ADJUSTABLE BALLOON CONTINENCE DEVICES (REQUIRES PREAUTHORIZATION)

VIII.11





VIII.11 ADJUSTABLE BALLOON CONTINENCE DEVICES (REQUIRES PREAUTHORIZATION)


Policy

I.  The Permanent Adjustable Balloon Continence Devices (e.g. ACT and ProACT therapy system) for females and males are considered Investigational for the treatment of urinary incontinence because its effectiveness has not been established.



Dates

  • Original Effective
    01-01-2020
  • Last Review
    08-09-2023
  • Next Review
    08-11-2024

Description

ProACT and ACT are minimally invasive, adjustable balloon devices designed to treat stress urinary incontinence in men and women, respectively.  These long term, implantable medical devices are designed and manufactured in the USA by Uromedica.

The ProACT system consists of two postoperatively adjustable silicone balloons placed under fluoroscopic guidance at the prostatic apex (in post-TURP individuals), or at the vesico-urethral anastomosis (in post prostatectomy individuals) in males.  Balloon titration is via tubing connected to a titanium port in the scrotum to enable post-implantation adjustments.  The balloons are filled with isotonic solution following implantation; 1ml can be titrated monthly until optimum continence is achieved.

The ACT is a device that consists of two silicone balloons filled with normal saline, placed percutaneously at the level of the bladder neck.  They will provide support both to the bladder and the urethra.  The tension inside the balloon can be adjusted in the office to provide the optimum tension to adequately control incontinence.



Quick Code Search

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Procedure

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Diagnosis

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Codes

      
          Full Description
            Transperineal periurethral balloon continence device; bilateral placement, including cystoscopy and fluoroscopy
      
          Full Description
            Transperineal periurethral balloon continence device; unilateral placement, including cystoscopy and fluoroscopy
      
          Full Description
            Transperineal periurethral balloon continence device; removal, each balloon
      
          Full Description
            Transperineal periurethral balloon continence device; adjustment of balloon(s) fluid volume
      
          Full Description
            Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance
      
          Full Description
            Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance
      
          Full Description
            Periurethral transperineal adjustable balloon continence device; removal, each balloon
      
          Full Description
            Periurethral transperineal adjustable balloon continence device; percutaneous adjustment of balloon(s) fluid volume




References

2019

Noordhoff, T.C., Finazzi-Agro, E., Scheep, J.R., Blok, B.F.M.  Outcome and complications of adjustable continences therapy (ProACT) in the treatment of urinary incontinence after transurethral resection of the prostate:  a multicenter study.   Neurourology and Urodynamics.  2019;38: 1111-1119.
2017

Chung, Eric.,  Contemporary surgrical devices for male stress urinary incontinence: a rewiew of technological advances in current continence surgery.  Transl Androl Urol, 2017;6(2): S112-S121.
2008

Gilling, P.J., Bell, D.F., Wilson, L.C. et al,.  An adjustable continence therapy device for treating incontinence after prostatectomy:  a minimum 2 year follow up.  BJUI.  2008, 102; 1426-1431. 
2006

Gregori, A., Simonato, A., Lissiani, A., et al,.  Transrectal ultrasound guided implantation of the ProACT adjustable continence therapy system in patients with post-radical prostatectomy stress urinary incontinence: a pilot study.   The Journal of Urology.  2006; 176, 2109-2113.

Revisions

12-02-2021

Adding new codes for 01/01/2022:  53451 53452 53453 53454
01-08-2020

Added Requires Preauthorization in title