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PROCEDURE INFORMATION

PROCEDURE INFORMATION

INDICATION:

ProACT is indicated for the treatment of adult men who have stress 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.

OVERVIEW OF PROCEDURE:

The ProACT device consists of two post-operatively adjustable balloon implants placed bilaterally in a periurethral position via two perineal incisions, one on each side of the midline. A U-channel sheath is used to house a sharp-tipped trocar that is advanced through the pelvic floor. A blunt trocar is switched for the sharp to progress to the bladder neck. The balloons are delivered using the sheath at the bladder neck or at the apex of the prostatic remnant (in the case of a TURP patient). Self-sealing titanium ports attached via tubing to each balloon are placed subcutaneously in the scrotum and allow for post-operative volume adjustments in the office to meet long-term patient needs. Increasing the balloon volume increases coaptation of the urethra which improves continence.

CLINICAL RESULTS

CINICAL RESULTS

OVERVIEW:

ProACT gained FDA approval after a PMA study on 124 patients. In addition to the PMA study, ProACT has over forty publications from both Europe and the United States. These publications have demonstrated that ProACT provides significant clinical improvement in patients who become incontinent after a radical prostatectomy or TURP.
In 2019, a systematic review and meta-analysis on ProACT was published. The meta-analysis includes 19 studies with 1,264 patients and a total of 4,517 patient years of follow up data. The mean follow-up time was 3.6 years.

STUDY RESULTS:

  • Patient incontinence quality of life (IQOL) scores improved an average of 30.8 points (66.2%) from baseline. 

  • Patients pad per day (PPD) was reduced from an average of 4.0 PPD at baseline to 1.1 PPD. 

  • Across all studies, 60.2% patients were considered “dry” (One pad or less) and 81.9% patients were “dry” or improved greater than 50%¹.
    Common ProACT explant causes (estimate 95% CI)¹:

  • Device erosion – 3.8% (2.3%-6.2%)

  • Device leaking – 4.1% (1.7-9.6%)

  • Migration – 6.5% (3.7-11.1%)

  • Overall revision rate – 22.2% (15.2%-31.2%)

 

Unlike other incontinence therapies, the ProACT systems allows for long term adjustability. The balloon volume can be increased or decreased months and even years after the procedure. The balloon volumes are customized to meet the patient's changing continence needs. Adjustments are completed in the office using a needle stick to access the subcutaneous port. The ProACT system can also be removed in a short, office procedure using topical anesthesia posing only minor risk.

PHYSICIAN FAQ'S

  • KEY RESOURCES
    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. 06 April 2020:1-6. doi:10.1002/nau.24355 Noordhoff TC, Finazzi-Agrò E, Scheepe JR, Blok BFM. Outcome and complications of adjustable continence therapy (ProACTTM) in the treatment of urinary incontinence after transurethral resection of the prostate: A multicenter study. Neurourol Urodyn. 2019 Apr;38(4):1111-1119. doi: 10.1002/nau.23966. Larson T, Jhaveri H, Yeung LL. Adjustable continence therapy (ProACT) for the treatment of male stress urinary incontinence: A systematic review and metaanalysis. Neurourology and Urodynamics. 2019; 38(8):2051-2059. doi: 10.1002/nau.2413. 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 Sep;38(7):1979-1984. doi: 10.1002/nau.24103. Nash S, Aboseif S, Gilling P, Gretzer M, Samowitz H, Rose M, Slutsky J, Siegel S, Tu LM. 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.
  • FAQs
    I am incontinent after prostate surgery. How long should I wait to consider ProACT: Most urologists suggest doing pelvic floor exercises for at least 12 months. If after this period there is no improvement, you may want to consult a urologist regarding your treatment options. What is the Difference between a male sling and ProACT? A male sling is a long strip of woven polypropylene mesh that is used to compress or reposition the urethra. Mesh devices require an invasive surgery for placement and may require extensive surgery to remove. The ProACT device consists of two small balloons made of silicone, not polypropylene mesh, which are attached by tubing to a filling port placed under the skin of the scrotum. ProACT can be simply adjusted to better fit the patient’s individual needs in the doctor’s office and does not require additional surgery. What is the difference between an artificial urinary sphincter (AUS) and ProACT? The artificial urinary sphincter is a device consisting of three main components: the cuff to constrict the urethra, the pressure regulation balloon, and the pump with tubing connecting these components. The implant procedure for an AUS is more complex and invasive than the insertion of ProACT. The AUS cannot be adjusted post-operatively to the needs of the individual patient and removal of this device requires an extensive surgery. In addition, patients with an AUS must manipulate a pump located in the scrotum every time they need to void. ProACT can be adjusted to the needs of the individual patient. The physician injects fluid into the port of the balloon in a brief office adjustment. With ProACT, the patient urinates naturally. No patient manipulation is required. How many men have been implanted with ProACT? This therapy had been commercially available since 2002 outside the USA and has been available within the USA since 2015. To date, over 10,000 men have been implanted with ProACT. What should I expect after ProACT implantation? After your ProACT surgery, your doctor will adjust your device in brief office visits to better suit your individual needs. These adjustments are intended to improve your continence. You may see an improvement right away, although it could take six months or longer to reach maximum effectiveness. What if ProACT doesn’t work for me? If you see no improvement with ProACT, it can be removed at any time. The balloons are deflated and removed in an office setting with no invasive surgery required. After it is removed, you can be re-implanted with ProACT or pursue other therapy options.

