress urinary incontinence (SUI) is a key factor for post-prostatectomy (RP) quality of life. Current international
guidelines struggle to find the adequate place for each kind of surgeries. The aim of this systematic review and meta-analysis
considering updated evidence is to assess the efficacy and safety of proACT in treating male patients with post-RP SUI.
Methods A review of the literature was performed by searching the PubMed database. 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 18 studies involving 1570 patients mean age of 68.8 (EC 2.1) were included. The mean follow-up reported was
34.7months (EC 17.7; median 38.5; range 1–128months). An average of 60.7% (EC 27) and 40.4% of patients suffered from
mild-to-moderate and severe incontinence, respectively. The overall dryness rate was 55.1% (EC 19.3) while respecting the
definition of 0–1 pads per day, and the mean dryness rate was 53% (EC 0.2). The mean overall complication rate was 31.2%
(EC 18.3%), including an explantation rate of 26.5% (EC 15.3) and a reoperation rate of 22.7% (EC 8.7). The methodological
quality of the 18 studies was very heterogeneous.
Conclusion Implantation of proACT adjustable balloons is a minimally invasive technique that provides medium outcomes
(53%) with a strict definition of dryness (0–1 PPD) and important complication rate (31.2%). Past of irradiation is a nega-
tive predictive factor for incontinence.
Keywords ProACT · Daily pad use· Quality of life· Stress urinary incontinence· Systematic review· Meta-analysis
Introduction
Stress urinary incontinence (SUI) is a major component of
the post-prostatectomy (RP) trifecta. It has been demon-
strated to be one of the key factors for psychological distress,
anxiety and negative social impact leading to a worst quality
of life, with an incidence that varies from 4 to 40% [1–3].
In most patients, functional recovery can be obtained
using pelvic floor muscle exercise and/or physiotherapy
within the first postoperative year [4]. Surgeries might be
needed to achieve a satisfactory quality of life for those with
insufficient symptom control following conservative man-
agement or with moderate-to-severe leakage in the long run
[5].
Current international guidelines struggle to find the ade-
quate place for each kind of surgeries depending on both
patients (incontinence severity, prior radiotherapy, etc.) and
devices characteristics (revision, explantation rates, etc.) [6,
7]. Artificial urinary sphincter is still considered to be the
“gold standard” with a successful rate of about 60% in Chen
etal. meta-analysis [8], while retro-urethralor sub-urethral
slings (R/SUS) and peri-urethral balloons (PUB) are usually
Thibault Tricard and Qi-Xiang Song have contributed equally to this
work.
* Thibault Tricard
thibault.tricard@chru-strasbourg.fr
1 Department ofUrology, Ren Ji Hospital, Shanghai Jiao Tong
University School ofMedicine, Shanghai, China
2 Department ofUrology, Nouvel Hôpital Civil, Hôpitaux
Universitaire de Strasbourg, 1 Place de L’Hôpital,
67000Strasbourg, France
3 Centre d’Urologie UROVAR, Avenue Bizet, 83000Toulon,
France
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
... Adjustable continence therapy is a procedure for men known as ProACT that involves the insertion of two silicone balloons through a perineal approach. This procedure can utilize either endoscopic assistance, realtime fluoroscopy, or transrectal ultrasound guidance [15]. Titanium ports are affixed to each balloon, and they can be accessed through the scrotum, enabling straightforward adjustments to the balloon volume [16,17]. ...
Urinary Incontinence Following Robotic-Assisted Radical Prostatectomy: A Literature Review
Article
Full-text available
  • Jan 2024
Prostate cancer ranks as one of the most prevalent cancers among men in the United States, contributing significantly to cancer-related mortality. Robot-assisted radical prostatectomy (RARP) has become a cornerstone in the management of localized prostate cancer. This literature review delves into the outcomes of RARP, specifically its impact on urinary incontinence (UI) compared to other surgical methods. We also present the importance of patient perception versus medical reports. Recent studies and trials have unveiled that postoperative UI and erectile dysfunction (ED) remain common concerns following prostatectomy. However, studies have shown that RARP has lower occurrences of UI and ED compared to radical retropubic prostatectomy (RRP). While the choice of surgical method may not drastically affect these outcomes, the review emphasizes that urinary incontinence extends beyond physical symptoms. It profoundly impacts patients' psychological well-being, social interactions, and overall quality of life. Differences in symptom recording and interpretation between patients and healthcare professionals can significantly influence the diagnosis and treatment of prostate cancer. Enhanced patient-physician communication and patient-centered care are essential to providing a holistic approach to prostate cancer management. The choice of surgical methods may not significantly impact postoperative urinary incontinence and erectile dysfunction. Continued research and advancements in treatment and patient care are crucial for improving outcomes and the overall well-being of prostate cancer patients.
