Adjustable continence therapy for men (ProACTTM): systematic review and compendium of adverse events
Review Article

Adjustable continence therapy for men (ProACTTM): systematic review and compendium of adverse events

Adrian M. Fernandez1 ORCID logo, Hiren V. Patel1, Kevin D. Li1, Ashwin S. Balakrishnan1, John Buie2, Umar Ghaffar1, Nizar Hakam1, Benjamin N. Breyer1,3

1Department of Urology, University of California San Francisco, San Francisco, CA, USA; 2Department of Urology, Texas Tech University Health Sciences Center, Lubbock, TX, USA; 3Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA

Contributions: (I) Conception and design: AM Fernandez, HV Patel, BN Breyer; (II) Administrative support: AM Fernandez, N Hakam; (III) Provision of study materials or patients: AM Fernandez, N Hakam, U Ghaffar; (IV) Collection and assembly of data: AM Fernandez, KD Li, AS Balakrishnan, J Buie, N Hakam, U Ghaffar; (V) Data analysis and interpretation: All authors; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Benjamin N. Breyer, MD, MAS. Department of Urology, University of California San Francisco, Box 0738, 400 Parnassus Ave., A632, San Francisco, CA 94143, USA; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA. Email: Benjamin.Breyer@ucsf.edu.

Background: Adjustable continence therapy for men (ProACTTM) is an inflatable para-urethral balloon approved for consumer use in the United States by the Food and Drug Administration in 2015. Post-approval adverse events (AEs) have been catalogued in Manufacturer and User Facility Device Experience (MAUDE). To characterize the complication profile of the device, we systematically reviewed all publications and MAUDE narratives outlining AEs related to ProACTTM.

Methods: Thirty-one peer-reviewed publications studying ProACTTM implantation in humans were identified by search of PubMed and Google Scholar using combination of keywords “ProACT”, “balloon”, and “continence”. Eleven studies were excluded. The MAUDE database was searched for reports of AEs related to the placement of ProACTTM and narratives of AEs were characterized.

Results: Of 1,607 patients treated in published studies, 752 AEs occurred. The most common were mechanical failure (n=224, 30%), device migration/malposition (n=155, 21%), and device erosion (n=120, 16%). Devices were explanted in 24% of patients and revised or reimplanted in 28% of cases. In the MAUDE database, the AEs identified were similar, with most common complications including device erosion (n=32, 49%), surgical site infection (n=15, 19%), and urinary retention (n=9, 11%).

Conclusions: Use of the ProACTTM device is associated with a high rate of AEs. Limitations include the lack of clinical details in the MAUDE database.

Keywords: Stress urinary incontinence (SUI); male incontinence; adjustable continence therapy (ProACT); Manufacturer and User Facility Device Experience database (MAUDE database)

Submitted Oct 18, 2024. Accepted for publication Mar 04, 2025. Published online May 27, 2025.

doi: 10.21037/tau-24-587

Highlight box

Key findings

• The most common adverse events (AEs) associated with adjustable continence therapy for men (ProACTTM) are mechanical failure, device migration/malposition, and device erosion. Devices were explanted in 24% of patients and revised or reimplanted in 28% of cases.

What is known and what is new?

• Individual case series have summarized AEs related to ProACTTM.

• This systematic review summarizes the published literature on the device’s safety profile. We also summarize “real-world” AEs through analysis of the Manufacturer and User Facility Device Experience database.

What is the implication, and what should change now?

• Use of the ProACTTM device is associated with a high rate of AEs. This data should be used to educate risk/benefits discussions with patients considering utilizing the device.

Introduction

Stress urinary incontinence (SUI) is a growing problem facing our aging population (1). SUI results from surgery for prostate cancer or benign prostatic hypertrophy, the most common non-cutaneous cancer and benign urologic disease in men, respectively (2). SUI rates increase as men grow older, with prevalence in men aged 65+ years ranging from 10–30% (1).

Treatment options are limited for severe male SUI. Though male urethral slings and artificial urinary sphincters (AUS) are effective treatments for many men with incontinence, these devices require open perineal surgery and are not adjustable once they are surgically placed. The adjustable continence therapy for men (ProACTTM) has been developed as an alternative treatment for male SUI and is also an effective treatment option per American Urologic Association (AUA) guidelines (3). This device is an inflatable para-urethral balloon approved for consumer use in the United States by the Food and Drug Administration (FDA) in 2015 (Figure 1). The device compresses the urethra passively and offers a unique advantage compared to other SUI interventions by allowing inflation adjustment to optimize continence for each patient (4-6).

