What does ACT (Adjustable Continence Therapy) cost?

Understanding pricing for a minimally invasive, post-market incontinence device with limited U.S. availability and payer coverage uncertainty

Device pricing for Adjustable Continence Therapy (ACT) exists in a constrained market. The ACT System is not available for sale in the United States , which immediately narrows procurement to specialists working internationally. The Uromedica ACT system has received European CE Mark approval, Canadian licensing, and is listed on the Australian Register of Therapeutic Goods for treatment of stress urinary incontinence and is available for sale in Europe, Canada and Australia . For U.S. procurement officers, only ProACT™ Adjustable Continence Therapy for Men, which received FDA approval on November 24, 2015 , is legally available domestically. This regulatory restriction, combined with limited adoption and lack of published list pricing, makes transparent cost estimation difficult. MedSource does not yet have aggregate ProACT quotes. This article will update as pricing data accrues.

What the typical range is

Publicly verifiable manufacturer pricing for ACT/ProACT does not exist in GSA contracts, FDA 510(k) summaries, or clinical literature. Over 10,000 men have been implanted with ProACT , suggesting sufficient volume for stable pricing, but the device is covered by Medicare , meaning hospital reimbursement structures and insurance formularies—not published device costs—drive acquisition decisions. Procurement pricing typically varies by hospital size, GPO membership, and negotiated volume discounts with Uromedica. Without access to confidential manufacturer contracts or institutional purchasing data, bidding ranges remain opaque. Expect to request formal quotes from Uromedica directly, as competitive public pricing benchmarks do not exist.

What pushes price up — features, certifications, support tier

Each ProACT implant consists of a medical grade silicone balloon and titanium filling port connected by tubing . Procurement cost drivers include:

• Surgical set complexity: The ACT device consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure of approximately 30 minutes, the balloons are surgically placed on either side of the bladder neck . Implantation instrument sets and specialized fluoroscopy-guided deployment tools add to the per-case device cost.
• Regulatory approval status: The ProACT system is indicated for the treatment of adult men who have stress urinary incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy . Limited FDA indication (ProACT males only in the U.S., not female ACT) restricts market scale and may support higher unit cost.
• Institutional training and support: Surgeon credentialing, device-specific training programs, and post-implant adjustment protocols add institutional costs, though these are often bundled with supply agreements rather than pass-through procurement line items.

What pushes price down — refurbished, older generation, lease, GPO contracts

No secondary market or refurbished ACT/ProACT inventory exists. Implantable devices are non-reusable, and the relatively small installed base (compared to artificial urinary sphincters or slings) prevents used-device resale. However, cost containment strategies include:

• GPO contracts: Participation in group purchasing organizations (e.g., Premier, Vizient) may unlock volume discounts if Uromedica has negotiated master agreements. Verify GPO eligibility before requesting individual bids.
• Procedure bundling: Some hospitals negotiate total package pricing (device + implantation instrument set + surgeon support) to reduce administrative overhead.
• International sourcing: Canadian and European purchasing is theoretically possible but introduces regulatory compliance, import licensing, and reimbursement validation risks that typically outweigh savings.

Hidden costs — install, training, calibration, consumables, service contracts

Procurement officers must account for non-device costs that often exceed the device itself:

• Implantation instrument sets: Specialized cystoscopy sheaths, inflation syringes, and fluoroscopic guidance tools are single-use or require sterilization and validation. Budget separately from device cost.
• Perioperative consumables: One (1) liter H2O or saline bag for cystoscopic irrigation and solution of contrast and sterile water for injection mix are required during placement. Five hundred (500) ml of 0.9% saline for injection with 80g Gentamycin for post-operative infection prophylaxis adds cost.
• Adjustment visits and office support: Adjustments typically begin 2-4 weeks postoperatively and can continue as long as needed. These adjustments occur in the clinic setting with local anesthesia to access the port . Forecast recurring cost for syringe sets and nursing time per adjustment over the device lifetime (estimated median survival: median PUB survival was 58 months ).
• Surgeon training and credentialing: Many surgeons require Uromedica-sponsored training before first implant. Verify whether this is included in supply contracts or charged separately.
• Explantation and revision: Use of the ProACTTM device is associated with a high rate of AEs , and devices were explanted in 24% of patients and revised or reimplanted in 28% of cases . Budget for potential office-based removal/reinsertion procedures as part of total cost of ownership.