View
View
View
Systematic review and meta-analysis comparing Adjustable Transobturator Male System (ATOMS) and Adjustable Continence Therapy (ProACT) for male stress incontinence
Article
Full-text available
Background and purpose Urinary incontinence is one of the most serious complications of prostate cancer treatment. The objective of this study was to assess efficacy and safety of Adjustable Transobturator Male System (ATOMS) compared to Adjustable Continence Therapy (proACT) for male stress urinary incotinence according to literature findings. Material and methods A systematic review and meta-analysis on adjustable devices ATOMS and ProACT is presented. Studies on female or neurogenic incontinence were excluded. Differences between ATOMS and proACT in primary objective: dryness status (no-pad or one safety pad/day) after initial device adjustment, and in secondary objectives: improvement, satisfaction, complications and device durability, were estimated using random-effect model. Statistical heterogeneity among studies included in the meta-analysis was assessed using tau2, Higgins´s I2 statistics and Cochran´s Q test. Results Combined data of 41 observational studies with 3059 patients showed higher dryness (68 vs. 55%; p = .01) and improvement (91 vs. 80%; p = .007) rate for ATOMS than ProACT. Mean pad-count (-4 vs. -2.5 pads/day; p = .005) and pad-test decrease (-425.7 vs. -211.4 cc; p < .0001) were also significantly lower. Satisfaction was higher for ATOMS (87 vs. 56%; p = .002) and explant rate was higher for proACT (5 vs. 24%; p < .0001). Complication rate for ProACT was also higher, but not statistically significant (17 vs. 26%; p = .07). Mean follow-up was 25.7 months, lower for ATOMS than ProACT (20.8 vs. 30.6 months; p = .02). The rate of working devices favoured ATOMS at 1-year (92 vs. 76; p < .0001), 2-years (85 vs. 61%; p = .0008) and 3-years (81 vs. 58%; p = .0001). Significant heterogeneity was evidenced, due to variable incontinence severity baseline, difficulties for a common reporting of complications, different number of adjustments and time of follow-up and absence of randomized studies. Conclusions Despite the limitations that studies available are exclusively descriptive and the follow-up is limited, literature findings confirm ATOMS is more efficacious, with higher patient satisfaction and better durability than ProACT to treat male stress incontinence.
View
Long-term results of ProACT primary and repeat implantation for treatment of stress urinary incontinence in men
Article
Full-text available
  • Jun 2019
  • WORLD J UROL
Introduction Urinary incontinence in men after radical prostatectomy affects strongly quality of life. If conservative treatment fails, surgical treatment consists of implantable devices. If the requirement of manual dexterity in the artificial sphincter is to be avoided, the ProACT system offers a readjustable system, which shows good continence, but also high revision rates. Aim of our single-centre, single-surgeon study was to evaluate the success and revision rates of ProACT over long-term follow-up and if repeat ProACT implantation after failure would be a reasonable strategy. Materials and methods In May 2017, follow-up of all patients who underwent ProACT implantation between 2003 and 2013 was obtained. Parameters were numbers of pads used, filling volume of balloons, and patient-reported satisfaction. Furthermore, revisions were noted. Results Between 2003 and 2013, 134 patients were implanted a ProACT system. Median age was 71 years; median follow-up was 118 months. 112 implantations were successful (82.6%) and the number of pads used decreased significantly (p < 0.005). 63 patients were revised and 49 were successful (77.8%). No differences in success rate, pads used, or filling volume were seen (all p > 0.8). In a second revision, again, no differences in success rate or pads used were noted (all p > 0.7). Patients’ personal satisfaction was high despite the high revision rate. Conclusion In the hands of an experienced surgeon, ProACT is a safe and effective therapy for post-prostatectomy incontinence especially if mayor surgery is to be avoided. Revision rates are high, but the results of ProACT reimplantation are comparable to the results after the first implantation.
View
Outcome and complications of adjustable continence therapy (ProACT™) after radical prostatectomy: 10 years’ experience in 143 patients
Article
Full-text available
  • Dec 2017
Aims: To evaluate our outcomes of the adjustable continence balloons ProACT™ for the treatment of male stress urinary incontinence after radical prostatectomy. Methods: Between May 2007-August 2016 the ProACT™ was implanted in 143 patients without a history of radiotherapy. Endpoints were patient-reported changes in pad counts and complications. Treatment was considered successful if no pad or just one "security" pad per day sufficed, and improved if daily pad use was reduced by ≥50%. Results: Incontinence before implantation was mild in 36 (25%), moderate in 57 (40%), and severe in 50 (35%) patients. Complications within 30 days were classified by the Clavien-Dindo classification; eight (5.6%) grade I, three (2.1%) grade II, three (2.1%) grade IIIb, and 129 (90.2%) patients had no complication. Revision was done in 43 (30%) patients. The IPSS quality of life item improved significantly from 5.0 (IQR 4.0-5.0) preoperative to 2.0 (IQR 1.0-4.0) and 1.0 (IQR 0.0-3.0) 6 and 12 months after implantation, respectively. After a median follow up of 56 months (range 28 to 79, n = 112), 72 (64%) patients were improved, including 51 (45%) patients were successful. Daily pad use decreased from 3.0 to 1.0 (67% reduction). The median outcome on the Patient Global Impression of Improvement scale was "much better," and 97 (87%) patients perceived improvement. Conclusions: The minimally invasive ProACT™ device showed a clear beneficial continence outcome in patients with stress urinary incontinence after radical prostatectomy. The majority of the patients were satisfied and perceived improvement ≥50% on daily pad use on the long term.