2,3,4

PHYSICIANFAQ

REIMBURSEMENT INFORMATION

REIMBURSEMENT INFORMATION

SOURCES

1 Nash S, Aboseif S, Gilling P, Gretzer M, Samowitz H, Rose M, Slutsky J, Siegel S, Tu LM. Treatment with an adjustable long-term implant for post-prostatectomy stress incontinence: The ProACT pivotal trial. Neurourol Urodyn. 2018; 37(8): 2854-2859.

2 Noordhoff T, Scheepe J, Blok B. Outcome and complications of adjustable continence therapy (ProACT™) after radical prostatectomy: 10 years’ experience in 143 patients. Neurourol Urodyn. 2018; 37(4):1419-1425.

3 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):2051-59.

4 Nash S, Aboseif S, Gilling P, Gretzer M, Samowitz H, Rose M, Slutsky J, Siegel S, Tu LM. 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.

5 Nestler S, Thomas C, Neisius A, Rubenwolf P, Roos F, Hampel C, Thüroff JW. Long term results of ProACT primary and repeat implantation for treatment of stress urinary incontinence in men. World J Urol. 2019 Jun;37(6):1173-1179.

6 Kjaer L, Fode M, Norgaard N, Sonksen J, and Nordling J. Adjustable continence balloons: Clinical results of a new minimally invasive treatment for male urinary incontinence. Scand J Urol Nephrol. 2012; 46(3):196-200.

7. Roupret M, Vincent M, Pierre-Nicolas G, Stephane B, Florence C, Emmanuel CK 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 July;Vol 186, 198-203 DOI:10.1016/j.juro.2011.03.016.

FDA INDICATION:

The ProACT™ Adjustable Continence Device Therapy for Men is indicated for the treatment of adult men who have stress 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.

DIAGNOSIS CODING:

The following are commonly billed diagnosis codes for the ProACT implant procedure

  • N39.3 Stress incontinence 

  • N39.4X Other specified urinary incontinence

  • N39.46 Mixed incontinence

2023 FACILITY CODING

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Allowed amounts based on CMS-1772-FC 2023 OPPS and ASC Final Rule.

Note: CPT Codes 53451 and 53452 are device-intensive codes and require a device code to be billed on hospital outpatient claims. Hospitals may use the unlisted device code C1889, Implantable/insertable device, not otherwise classified, to report the ProACT device. Unlisted codes like C1889 typically require manual charge entry. It is very important that hospitals report C-Codes as well as the associated device costs. This will help inform and potentially increase future hospital outpatient payment rates.

2022 Professional reimbursement.PNG

2023 PHYSICIAN CPT© CODES:

* National relative values are not established for codes 53451-53454. Medicare Administrative Contractors (MACs) and private insurers establish payment. Contact reimbursement@uromedica-inc.com for an estimate of the physician payment in your locale.

 

If you need assistance with coding, pre-authorizations or appeals for the ProACT™ procedure please e-mail or call and we will respond to your inquiry as soon as possible:

Reimbursement@uromedica-inc.com 

Phone: 763-694-9880
 

Reimbursement Materials Available On Request:

  • ProACT Reimbursement Guide

  • ProACT commonly billed codes

  • Sample physician fee and crosswalk letter

  • Sample letter of medical necessity

  • Sample claims appeal letter

Disclaimer: This information is provided for reference purposes only and does not constitute medical, legal, or coding advice. Uromedica, Inc. makes no guarantees about coverage or payment amounts. It is the provider’s responsibility to determine medical necessity and appropriate site of service and to submit appropriate codes, modifiers, and charges for services rendered. Please contact your local payer/carrier and or compliance counsel for interpretation of coding and coverage. Uromedica, Inc. encourages providers to submit claims consistent with FDA-approved labeling. CPT is copyright the American Medical Association.

PRO-US-20-009

SOURCES:

1 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):2051-59.

2 Nestler S, Thomas C, Neisius A, Rubenwolf P, Roos F, Hampel C, Thüroff JW. Long term results of ProACT primary and repeat implantation for treatment of stress urinary incontinence in men. World J Urol. 2019 Jun;37(6):1173-1179.

3 Kjaer L, Fode M, Norgaard N, Sonksen J, and Nordling J. Adjustable continence balloons: Clinical results of a new minimally invasive treatment for male urinary incontinence. Scand J Urol Nephrol. 2012; 46(3):196-200.

4. Roupret M, Vincent M, Pierre-Nicolas G, Stephane B, Florence C, Emmanuel CK 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 July;Vol 186, 198-203 DOI:10.1016/j.juro.2011.03.016.

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