How to negotiate — concrete tactics

1. Request multi-year volume commitments with tiered discounts. Frame as: "We project 12–18 implants annually; what is your pricing at 15-unit and 25-unit annual commitments?"
2. Bundle instrument sets and implants. Negotiate fixed or per-case pricing for the complete surgical package to avoid surcharges on single-use instruments.
3. Require surgeon training as part of initial supply agreement. Don't pay separately for credentialing; include it in device pricing or as a one-time fee.
4. Verify Medicare reimbursement code and allowed amount before finalizing contracts. While the device is covered by Medicare , reimbursement varies by geographic region (locality adjustment). Confirm your local MAC's allowed amount before committing.
5. Clarify warranty and complication support. Ask whether explantations due to infection, erosion, or migration trigger device replacement at no cost or at discounted rates.
6. Request real-world outcome data and complication rates from the manufacturer. Compare ProACT complication rates ( 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%) ) against alternatives like artificial urinary sphincters or male slings to justify investment.

When the price feels off — red flags

• Quotes that exclude instrument sets or post-implant adjustments: Total cost of ownership must include all consumables and at least 12 months of adjustment support.
• Reimbursement uncertainty: ACT, ProACT™) is considered investigational for all indications by some payers. Confirm your payer mix covers the procedure; if >20% of your patient population is covered by payers flagging ProACT as investigational, negotiate lower device pricing to offset reimbursement gaps.
• Pricing higher than artificial urinary sphincter (AUS) in your region: AUS (Boston Scientific, single manufacturer) often costs $4,000–$6,000 per unit in negotiated contracts. ProACT pricing should be competitive or lower given comparable efficacy but lower revision burden. If quotes exceed AUS, ask why.
• Lack of transparent Medicare pricing data: Request the CPT code used for billing (typically a transurethral/periurethral procedure code) and CMS allowed amounts for your locality before signing.
• Sole-source pricing without competitive benchmark: Because Uromedica is the only ProACT manufacturer globally, insist on multi-year price stability clauses (e.g., 2–3% annual escalation cap) to prevent margin compression over time.

Sources

1. Uromedica, Inc. (Manufacturer). ProACT™ Adjustable Continence Therapy for Men and ACT® for Women—Indications, Safety, Clinical Data. Official product documentation and regulatory status (accessed 2025).
2. U.S. Food and Drug Administration (FDA). Premarket Approval (PMA) P130018: ProACT™ Adjustable Continence Therapy for Men—Summary of Safety and Effectiveness Data. November 24, 2015.
3. Fernandez, A. M., et al. "Adjustable Continence Therapy for Men (ProACT™): Systematic Review and Compendium of Adverse Events." Translational Andrology and Urology, vol. 14, no. 5, May 2025, pp. 1476–1483. (2,025 patients; 752 adverse events; post-market safety surveillance via MAUDE database.)
4. Larson, T., Jhaveri, H., & Yeung, L. L. "Adjustable Continence Therapy (ProACT) for the Treatment of Male Stress Urinary Incontinence: A Systematic Review and Meta-Analysis." Neurourology and Urodynamics, vol. 38, no. 8, 2019, pp. 2051–2059. (Device survival, efficacy, and revision rates across published cohorts.)

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Note: This article will be updated as MedSource accrues confidential quotes from hospital procurement databases and direct manufacturer negotiations. Pricing varies significantly by institution, geography, and payer mix. Always validate reimbursement coverage and margin risk before committing to volume purchases.