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

 

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

2,3,4

 

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.

REIMBURSEMENT INFORMATION

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
     

PHYSICIAN CPT© CODES:
Category III codes have no specific RVUs or payment rates under the Medicare Physician Fee Schedule. We recommend that physicians contact their local Medicare Administrative Contractor (MAC) to request a fee assignment for CPT codes 0548T – 0551T.

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.

1840 BERKSHIRE LN N

PLYMOUTH, MN 55441

763-694-9880

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