View
Targeting Moderate and Severe Male Stress Urinary Incontinence With Adjustable Male Slings and the Perineal Artificial Urinary Sphincter: Focus on Perioperative Complications and Device Explantations
Article
Full-text available
  • Jun 2017
  • Int Neurourol J
Purpose To analyze perioperative complications and postoperative explantation rates for selected readjustable male sling systems and the perineal single-cuff artificial urinary sphincter (AUS) in a large, contemporary, multi-institutional patient cohort. Methods Two hundred eighty-two male patients who underwent implantation between 2010 and 2012 in 13 participating institutions were included in the study (n=127 adjustable male sling [n=95 Argus classic, n=32 Argus T], n=155 AUS). Perioperative characteristics and postoperative complications were analyzed. The explantation rates of the respective devices were assessed using the Fisher exact test and the Mann-Whitney U-test. A Kaplan-Meier curve was generated. Potential features associated with device explantation were analyzed using a multiple logistic regression model (P<0.05). Results We found significantly increased intraoperative complication rates after adjustable male sling implantation (15.9% [adjustable male sling] vs. 4.2% [AUS], P=0.003). The most frequent intraoperative complication was bladder perforation (n=17). Postoperative infection rates did not vary significantly between the respective devices (P=0.378). Device explantation rates were significantly higher after AUS implantation (9.7% [adjustable male sling] vs. 21.5% [AUS], P=0.030). In multivariate analysis, postoperative infection was a strong independent predictor of decreased device survival (odds ratio, 6.556; P=0.001). Conclusions Complication profiles vary between adjustable male slings and AUS. Explantation rates are lower after adjustable male sling implantation. Any kind of postoperative infections are independent predictors of decreased device survival. There is no significant effect of the experience of the implanting institution on device survival.
View
Adjustable continence balloons in postprostatectomy incontinence: Outcomes and complications
Article
  • Jun 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.
View
What if artificial urinary sphincter is not possible? Feasibility and effectiveness of ProACT for patients with persistent stress urinary incontinence after radical prostatectomy treated by sling
Article
  • Apr 2020
Background Stress urinary incontinence (SUI) is a major component of the post radical prostatectomy (RP) trifecta. Surgical treatments are sub‐urethral slings, artificial urinary sphincter (AUS) and adjustable peri‐urethral balloons (PUB) ProACT. All options are imperfect at best and persistent SUI is challenging when AUS is not manageable. Aims This study analyzed the cumulate experience of our 2 centers with offering PUB implantation for SUI post RP in patients with insufficient improvement from slings. Materials & Methods This retrospective study reviewed all patients implanted with second line ProACT. The primary endpoint was continence, defined as 0 pads per day (PPD). The secondary endpoints were 50% decrease in PPD and increases in the Incontinence Quality of Life score (IQOL). Refilling and complications were reported. Results Between 2007 and 2016, 26 patients were implanted. Five patients have had adjuvant radiotherapy (18%). The mean follow‐up was 36 months (±20; min 14‐max 128). All patient presented with persistent SUI, using 2.3 PPD (±1; min 1–max 6), and only one sling was removed due to infection. After ProACT with an average 3 mL refilling (±1.2 min 2–max 6), 18 patients (66.7%) were continent. Eight of the remaining patients (29.6%) were improved; their number of PPD decreased from 2.6 to 1. The average IQOL score of those 8 patients increased by 20 points, from 53.4 up to 74.2 (P = .005). Overall 26 patients (96.3%) were improved. The remaining patient was not implanted because of an intraoperative urethral injury and is considered a failed case (3.7%). He had instead an AUS implantation. Three patients (14.8%) needed PUB replacement. Conclusion The limited population of patients from both our centers who presented with persistent SUI after RP, despite sling placement, improved with PUB ProACT implantations without significant complications.
View
Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and meta‐analysis
Article
  • Aug 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.
View
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
Article
  • Jul 2019
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.
View
Four‐year follow‐up on 68 patients with a new post‐operatively adjustable long‐term implant for post‐prostatectomy stress incontinence: ProACT™
Article
  • Oct 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.
View