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Adjustable Continence Devices

Adjustable continence devices are implants for stress urinary incontinence whose compressive or supportive effect can be changed after implantation. ATOMS, ProACT and ACT use ports; Argus washer readjustment requires small incisions, and later REMEEX adjustment requires access to its suprapubic regulator.[2][4][17] The group comprises the adjustable transobturator male system (ATOMS), the Argus and REMEEX adjustable slings, and the paired periurethral balloons sold as ProACT for men and ACT for women.[1][2]

For the comparative chooser and decision matrix, see Male Urethral Slings — chooser.

Edema resolves, compression relaxes, irradiated tissues change, and patient tolerance for obstruction varies. Adjustable devices add device-specific failure modes: ports, washers, balloons, re-tensioning mechanisms, erosion, migration and explantation.

Comparative evidence is limited. In a multicenter cohort of 294 fixed and 176 adjustable male slings (not randomized; adjustable slings were used more often in irradiated and more severe patients), follow-up was available for 126 fixed-sling and 78 adjustable-sling recipients; functional outcomes did not differ in those assessed, while infection (2.3% vs 0%) and pain (11.9% vs 1.7%) were more frequent with adjustable slings.[3] The AUA/GURS/SUFU guideline (2024) recommends that clinicians discuss the AUS with men who have mild-to-severe SUI after prostate treatment , discuss male slings for mild-to-moderate SUI , and may offer adjustable balloon devices to non-radiated men .[1] The 2026 EAU guideline makes no recommendation for adjustable male slings because added benefit from adjustability has not been shown.[23] It advises ProACT implantation only in expert centers and counseling about complications, mechanical failure and explantation .[23]

DeviceMechanismPage
ATOMSAdjustable ventral compression via subcutaneous portatoms-sling
Argus (Classic / T)Compression + mechanical washer adjustmentargus-sling
REMEEX (MRS)Compression + suprapubic varitensor; later adjustment uses an external manipulator after access to the regulatorremeex-mrs
ProACTPeriurethral balloon compression at the bladder neckproact-balloons

Indications and Patient Selection​

The common indication is persistent, bothersome stress incontinence after prostatectomy or TURP despite conservative treatment. The US ProACT label is limited to men with intrinsic sphincter deficiency persisting at least 12 months after radical prostatectomy or TURP. Contraindications include active systemic or urinary infection, detrusor overactivity or reduced bladder compliance, postvoid residual >100 mL, current or planned radiotherapy within six months or radiotherapy in the preceding six months, and bleeding disorders; check the complete IFU before implantation.[4] Guideline support differs by device class: the AUA recommends discussing the AUS across mild-to-severe SUI, recommends discussing slings for mild-to-moderate SUI, and gives adjustable balloons a Conditional Recommendation for non-radiated men; it recommends an AUS over a sling or balloon after prior pelvic radiation .[1]

Selection rests on the following variables, each of which has been associated with outcome in the cohorts below:

  • Severity. Dry rates after ProACT fell with increasing baseline severity in a TRUS-guided series (see the ProACT page); adjustable slings were used more often than fixed slings for severe incontinence in the German cohort.[3]
  • Radiation. No history of radiotherapy was a favorable prognostic factor in the 287-man European ATOMS cohort, and radiotherapy shortened failure-free survival of periurethral balloons.[5][6]
  • Prior incontinence surgery. Primary rather than secondary implantation predicted success after ATOMS, and a previous balloon placement shortened balloon survival.[5][6]
  • Manual dexterity and follow-up. Unlike the AUS, none of these devices requires patient manipulation, but all require clinic visits for adjustment.[2]