Figure 1 Fluoroscopic image of correct placement of ProACT (photo credit Dr. Kirk Redger, Dr. Redger has granted permission for the publication of this photo). ProACT, adjustable continence therapy.

Pre-approval safety reports highlight side effects of ProACT device including urinary retention, pain, ongoing incontinence, device migration, and bladder perforation (7-9). After FDA approval, adverse events (AEs) can be submitted to the Manufacturer and User Facility Device Experience (MAUDE) database, through which voluntary and mandated reporters can submit anonymous reports of real-world device complications. Reviews of MAUDE reports regarding other urologic technologies have uncovered unforeseen, severe complications related to post-approval device use (10,11). The current study systematically reviews all published safety data related to ProACT in both literature and the MAUDE database. The work will further inform implanters and patients of the risks of device placement. We present this article in accordance with the PRISMA reporting checklist (available at https://tau.amegroups.com/article/view/10.21037/tau-24-587/rc).

Methods

Review of published safety data

Bibliometric search engines PubMed and Google Scholar were used to identify peer-reviewed articles related to ProACT implantation in humans using the combination of keywords “ProACT”, “balloon”, and “continence” on October 15, 2023. Search results dated from first-in-human studies published in 2005 through December 2023, the time of the search. Potential studies were screened by one author (A.M.F.). Conference abstracts, articles not in English, and studies with overlapping populations were excluded. If two publications included overlapping populations, the article with fewer patients was excluded.

We reviewed selected studies in detail by one author (A.M.F.) for safety data related to ProACT implantation. We extracted total number of patients treated, length of follow-up, balloons placed, complications sustained, and post-implantation procedures related to the ProACT placement. AEs documented included surgical site infection, device erosion into nearby structures (urethra, bladder, rectum, skin), ProACT migration away from its site of placement, pain, urinary retention, hematuria, and perforation of adjacent organs (bladder, urethra, colon) on placement of the device. Post-implantation procedures documented included device explantation, ProACT reimplantation, bladder catheterization, cystoscopy, suprapubic tube placement, and any other procedures mentioned. Severity of AEs were categorized using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (12).

MAUDE database review

MAUDE reports were identified on October 14, 2023 by searching the MAUDE database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) for AEs that related to the placement of ProACT. Injuries related to the Proact Transfer Sling, a patient mobility device, were excluded. ProACTTM MAUDE narratives spanned from November 2018 through December 2023. Narratives were reviewed individually by two authors (A.M.F. and either K.D.L., U.G., or J.B.) to reduce risk of bias. All AEs and post-implantation procedures described were catalogued in a similar fashion to the AEs reviewed in the published literature.

Statistical analysis

Descriptive statistics were arranged and computed using Microsoft Excel, version 16.75 to evaluate safety data, including results from published literature and the MAUDE database.

The study protocol is available upon request, and no amendments were made after initiation of the protocol.

Results

Published AEs

Thirty-one peer-reviewed publications were identified using our search criteria. Eleven studies were excluded: seven because they reported on overlapping populations, three because full text versions could not be found in English, and one because it studied simultaneous implant of ProACT with another device. Ultimately 20 peer-reviewed publications were analyzed (Figure 2, Table S1) (7-9,13-29).

Figure 2 Flow diagram of peer reviewed publications included for safety analysis.

One thousand six hundred and seven patients were treated with ProACTTM in published studies. Seven hundred and fifty-two AEs were identified, yielding an AE rate of 47% of patients. The most common AEs in published studies were mechanical failure (n=224, 30%), device migration/malposition (n=155, 21%), device erosion (n=120, 16%), surgical site infection (n=62, 8%), urethral perforation (n=48, 6%), bladder perforation (n=46, 6%), urinary retention (n=35, 5%), and scrotal hematoma (n=20, 3%). Eight hundred and twenty-five post-implantation procedures were described, consisting of device revision or reimplantation (n=442, 54%) and device explantation (n=383, 46%) (Tables 1,2). See Table S1 for AE rates published in each study.

