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ProACT — Adjustable Continence Therapy (Periurethral Balloons)

The ProACT (Adjustable Continence Therapy) system uses paired periurethral balloons for male SUI. FDA approval covers adult men with intrinsic-sphincter-deficiency SUI lasting at least 12 months after radical prostatectomy or TURP despite conservative therapy.[14] See the device page for labeling, contraindications and handling. Older systematic reviews provide historical context, rather than a current regulatory indication.[1][3]

For positioning vs other minimally invasive male SUI options, see Male Urethral Slings — chooser.

ProACT is not a sling — it is a periurethral balloon system. The device works by focal compression at the bladder neck, not by repositioning or by suburethral compression along the bulbar urethra.

Device design and mechanism​

Two silicone balloons placed bilaterally at the bladder neck augment urethral coaptation through titrated focal compression — not circumferential occlusion. Each balloon connects via a conduit to a titanium port placed in the scrotum, allowing percutaneous volume adjustment under local anesthesia in clinic.[1][2]

Surgical technique​

  • General or local anesthesia.
  • The FDA-posted implantation instructions describe fluoroscopic placement; TRUS and cystoscopic techniques have also been reported. Observational series do not establish that these guidance methods are equivalent. Follow device-specific training and the supplied IFU.[2][3][14]
  • Balloons begin at low fill volume and are progressively titrated in clinic over multiple sessions to achieve continence without retention.
  • Intraoperative bladder perforation occurs in ~ 2.5% of cases; transient retention in ~ 1.2%.[2]

Efficacy​

The systematic reviews below principally synthesize observational cohorts; they do not establish randomized comparative superiority.

StudyDesign / nFollow-upKey outcome
Larson 2019 meta[5]SR/meta of 19 studies, n = 1,264Mean 3.6 yrPads/day 4.0 → 1.1; dry rate 60.2%; dry-or-improved 81.9%; I-QOL +30.8
Tricard 2023 meta[6]Updated SR/meta, 18 studies, n = 1,570Mean ~ 3 yrSocial continence 53% using 0–1 pads/day; this permits a safety pad
Nash 2019 (FDA pivotal)[7]Prospective, n = 684 yr24-h pad weight 293 → 73 g; 1 procedure-related serious AE
Finazzi Agrò 2019 multicenter[8]National Italian, n = 24024 mo (152 pts to 5 yr)29.6% dry / 37.5% improved (67.1% combined); maintained at 5 yr
Nestler 2019 long-term[9]Single-center, n = 134Median 118 mo82.6% initial success; 77.8% success after repeat implantation

Efficacy by severity​

Outcomes are stratified — mild 85% dry / moderate 63.6% / severe 33.3% in the Gregori TRUS-guided series.[2] These are cohort-specific findings, not universal severity cutoffs; AUA 2024 allows consideration across mild through severe SUI in non-radiated patients.[15]

Complications and durability​

Overall complication rate 22.5–31.2% across series.[6][8] A 2025 SR of 1,607 patients catalogued 752 adverse events — the following percentages use 752 events as the denominator, not 1,607 patients:[10]

  • Mechanical / balloon failure — 30%
  • Device migration / malposition — 21%
  • Device erosion — 16%
MetricValue
Explantation rate24–26.5%[6][11]
Reoperation rate22.7–34%[4][6]
Working device at 1 / 2 / 3 yr76% / 61% / 58%[11]

Reintervention is an important counseling issue. ATOMS working-device estimates were 92% / 85% / 81% at 1 / 2 / 3 years in Angulo 2019, but this was an indirect comparison of separate observational cohorts with differing follow-up, rather than a controlled device-survival comparison.[11]

Negative predictive factors​

  • Prior pelvic radiotherapy is the most consistent negative predictor — dryness ~ 35–46% irradiated vs ~ 66–68% non-irradiated, and significantly higher urethral-erosion rates (p = 0.005). Multiple reviews advise against use in irradiated patients.[2][3][6][12]
  • Baseline severity should inform expectations, but severity-specific results vary and should not be converted into an absolute eligibility threshold.[2][15]