Device Design​

  • ATOMS. A transobturator system whose fillable cushion compresses the bulbar urethra ventrally; the cushion volume is changed through a port. Three port generations have been used: an inguinal port (2009–2013), an intraoperatively connected scrotal port (2013–2015) and a pre-connected, fully silicone-covered scrotal port (2014–2016). In 383 implants, Clavien IIIb complications numbered 29 with the inguinal port, 6 with the first scrotal port and 2 with the silicone-covered scrotal port, with comparable efficacy.[7]
  • Argus. A 4.2 × 2.6 × 0.9 cm silicone foam pad compresses the bulbar urethra.[8] Its columns are tensioned with washers.
  • REMEEX. A suburethral sling connected by traction threads to a suprapubic varitensor, which allows the tension to be changed after surgery with an external manipulator.[9]
  • ProACT and ACT. Two silicone balloons are placed on either side of the urethra at the bladder neck, each connected to a titanium port through which the volume is changed percutaneously.[4][2] The female ACT applies the same balloon principle in women with intrinsic sphincter deficiency, most often after failed surgery.[10]

Operative Principles​

The steps below are common to the device family. Device-specific dissection, passage and fixation follow the manufacturer's instructions and the linked device pages.

  1. Confirm the diagnosis. Document stress-predominant leakage and its severity (pad count or pad weight), and exclude untreated stricture, bladder-neck contracture or a storage disorder that would explain the symptoms.[1]
  2. Position and access. ATOMS, Argus and REMEEX are placed through a perineal incision over the bulbar urethra, with transobturator or retropubic passage of the arms or threads; ProACT is placed through small perineal incisions under fluoroscopic and endoscopic guidance in the FDA-posted technique.[7][8][9][4]
  3. Protect the urethra and bladder. The FDA-posted ProACT technique uses a catheter and cystoscope sheath as anatomical guides. If urethral perforation occurs, the balloon must not be implanted or must be removed on that side; the IFU says the perforation can be treated with a urethral Foley catheter for three days.[4]
  4. Set a conservative initial tension or fill. Leave the device at a modest setting so that voiding is preserved while edema settles.[4]
  5. Confirm voiding before discharge. If retention occurs after ProACT, the IFU calls for deflating the balloons in small increments until voiding resumes.[4]

Postoperative Adjustment​

Adjustment is deferred until healing. The ProACT IFU defers therapeutic adjustment for six weeks and then allows stepwise filling at intervals.[4] In the European ATOMS cohort, men needed a median of 3 adjustments (interquartile range 2–4).[5] In the first Argus multicenter series, 4 of 48 men (8%) needed sling readjustment.[8] The goal of each adjustment is continence with preserved voiding; retention may require reducing the fill or tension. With ProACT, new pain warrants assessment for malposition, erosion or infection rather than automatic deflation.[4]

Outcomes​

DeviceStudynFollow-upResult
ATOMSSystematic review and meta-analysis[11]1,393 (20 studies)Standardized mean 20.9 monthsNo pad or one safety pad/day 67%; improved 90%; complications 16.4% (major 3.0%); explantation 5.75%
ATOMSEuropean multicenter cohort[5]287Median 31 monthsStudy-defined success 258/287 (90%); dry 184/287 (64%: <10 mL/day and 0–1 pad/day); pads per day median 4 to 1; 56/287 (20%) of devices removed
ArgusPhase III multicenter trial[8]48Mean 7.5 monthsDry 73%; improved 10%; incontinent 17%
REMEEXFirst series, points of technique[9]6Mean 18 months5 of 6 continent
ProACTSystematic review and meta-analysis[12]1,264 (19 studies)Mean 3.6 yearsDry 60.2%; dry or improved by more than 50% 81.9%
ACT (women)Cohort[13]2811 yearComposite success 104/281 (37.0%: 0–1 pad/day plus improvement rating at least 8/10); improved 94/281 (33.5%); failed 83/281 (29.5%); explanted 64/281 (22.8%)

All of these data are observational, and the definitions of "dry" and "success" differ between studies. A 2023 ProACT update pooled 1,570 men across 18 studies (mean follow-up 34.7 months): 55.1% used 0–1 pad/day, while complications, explantation and reoperation were reported in 31.2%, 26.5% and 22.7%, respectively; study methods were heterogeneous.[19] In a meta-analysis of 41 observational studies (3,059 men), ATOMS was associated with higher dry rates than ProACT (68% vs 55%) and higher improvement (91% vs 80%); among four studies with usable durability data, the proportions of devices still working at 3 years were 81% vs 58%.[14] A second meta-analysis of 29 observational studies (1,919 men) reported dry rates of 69.3% with ATOMS and 53.4% with REMEEX, with fewer explantations after ATOMS.[15] Neither comparison is randomized.