Table 1

AEs identified in the published literature and post-approval, “real world” setting (complications associated with ProACT device placement)

AE N [%]
Published literature
   Total 752 [100]
   Mechanical defect/failure 224 [30]
   Device malposition/migration 155 [21]
   Device erosion (any) 120 [16]
   Surgical site/device infection 62 [8]
   Urethral perforation 48 [6]
   Bladder perforation 46 [6]
   Urinary retention 35 [5]
   Other/unspecified 29 [4]
   Hematoma/bleeding 20 [3]
   Pain 12 [2]
MAUDE database
   Total 80 [100]
   Surgical site/device infection 15 [19]
   Urinary retention 9 [11]
   Erosion to bladder 9 [11]
   Erosion to skin 9 [11]
   Erosion to urethra 8 [10]
   Other† 7 [9]
   Unspecified erosion 6 [10]
   Bladder perforation 4 [7]
   Unspecified perforation 4 [7]
   Device malposition/migration 4 [7]
   Hematoma/bleeding 3 [5]
   Rectal erosion 2 [3]

†, “Other” AEs identified in the MAUDE database included hematuria (n=2, 3%), pain (n=2, 3%), urinary tract infection (n=1, 1%), urinary urgency (n=1, 1%), and unspecified issue with the device (n=1, 1%). AE, adverse event; MAUDE, Manufacturer and User Facility Device Experience; ProACT, adjustable continence therapy.

Table 2

Adverse events identified in the published literature and post-approval, “real world” setting (procedures required after ProACT device placement)

Procedure N [%]
Published literature
   Total 825 [100]
   Device reimplantation or revision 442 [54]
   Device explantation 383 [46]
MAUDE database
   Total 65 [100]
   Device explantation 37 [57]
   Foley catheterization 10 [15]
   Device reimplantation 9 [14]
   Cystoscopy 5 [8]
   Suprapubic tube placement 2 [3]
   Bowel diversion 1 [2]
   Unspecified 1 [2]

MAUDE, Manufacturer and User Facility Device Experience; ProACT, adjustable continence therapy.

Fourteen AEs could not be graded according to the CTCAE system due to lack of clinical details. Of the remaining 738 AEs identified, 1.2% were CTCAE grade 1 (n=9), 61% grade 2 (n=450), and 37% grade 3 (n=276). There were 1 and 2 events that were grade 4 and 5, respectively, which were deemed unrelated to ProACT placement (Figure 3).

Figure 3 CTCAE adverse event grading number (%) based on published literature (A) and MAUDE complication narratives (B). CTCAE, Common Terminology Criteria for Adverse Events; MAUDE, Manufacturer and User Facility Device Experience.

Post-approval AEs

Fifty-eight MAUDE reports were identified that related to the placement of ProACT. In the MAUDE database, 80 AEs were identified. The most common AEs identified were surgical site or device infection (n=15, 19%); urinary retention (n=9, 11%); device erosion to bladder (n=9, 11%); skin (n=9, 11%); urethra (n=8, 10%); or other location (n=6, 10%); bladder perforation on device placement (n=4, 7%); device malposition/migration (n=4, 7%); hematoma formation (n=3, 5%); rectal erosion (n=2, 3%); and unspecified/other AEs (n=7, 9%). “Perforation” differs from “erosion” in that perforation occurs at device placement, while erosion occurs afterward.

Sixty-five post-implantation procedures were described including device explantation (n=37, 57%), bladder catheterization (n=10, 15%), ProACTTM reimplantation (n=9, 14%), cystoscopy (n=5, 8%), suprapubic tube placement (n=2, 3%), and one unspecified procedure (n=1, 2%). MAUDE database complications also include one event of rectal perforation on device placement necessitating colostomy.

Of the AEs described in the MAUDE database, 12% were CTCAE grade 1, 74% grade 2, 12% grade 3, 2% grade 4, and 0% grade 5 (Figure 3).

Discussion

The current work summarizes the complications associated with placement of ProACT. We include injuries noted in both the literature and in the post-approval, “real world” setting. Complications are common and are predominantly categorized as CTCAE grade 1 or 2.

