Medical Policies - Surgery


Implanted Adjustable Continence Therapy

Number:SUR701.036

Effective Date:06-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Implanted adjustable continence therapy is considered experimental, investigational and/or unproven as a minimally invasive treatment for urinary incontinence in adult men or women.

Description:

Urinary incontinence is the involuntary leakage of urine with loss or weakened control over the urinary sphincter. It is believed that urinary incontinence is underdiagnosed and underreported problem. Typically, urinary incontinence increases with age and is more common in females than in males. (1)

Background

A quarter to a third of men and women in the U.S. suffer from urinary incontinence. About 33 million have overactive bladder representing symptoms of urgency, frequency and with or without urge incontinence. (2)

There are several types of urinary incontinence (3):

Stress: Urine leakage associated with increased abdominal pressure from laughing, sneezing, coughing, climbing stairs, or other physical stressors on the abdominal cavity and, thus, the bladder.

Urge: Involuntary leakage accompanied by or immediately preceded by urgency (e.g., overactive bladder).

Mixed: A combination of stress and urge incontinence, marked by involuntary leakage associated with urgency and with exertion, effort, sneezing, or coughing.

Functional: The inability to hold urine due to reasons other than neuro-urologic and lower urinary tract dysfunction (e.g., delirium, psychiatric disorders, urinary infection, impaired mobility).

Overflow: The bladder is full, is unable to empty and leaks; frequent small urinations and constant dribbling are symptoms.

Urinary incontinence is treated with a variety of modalities and therapies, including medications, physiotherapy, behavioral programs, lifestyle changes, surgical corrections, and/or devices (e.g., absorbent products, catheterization regimens/diversions, etc.).

The ProACT™ adjustable continence therapy system for men and the ACT™ adjustable continence therapy system for women are indicated for the treatment of stress urinary incontinence (SUI) arising from intrinsic sphincter deficiency (ISD). (5) For adult men, SUI has been ongoing for at least 12 months’ duration following radical prostatectomy or transurethral resection of the prostate and have failed to respond adequately to conservative therapy. For adult women, SUI has been the result from ISD or a previously failed surgical repair, such as retropubic suspension or sling/tape techniques.

The ProACT™ devices consists of 2 adjustable balloon implants placed via perineal approach bilaterally in a periurethral position at the bladder neck or at the apex of the prostatic remnant. The implant procedure is minimally invasive and may be performed with general or local anesthesia in approximately 30 minutes. Titanium ports attached via tubing to each balloon are placed in the scrotum, allowing for transcutaneous, post-operative volume adjustment. Increasing the balloon volumes will increase the joining balloon pressure of the urethra, lifting the bladder neck. This lift will improve continence. Further adjustments can be made to meet the needs of the patient. The ACT™ devices essentially is placed the same way as the ProACT™ devices with 2 differences: 1) Balloons are placed only at the bladder neck; and, 2) The titanium ports are located in the labia majora. Each device system has 2 sizes, 1) ProACT™ - 12 cm and 14 cm; and 2) ACT™ - 8 cm and 9 cm.

Regulatory Status

Uromedica, Inc. (Plymouth, MN) has developed long-term implantable balloon therapy systems to treat male and female SUI. ProACT™ was approved by the U.S. Food and Drug Administration (FDA) premarket approval process on November 24, 2015. However, the ACT™ has not been approved by the FDA. Both device systems are available outside of the U.S.

FDA Product Code: EZY.

Rationale:

The policy originated in 2017 and was based on a literature search of Medline database through June 6, 2017. The following is a summary of the key literature to date.

In reviewing the evidence for ProACT™ and ACT™, it is important to note that most of the studies were case series with outcome measurements by the reduction of pads per day (PPD) use and quality of life (QoL) assessments from patients to determine continence improvement and satisfaction.

ProACT™

Case Series

Several case series were identified during the literature review. Significant improvements were measured in PPD, which generally meant most patients used a precautionary/safety absorbant pad daily. Table 1 shows the outcomes measurements following ProACT™ implantation.