Complications and Durability​

  • Infection and pain. In the German cohort, infection (2.3% vs 0%) and pain (11.9% vs 1.7%) were more frequent after adjustable than fixed slings.[3]
  • Port and device problems. Of 56 ATOMS removals in the European cohort, 41% were for local titanium intolerance and 30% for leak or dysfunction.[5] Port design changed the IIIb complication count in the generation study.[7]
  • Perforation and retention. These are the characteristic early events after balloon placement; rates by series are tabulated on the ProACT page.
  • Loss of efficacy. In a single-center survival analysis of 82 balloons in men and women, 41 balloons were initially effective in 36 patients; among those effective balloons, failure-free survival was 50% at 60 months. Radiotherapy, diabetes and a previous balloon placement were associated with shorter survival.[6]

Practical Positioning​

ScenarioBest fit from existing WARWIKI pages
Mild-to-moderate non-radiated SUI, residual sphincter functionFor fixed AdVance, the repositioning test may inform selection.[22] ATOMS provides adjustable ventral compression and has observational outcomes across severity strata.[11][17]
Moderate-to-severe SUIDiscuss AUS; AUA advises against routine male sling implantation in severe SUI . ATOMS has observational outcomes in this setting but no randomized comparison with AUS.[1][3]
Failed AdVance / fixed slingThe AUA guideline recommends an AUS after sling failure [1]; ATOMS has been reported as a salvage option
Patient wants a minimally invasive adjustable option and is non-radiatedProACT may be offered , with durability counseling[1]
Prior pelvic radiationThe AUA guideline recommends offering an AUS over a sling or adjustable balloon [1]; ATOMS results are lower than in non-radiated cohorts

Comparison With Alternatives​

MASTER, a randomized noninferiority trial in 380 men with urodynamic stress incontinence, compared a fixed transobturator sling with the AUS and did not include an adjustable device. The sling was noninferior for patient-reported incontinence at 12 months: 134/154 sling recipients (87.0%) and 133/158 AUS recipients (84.2%) with outcome data reported incontinence.[16] Serious adverse events numbered 6 and 13 among the 180 and 173 men operated on, respectively.[16] Comparisons of adjustable devices with AUS are observational; one small randomized trial compared Argus T with fixed AdVance (11 men randomized per arm; 11 AdVance and 9 Argus T patients included in the 18-month cure-criteria table).[18] The AUA/GURS/SUFU guideline supports AUS discussion across mild-to-severe SUI and recommends AUS over sling or balloon after radiation .[1] A narrative review of the balloon devices concluded that ProACT is safe and effective in men after prostate surgery, that its role in women and in neurogenic incontinence is unclear, and that a randomized comparison with the AUS is needed.[2]

High-Yield Differences​

  • ATOMS is used mainly outside the US. It is a transobturator device with ventral compression and port adjustment. Comparative observational studies are subject to selection and device-generation differences.
  • Argus. In longer follow-up of the original 48-man multicenter cohort, 31/47 assessed men were pad-free at a mean 45 months; six erosions (four urethral), nine sling removals (six for erosion and three for infection), and persistent perineal pain in two were reported.[24]
  • REMEEX permits suprapubic re-tensioning, and its retropubic passage carries a risk of bladder or bowel injury.
  • ProACT is a periurethral balloon system at the bladder neck and not a sling. The AUA guideline allows it for non-radiated men with mild-to-severe SUI .[1]

