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ProACT — Adjustable Periurethral Balloon System

ProACT, manufactured by Uromedica and listed in Coloplast's US portfolio, uses two silicone balloons beside the bladder neck. Tubing connects each balloon to a scrotal titanium adjustment port. The clinician adjusts compression through the ports; the patient does not operate a pump to void.[1][2]

For implantation, outcomes and comparison with other continence procedures, see ProACT (procedure).

Eligibility​

FDA approval dated November 24, 2015 covers adult men with intrinsic-sphincter-deficiency SUI persisting at least 12 months after radical prostatectomy or TURP, despite conservative therapy.[3]

AUA/GURS/SUFU 2024 permits offering adjustable balloons to non-radiated men with mild through severe SUI (conditional recommendation, Grade C). This is a shared-decision option with substantial revision or explantation risk; it does not establish equivalence to an AUS. For SUI after pelvic radiotherapy, the guideline favors AUS over balloons or male slings.[4]

Handling and safety​

The FDA-posted physician IFU lists the following contraindications: active systemic or urinary infection; incontinence from detrusor overactivity; poor compliance; PVR greater than 100 mL; primary urgency incontinence; suspected bladder cancer; untreated bladder stones; bleeding disorders; and radiotherapy within the preceding or coming six months, or ongoing treatment. The guideline avoids prior radiotherapy more broadly than the IFU's six-month window.[2][4]

  • Fill with isotonic saline or contrast correctly diluted according to the IFU. Iohexol is not inherently iso-osmolar. Maintain the same inflation medium during adjustments.
  • Maximum 8 mL per balloon; 23-gauge adjustment needle. Excess volume or the wrong needle can damage the device.
  • The implant is MR Conditional. MRI staff must check the model-specific IFU and all scanning conditions; field strength alone does not establish safety.
  • Implantation requires device-specific training. Use the IFU supplied with the actual implant; the FDA reference below is the original approval document.[2]

Failure and subsequent treatment​

Counsel about mechanical leakage or failure, migration, erosion, infection, retention and possible reoperation. In a 2025 systematic review, mechanical failure, migration and erosion accounted for 30%, 21% and 16% of 752 reported adverse events, respectively. These are shares of events, not individual patient risks. The procedure page discusses denominators and limitations.[5]

References​

1. Coloplast. ProACT Adjustable Continence Therapy for Men — by Uromedica. US product information. Accessed September 11, 2026.

2. Uromedica. ProACT Physician Instructions for Use, P/N 900136 Rev A. FDA approval labeling. Consult the implant's supplied IFU for current model-specific instructions.

3. US Food and Drug Administration. ProACT Adjustable Continence Therapy for Men: PMA P130018. Approval November 24, 2015. Approval record.

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

5. 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.