Across all ProACT implants reported in academic literature, the most common AEs in were mechanical failure (14% of implants), device malposition/migration (10%), and device erosion (7%). Device infection rate was 4% across all cases, and the bladder and urethra were each perforated in 3% of implants. These rates should inform risk/benefit discussions as patients and providers consider utilizing this incontinence device. Devices were explanted in 24% of patients and revised or reimplanted in 28% of cases. AUA guidelines indicate “mean all-cause (i.e., erosion, infection, balloon migration or balloon failure) explantation rate of 27% (range: 7% to 55%)” (3,4).

While the MAUDE database does not provide complication rates, reviewing these narratives provides important insights into the safety landscape for devices in the “real world”. MAUDE has historically been studied to highlight unforeseen safety concerns in FDA-approved devices (11). The AE reports from the MAUDE database are overall consistent with the pre-approval safety profile from published literature. Review of the database revealed one AE (report number 3003477176-2018-00026), in which both ProACT balloons were extruded from the patient’s rectum shortly after device placement. The rectum was perforated during percutaneous device placement, and the patient ultimately required a diverting colostomy. Though this may represent an isolated event, patients and providers should be aware of the possibility of this rare but real complication.

Review of the published literature provides insights into optimizing the safety of ProACTTM device placement. Though the transrectal ultrasound (TRUS) guided placement is not an approved delivery strategy per the manufacturer’s information for users, ProACT has been placed under fluoroscopic or TRUS guidance (30). In a case series by Finazzi Agrò et al., 16 bladder or urethral perforations all occurred with placement under fluoroscopic guidance (14). The MAUDE case of rectal perforation did not disclose whether this occurred after fluoroscopic or TRUS guidance, but the transrectal approach may be favorable to prevent such catastrophic injuries in the future. Additionally, in the case series of Crivellaro et al., all patients sustaining an AE had been previously undergone pelvic radiation therapy (17). Future studies should carefully consider the comparative safety of ProACT placement in irradiated vs. non-radiated patients and when using the fluoroscopic vs. TRUS-guided approach.

Evaluation of the safety profile of ProACT should consider the safety of other implantable urologic devices for incontinence. In the case of AUS, a large retrospective, multicenter study recently indicated a total complication rate of 28% at 32 months follow-up, with infection and erosion occurring in 4.2% and 6.7% of implants, respectively (31). Systematic review of complications from male urethral sling placement demonstrate overall complication rates of 2–83%, infection rates of 0–19.6% urinary retention rates of 0–44%, and erosion in 0–6% of cases (32). With ProACTTM, rates of serious AEs such as infection (4%), device failure (14%), and erosion (7%) were similar to AUS and urethral sling placement, though the rate of total AEs were higher with ProACT (47%) than AUS.

Limitations of the current study include those intrinsic to the MAUDE database. As stated by the MAUDE website, “MAUDE data is based on voluntary reporting, meaning it may not capture all AEs. The databank does not establish a cause-and-effect relationship between the device and the reported complications” (33). Post-approval complications may go under-reported as the MAUDE database requires submission from voluntary and mandated reporters, and complication rates cannot be ascertained from this source. Additionally, full clinical details of complications are not available in the published literature or the MAUDE database. This precludes granular analysis such as the relationship between placement approach or radiation status and ProACTTM safety. Additionally, certain publications were excluded for overlapping populations with larger included studies. Though publication exclusion poses the possibility of losing important data on ProACTTM safety, we minimized this by including the larger of studies with overlapping populations.

Conclusions

Comparison of the published and “real world” safety data reveals similar complications, with the exception of a very rare, severe rectal perforation identified in the post-approval MAUDE safety database. Providers should inform patients that the most common risks ProACT placement include device failure, balloon erosion, device infection, urinary tract perforation, and urinary retention. Patients should understand that the overall complication rate according to published literature is approximately 47%, with most AEs representing CTCAE 1–2 complications.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://tau.amegroups.com/article/view/10.21037/tau-24-587/rc

Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-24-587/prf

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-24-587/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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Cite this article as: Fernandez AM, Patel HV, Li KD, Balakrishnan AS, Buie J, Ghaffar U, Hakam N, Breyer BN. Adjustable continence therapy for men (ProACTTM): systematic review and compendium of adverse events. Transl Androl Urol 2025;14(5):1476-1483. doi: 10.21037/tau-24-587

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