Adjustable Devices in Women​

ACT balloons have been used mainly for intrinsic sphincter deficiency after failed anti-incontinence surgery. A systematic review of eight studies (2007–2013) reported short pad-test values falling from 49.6–77.3 g before implantation to 11.2–25.7 g afterward.[10] At 1 year in the 281-woman cohort, 37.0% were classed as successes and 29.5% as failures.[13] A 2023 review of 13 female ACT case series for stress incontinence due to intrinsic sphincter deficiency reported success rates of 13.6–68%, intraoperative perforation in 3.5–25%, and explantation in 6–38%; definitions and follow-up varied.[20] The female ACT series lack active comparators.[2][20] The 2026 EAU guideline recommends mechanical devices for uncomplicated mild-to-moderate SUI only in closely monitored research , and recommends counseling ACT recipients about the high risk of complications, mechanical failure and explantation .[21] Female adjustable slings and ACT are discussed with the other options on the Female SUI database.

Launch Note​

The device-specific pages carry the details and references.

See Also​

Videos​

ProACT Adjustable Continence Therapy for Men
Operative video, Uromedica
ATOMS for Male Urinary Incontinence
Operative video, Dr. Bhavatej Enganti

References​

1. Breyer BN, Kim SK, Kirkby E, et al. Updates to Incontinence After Prostate Treatment: AUA/GURS/SUFU Guideline (2024). J Urol. 2024;212(4):531–538. doi:10.1097/JU.0000000000004088

2. den Hoedt S, Blok BFM. "Adjustable Continence Therapy (ProACT/ACT) With Periurethral Balloons for Treatment of Stress Urinary Incontinence: A Narrative Review." Transl Androl Urol. 2024;13(8):1744–1761. doi:10.21037/tau-22-807. PMID 39280649

3. Hüsch T, Kretschmer A, Obaje A, et al. Fixed or adjustable sling in the treatment of male stress urinary incontinence: results from a large cohort study. Transl Androl Urol. 2020;9(3):1099–1107. doi:10.21037/tau-19-852

4. US Food and Drug Administration. ProACT Physician Instructions for Use, PMA P130018. FDA-posted IFU. Manufacturer labeling.

5. Friedl A, Mühlstädt S, Zachoval R, et al. "Long-Term Outcome of the Adjustable Transobturator Male System (ATOMS): Results of a European Multicentre Study." BJU Int. 2017;119(5):785–792. doi:10.1111/bju.13684

6. Bajeot AS, Brierre T, Beauval JB, et al. "Survival Analysis of Adjustable Continence Therapy Device (ACT/proACT): A New Message for Patients." Prog Urol. 2021;31(4):215–222. doi:10.1016/j.purol.2020.10.005. PMID 33339737

7. Mühlstädt S, Friedl A, Zachoval R, et al. "An Overview of the ATOMS Generations: Port Types, Functionality and Risk Factors." World J Urol. 2019;37(8):1679–1686. doi:10.1007/s00345-018-2548-4

8. Romano SV, Metrebian SE, Vaz F, et al. "An Adjustable Male Sling for Treating Urinary Incontinence After Prostatectomy: A Phase III Multicentre Trial." BJU Int. 2006;97(3):533–539. doi:10.1111/j.1464-410X.2006.06002.x

9. Sousa-Escandón A, Rodríguez Gómez JI, Uribarri González C, Marqués-Queimadelos A. "Externally Readjustable Sling for Treatment of Male Stress Urinary Incontinence: Points of Technique and Preliminary Results." J Endourol. 2004;18(1):113–118. doi:10.1089/089277904322836776. PMID 15006064

10. Phé V, Nguyen K, Rouprêt M, Cardot V, Parra J, Chartier-Kastler E. "A Systematic Review of the Treatment for Female Stress Urinary Incontinence by ACT Balloon Placement (Uromedica, Irvine, CA, USA)." World J Urol. 2014;32(2):495–505. doi:10.1007/s00345-013-1117-0

