Adjustable continence therapy (ProACT^TM): not dead yet—contextualizing an underused surgical technique

Urological surgery for the treatment of male stress urinary incontinence (SUI) still represents a debated topic, because a prosthesis that is suitable for all patients and all situations has not been found. Concerning this issue, we bring to attention the recent systematic review by Fernandez et al. (1) that provides a comprehensive analysis of the safety and effectiveness of the “Adjustable Continence Therapy” (ProACT^TM) for the treatment of SUI. The analysis was conducted on both published papers and post-approval Manufacturer and User Facility Device Experience (MAUDE) database, which makes this analysis particularly relevant.

In the article, the authors reviewed 20 peer-reviewed studies including 1,607 patients, as well as 58 post-approval reports from the MAUDE database. The papers included in the systematic review overall demonstrated that ProACT^TM is associated with 47% risk of adverse effects, which mainly encompass mechanical failure leading to revision (e.g., explantation 24%, with or without replacement 28%), device migration and erosion. Interestingly, the MAUDE database analysis identified slightly different adverse events, namely surgical site infection, urinary retention and an exceptionally catastrophic case of a rectal perforation requiring temporary colostomy. However, most complications were mild to moderate.

In the context of common clinical practice, ProACT^TM is a device that may be used in the treatment of male SUI mainly because of its versatility and minimally invasive approach. The European Association of Urology (EAU) guidelines on non-neurogenic male lower urinary tract symptoms (LUTS) (2) report that ProACT^TM carries a moderate rate of success and may represent a reasonable alternative for treatment of SUI in males, even if it is associated with a non-negligible complication rate [estimated overall revision rate of 22%; level of evidence (LE): 2b].

In fact, the current reference standards for moderate-severe SUI are still represented by the artificial urinary sphincter (AUS), which presents the largest literature support and is the most widely adopted device worldwide. Nonetheless, as is well documented, the rate of adverse events and complications is not negligible. For instance, a retrospective study on 168 patients undergoing AUS (AMS 800^TM) placement revealed 37.5% of cases ended up in AUS failure requiring surgical revision. The main causes were mechanical failure, urethral erosion and infection (3). Another large retrospective multicenter study reported a complication rate of 28% at 32 months follow-up after AUS placement (4). Besides the AUS, male slings are progressively taking hold. Indeed, in some case the role of gold standard of the AUS was questioned in favor of an adjustable male sling, which may provide comparable results in some situations and lower complications (5) with favorable subjective outcomes (6).

On the contrary, there are several studies that provide good evidence about ProACT^TM. For instance, a systematic review and meta-analysis published in 2019 showed positive success rates in patients who underwent ProACT^TM placement for SUI. In this study, a pooled analysis conducted on 1,264 patients showed a “dry rate” of 60% with a surprising percentage of patients who declared themselves either “dry” or “improved” of 82% (7). A 2023 systematic review and meta-analysis on 1,570 patients demonstrated an overall dryness rate of 55.1% with a mean complication rate of 30% and explantation of 26.5% (8).

What is true is that, differently from other devices, ProACT^TM allows a complete postoperative management in an outpatient setting. It includes easy regulation with saline solution and the possibility of easy removal under local anesthesia if complications occur. This makes ProACT^TM particularly suitable for patients who are unfit for surgery. Moreover, ProACT^TM postoperative management does not require any type of skill or training from the patient’s side, which makes it a valuable tool in individuals with reduced cognitive and manual dexterity. These are the points of strength of ProACT^TM that may make this kind of device still appealing in some cases.

What the study by Fernandez et al. makes us aware of is that, besides the well-known risk of mechanical failure and migration, real-life data show a certain risk of infection and even of serious complications such as intestinal perforation. This study stresses the importance of having real-life post-market data that may validate the findings from clinical studies in order to optimize patient counselling and guide the choice among devices.

In this context, a particular remark should be given to the SATURN registry (Surgery for male incontinence with AUSs and slings), whose results were published last year (9). SATURN is a European, prospective, multicenter registry (observational cohort) developed to assess outcomes and statistics of male SUI surgery. In the registry, within the whole cohort of patients, the 896 included in the analysis had 1-year follow-up data, with a mean preoperative 24 h pad-weight of 525 g. The AMS800^TM AUS was the most implanted device (65%), followed by the Advance^TM sling (20%) and the other slings, and ProACT^TM accounting for only 3% of implanted devices. Concerning the ProACT^TM device, the self-reported continence rate at 1 year was 50%, while it ranged between 11% and 76% with the other devices.

By observing these data, it is evident that the ProACT^TM device is adopted at a very low rate, whereas the AUS and male slings remain by far the most frequently implanted devices. Such limited use of ProACT^TM may contribute to a progressive loss of surgical expertise in performing the procedure. Indeed, in our opinion, ProACT^TM outcomes appear to be closely linked to surgical volume and surgeon experience, perhaps more so than with other devices. Consequently, reduced utilization may lead to worsening results in terms of both efficacy and complications. The EAU guidelines also state that ProACT^TM should be used only in expert centers with adequate surgical volume. We strongly agree with this recommendation; nevertheless, we believe that in selected cases (patients with high surgical risk, significant comorbidities, low manual dexterity, or no history of radiotherapy), ProACT may still play a meaningful role, provided that the procedure is performed in a center capable of offering more than one treatment option for male SUI.

To conclude, ProACT^TM is not dead yet because it still may represent a valuable alternative in selected contexts and situations when different and more invasive alternatives are inappropriate.

Acknowledgments

We thank the YAU functional urology working group (Sabrina De Cillis, Department of Oncology, Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy; Cyrille Guillot-Tantay, Hôpital Foch, Service d’urologie et de transplantation rénale, F92150, Suresnes, France; Gokan Çulha, General Directorate of Public Health, Ankara, Türkiye; Luisiana Castillo Carvajal, University Foundation of Health Sciences, San Jose Hospital, Bogotá, Colombia; Rosa Coolen, Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands; Antonio Nacchia, Department of Urology, Sapienza University, Rome, Italy; George Bou Kheir, Department of Urology, Ghent University Hospital, ERN accredited centrum, Ghent, Belgium; Yu Chen-Chen, Department of Urology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung) for the constant contribution to the current and the ongoing projects.

Footnote

Provenance and Peer Review: This article was a standard submission to the journal. The article did not undergo external peer review.

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2025-1-974/coif). The authors have no conflicts of interest to declare.

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