Salvage role after failed sling​

Munier 2020 — n = 26 with persistent SUI after a prior sling failure: 66.7% continence and 96.3% improvement with ProACT, supporting feasibility as a salvage option when AUS is undesired or contraindicated.[13]

Comparative evidence — ATOMS-vs-ProACT meta​

The Angulo 2019 meta-analysis pooled 41 observational studies (3,059 patients), with no direct comparative trial. Pooled estimates favored ATOMS for several outcomes, but unequal follow-up, heterogeneity and selection differences limit causal interpretation. Overall complications were 17% versus 26% (p = 0.07), so a statistically established advantage across every endpoint is incorrect:[11]

EndpointATOMSProACTp
Dryness68%55%0.01
Improvement91%80%0.007
Satisfaction87%56%0.002
Explantation5%24%< 0.001
Working device 3 yr81%58%—

Current positioning​

AUA/GURS/SUFU 2024 permits offering adjustable balloons to non-radiated men with mild through severe SUI after prostate treatment (conditional recommendation, Grade C). Discuss an AUS and other appropriate alternatives, manual dexterity, adjustment visits and revision risk. After radiotherapy, the guideline favors AUS over balloons or male slings.[15] Notably, ~ 29% of ProACT patients in one series ultimately required AUS — counsel that it is a step on the ladder, not necessarily a definitive endpoint.[4]

See Also​

Videos​

ProACT Adjustable Continence Therapy for Men: Surgical Video
Uromedica (2021)

References​

1. Silva LA, Andriolo RB, Atallah ÁN, da Silva EM. Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery. Cochrane Database Syst Rev. 2014;(9):CD008306. doi:10.1002/14651858.CD008306.pub3

2. Gregori A, Romanò AL, Scieri F, et al. Transrectal ultrasound-guided implantation of adjustable continence therapy (ProACT): surgical technique and clinical results after a mean follow-up of 2 years. Eur Urol. 2010;57(3):430–436. doi:10.1016/j.eururo.2009.11.031

3. 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

4. Ricard H, Léon G, Branchereau J, et al. Adjustable continence balloons in postprostatectomy incontinence: outcomes and complications. Neurourol Urodyn. 2022;41(6):1414–1422. doi:10.1002/nau.24967

5. 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

6. 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

7. Nash S, Aboseif S, Gilling P, et al. Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT. Neurourol Urodyn. 2019;38(1):248–253. doi:10.1002/nau.23838

8. Finazzi Agrò E, Gregori A, Bianchi D, et al. 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. Neurourol Urodyn. 2019;38(7):1979–1984. doi:10.1002/nau.24103

9. Nestler S, Thomas C, Neisius A, et al. Long-term results of ProACT primary and repeat implantation for treatment of stress urinary incontinence in men. World J Urol. 2019;37(6):1173–1179. doi:10.1007/s00345-018-2483-4

10. Fernandez AM, Patel HV, Li KD, et al. Adjustable continence therapy for men (ProACT): systematic review and compendium of adverse events. Transl Androl Urol. 2025;14(5):1476–1483. doi:10.21037/tau-24-587

11. 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

12. Rouprêt M, Misraï V, Gosseine PN, et al. Management of stress urinary incontinence following prostate surgery with minimally invasive adjustable continence balloon implants: functional results from a single center prospective study. J Urol. 2011;186(1):198–203. doi:10.1016/j.juro.2011.03.016

13. Munier P, Nicolas M, Tricard T, et al. 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. Neurourol Urodyn. 2020;39(5):1417–1422. doi:10.1002/nau.24355

14. US Food and Drug Administration. ProACT PMA P130018, approved November 24, 2015. Approval record; physician IFU, Rev A.

15. AUA/GURS/SUFU. Incontinence After Prostate Treatment Guideline, amended 2024, statements 22 and 24. Guideline.