11. Esquinas C, Angulo JC. "Effectiveness of Adjustable Transobturator Male System (ATOMS) to Treat Male Stress Incontinence: A Systematic Review and Meta-Analysis." Adv Ther. 2019;36(2):426–441. doi:10.1007/s12325-018-0852-4

12. Larson T, Jhaveri H, Yeung LL. "Adjustable Continence Therapy (ProACT) for the Treatment of Male Stress Urinary Incontinence: A Systematic Review and Meta-Analysis." Neurourol Urodyn. 2019;38(8):2051–2059. doi:10.1002/nau.24135

13. de Guerry ML, Demeestere A, Bergot C, et al. "Adjustable Continence Therapy (ACT) Balloons to Treat Female Stress Urinary Incontinence: Effectiveness, Safety and Risk Factors of Failure and Complication." Int Urogynecol J. 2023;34:877–883. doi:10.1007/s00192-022-05275-6

14. Angulo JC, Schönburg S, Giammò A, et al. "Systematic Review and Meta-Analysis Comparing Adjustable Transobturator Male System (ATOMS) and Adjustable Continence Therapy (ProACT) for Male Stress Incontinence." PLoS One. 2019;14(12):e0225762. doi:10.1371/journal.pone.0225762

15. Angulo JC, Ruiz S, Lozano M, et al. "Systematic Review and Meta-Analysis Comparing Adjustable Transobturator Male System (ATOMS) and Male Readjustment Mechanical External (REMEEX) System for Post-Prostatectomy Incontinence." World J Urol. 2021;39(4):1083–1092. doi:10.1007/s00345-020-03300-1

16. Abrams P, Constable LD, Cooper D, et al. "Outcomes of a Noninferiority Randomised Controlled Trial of Surgery for Men with Urodynamic Stress Incontinence After Prostate Surgery (MASTER)." Eur Urol. 2021;79(6):812–823. doi:10.1016/j.eururo.2021.01.024. PMC8175331

17. Chung E. "Contemporary male slings for stress urinary incontinence: advances in device technology and refinements in surgical techniques." Ther Adv Urol. 2023;15:1–9. doi:10.1177/17562872231187199

18. Lima JPC, Pompeo ACL, Bezerra CA. "Argus T versus Advance sling for postprostatectomy urinary incontinence: a randomized clinical trial." Int Braz J Urol. 2016;42(3):531–539. doi:10.1590/S1677-5538.IBJU.2015.0075

19. Tricard T, Song QX, Munier P, et al. "Adjustable continence therapy (proACT) for the treatment of male stress urinary incontinence post-prostatectomy: a systematic review and meta-analysis (2023 update)." World J Urol. 2023;41(7):1793–1802. doi:10.1007/s00345-023-04452-6

20. Guérin S, Khene ZE, Peyronnet B. "Adjustable Continence Therapy Balloons in Female Patients with Stress Urinary Incontinence: A Systematic Review." Urol Int. 2023;107(7):653–665. doi:10.1159/000529712

21. European Association of Urology. "EAU Guidelines on Non-neurogenic Female LUTS: Disease Management." EAU Guidelines Office, Arnhem; 2026. Guideline chapter

22. Bauer RM, Gozzi C, Roosen A, et al. "Impact of the Repositioning Test on Postoperative Outcome of Retroluminar Transobturator Male Sling Implantation." Urol Int. 2013;90(3):334–338. doi:10.1159/000347123

23. European Association of Urology. "EAU Guidelines on the Management of Non-neurogenic Male LUTS: Disease Management." EAU Guidelines Office, Arnhem; 2026. Guideline chapter

24. Romano SV, Metrebian SE, Vaz F, et al. "Resultados a largo plazo del estudio multicéntrico fase III del tratamiento de la incontinencia de orina post prostatectomía con un sling masculino ajustable: seguimiento mínimo 3 años." Actas Urol Esp. 2009;33(3):309–314. doi:10.1016/S0210-4806(09)74146-4