ProACT — Adjustable Periurethral Balloon System
The ProACT (Adjustable Continence Therapy) system is a paired silicone periurethral balloon device implanted bilaterally at the male bladder neck to augment urethral coaptation through focal compression. FDA-approved 2015 (US); CE-marked 2000 (Europe). Originally developed by Uromedica; currently distributed by Laborie.[1][2]
This page covers the device itself. For implantation technique, titration, efficacy by severity, complication profile, and positioning vs male slings and the AUS, see ProACT (procedure).
Device Design & Components
Each ProACT unit comprises three connected components:[1][2][3]
- Silicone balloon — single-lumen, kink-resistant, designed for percutaneous fill titration. Implanted at the bladder-neck level, lateral to the urethra (one on each side).
- Conduit tubing — silicone, tunneled subcutaneously from the balloon to the scrotal port.
- Titanium injection port — placed in the dependent scrotum, palpable for office-based percutaneous adjustment under local anesthesia.
The balloons are filled with an isotonic radiopaque solution (typically iso-osmolar contrast medium — eg iohexol) allowing fluoroscopic localization and volume verification at adjustment visits. Final fill volume ranges from 0.5–8 mL per balloon depending on continence response.[1][3]
The device is paired: two complete balloon-tubing-port units (one per side) are implanted in a single procedure.
Mechanism
ProACT works through bilateral focal compression at the bladder neck, augmenting passive urethral coaptation rather than encircling the urethra. This is mechanistically distinct from:
- AUS (AMS 800) — circumferential cuff occlusion at the bulbar urethra.
- Male slings (AdVance, Virtue, ATOMS, Argus) — suburethral support or compression along the bulbar urethra.
- Adjustable male slings (ATOMS, Remeex) — postoperatively titratable suburethral compression.
The adjustability is the device's defining feature: balloon volume can be tuned in clinic over weeks-to-months, allowing graded continence titration without revision surgery.
Materials
| Component | Material | Notes |
|---|---|---|
| Balloon | Medical-grade silicone elastomer | Selected for elasticity, biocompatibility, low capsule formation |
| Tubing | Silicone | Reinforced to resist kinking through subcutaneous tunnel |
| Port | Titanium | MR-conditional; palpable for percutaneous needle access |
| Fill solution | Iso-osmolar radiocontrast (eg iohexol) | Permits fluoroscopic volume verification |
The all-silicone-and-titanium construction is MR-conditional under standard 1.5T and 3T scanning protocols with appropriate manufacturer-defined conditions; magnetic-field interaction with the titanium port is minimal.[3]
Indications
- Male post-prostatectomy SUI (radical prostatectomy, simple prostatectomy, HIFU, TURP).[1][2][4]
- Selected post-radiation SUI — though radiation is consistently associated with higher complications and lower dry rates.[5][6]
- Mild-to-moderate severity — best outcomes (mild 85% dry / moderate 64% / severe 33% in Gregori TRUS-guided series).[2]
- Patients seeking a minimally invasive option who decline or are not candidates for AUS.
Contraindications / Cautions
- Active urinary tract infection.
- Severe bladder-outlet obstruction or untreated detrusor overactivity.
- Prior bladder-neck reconstruction or significant bladder-neck contracture.
- Pelvic radiation relative contraindication: erosion rate ~ 2–3× non-radiated cohorts.[5]
Comparative Positioning (Device-Level)
| Device | Mechanism | Adjustable? | Continence severity range |
|---|---|---|---|
| AMS 800 AUS | Circumferential bulbar cuff | Patient-activated (per void) | Moderate–severe |
| AdVance / AdVance XP | Suburethral repositioning sling | No | Mild–moderate |
| Virtue | Quadratic suburethral compression | No | Mild–moderate |
| ATOMS | Adjustable suburethral cushion + scrotal port | Postop titrated | Mild–moderate (some severe) |
| Argus | Static silicone-cushion compression with washer tensioning | Intraop only | Mild–severe |
| Remeex | Suprapubic readjustable tensioning device | Postop titrated | Mild–severe |
| ProACT | Paired periurethral balloon focal compression at bladder neck | Postop titrated | Mild–moderate |
Among device-level alternatives, ProACT's distinguishing features are (1) bilateral bladder-neck location (vs all other devices, which act on the bulbar urethra), (2) percutaneous office-based titration without revision, and (3) a lower invasiveness profile at index implantation. Trade-offs include a higher long-term explantation rate (24–27%) and mechanical-balloon-failure mode (30% of adverse events).[7][8]
Manufacturer & Regulatory Timeline
- 2000 — first European clinical implants (Uromedica).
- 2001 — CE mark.
- 2015 — FDA approval for male post-prostatectomy SUI based on the Nash pivotal trial.[6]
- 2018 — acquired by Laborie with global commercial distribution.
Failure Modes
- Mechanical balloon failure — fluid loss through valve or balloon-wall fatigue (~ 30% of catalogued AEs in 2025 SR).[7]
- Migration / malposition — usually inferior displacement away from the bladder neck (~ 21%).
- Erosion — into the urethra, bladder, or rectum (~ 16%); higher in radiated patients.
- Infection — port-pocket or device-deep infection mandating explant.
Repeat ProACT implantation after first-device explant has acceptable salvage success (Nestler 77.8% after repeat).[9] Conversion to AUS after ProACT failure is feasible; the prior pocket and tunneling do not preclude subsequent AUS placement.[10]
References
1. Hübner WA, Schlarp OM. "Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy." BJU Int. 2005;96(4):587–94. doi:10.1111/j.1464-410X.2005.05689.x
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):430–6. doi:10.1016/j.eururo.2009.11.038
3. Trigo Rocha F, Gomes CM, Mitre AI, Arap S, Srougi M. "A prospective study evaluating the efficacy of the artificial sphincter AMS 800 for the treatment of postradical prostatectomy urinary incontinence and the correlation between preoperative urodynamic and surgical outcomes." Urology. 2008;71(1):85–9. doi:10.1016/j.urology.2007.09.009
4. Lebret T, Cour F, Benchetrit J, et al. "Treatment of postprostatectomy stress urinary incontinence using a minimally invasive adjustable continence balloon device." Urology. 2008;71(2):256–60. doi:10.1016/j.urology.2007.08.062
5. Crivellaro S, Singla N, Kocjancic E, Yeung LL, Eldefrawy A, Gousse A. "Adjustable continence therapy (ProACT) and bone anchored male sling: comparison of two new treatments of post prostatectomy incontinence." Int J Urol. 2008;15(10):910–4. doi:10.1111/j.1442-2042.2008.02161.x
6. 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):248–53. doi:10.1002/nau.23838
7. Tricard T, Munier P, Story F, Lang H, Saussine C. "Adjustable continence balloons in postprostatectomy incontinence: outcomes and complications." Neurourol Urodyn. 2023;42(1):143–50. doi:10.1002/nau.25062
8. Larson T, Jhaveri J, 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):2051–9. doi:10.1002/nau.24135
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):1173–9. doi:10.1007/s00345-018-2483-4
10. Venturino L, Boschian R, Camerota TC, et al. "Adjustable continence balloons in men: adjustments do not translate into long-term continence." Urology. 2015;85(6):1448–52. doi:10.1016/j.urology.2015.02.029