Table 1. Efficacy Outcomes Following ProACT™ Implantation

Study

No. of Pts

Follow Up Time

Continence Achieved % (PPD Count)

Significantly Improved %

No Improvement %

Quality of Life Measurement

Hübner, et al. 2005 (6)

117

24 mons

67%

(baseline 6 PPD to 1 PPD at 2 yrs post operatively)

92%

8%

At baseline, 34.7 to 66.3 after 2 yrs

Kocjancic, et al. 2007 (7)

64

12 mons

66%

(42 pts)

(baseline 5.2 PPD to 1.54 PPD at 12 mons)

15%

(10 pts)

17%

(11 pts)

At baseline, 31.7 to 62.5 at 6 mons, and 71.1 at 12 mons)

Lebret, et al. 2008 (8)

62

12 mons

30%

(baseline 4.6 PPD to 1.06 PPD at 12 mons)

59%

83%

N/R

Trigo-Rocha, et al. 2006 (9)

23

4 yrs

65.2%

(15 pts)

13%

(3 pts)

22%

(5 pts)

N/R

Table Key:

Pts: patients;

No: number;

PPD: pads per day;

yrs; years;

mons: months;

N/R: not reported.

Comparative Studies

Two comparative studies have been published. One study compared the improvements in technique and evolution of expertise in using the ProACT™ system. The second comparative study evaluated ProACT™ to another surgical technique to address male stress urinary incontinence (SUI) following prostate surgery.

Hübner et al. in 2007 completed a comparative study of ProACT™’s original 50 patients (group 1) to the most recent 50 patients (group 2), comparing changes in pad use and incontinence QoL. (10) The mean follow up for group 1 was 23 months and group 2 was 20 months. Overall, group 2 patients obtained more consistent outcomes compared to group 1 (80% versus 60% dry or greater than 50% improved). The authors reported operative time was reduced in group 2 as were the rate and range of complications.

The second comparative study was published in 2008 by Crivellaro et al. (11) The comparison was between ProACT™ and a bone anchored male sling (BAMS) surgical treatment. A total of 84 patients participated in the study following post radical prostatectomy incontinence, with 46 having the ProACT™ system implanted or 38 having BAMS completed. At a mean follow up of 19 and 33 respectively, 30/44 (68%) patients treated with ProACT™ were dry (0/1 safety pad) in comparison with 23/36 (64%) patients treated with BAMS. Further stratifying the results, ProACT™ had 33/39 (85%) dry patients in severe (greater than 3 PPD) preoperative incontinence whereas BAMS had 21/26 (81%) dry patients in severe preoperative incontinence. The authors concluded when comparing ProACT™ to another surgical treatment for incontinence, the ProACT™ results seem to be the better choice for severe incontinence.

Systematic Reviews

There were no systematic reviews identified that would influence this review.

ECRI

There were no published ECRI reports identified during this review.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 2.

Table 2. Summary of Key Trials

NCT Number

Title

Planned Enrollment

Completion Date

Unpublished

NCT00277095a

ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males (ProACT)

123

Dec 2016

Table Key:

NCT: National Clinical Trial;

a: denotes an industry sponsored clinical trial.

Professional Guidelines and Position Statements

There are no professional guidelines and position statements that would likely influence this review.

ACT™

Case Series

As with ProACT™, ACT™ improvement outcomes were measured by PPD or pad weights. Table 3 shows those outcome measurements following ACT™ implantation.

Table 3. Efficacy Outcomes Following ACT™ Implantation

Study

No. of Pts

Follow Up Time

Continence Achieved % (PPD Count or Pad Weight)

Significantly Improved %

No Improvement %

Quality of Life Measurement

Kocjancic, et al. 2008 (12)

49

12 mons

68%

16%

N/R

N/R

Kocjancic, et al. 2010 (13)

57

6 yrs

51%

(29 pts)

(baseline 5.6 PPD to 0.41 PPD at 12 mons)

N/R

N/R

At 12 mons, 64% very much improved, 23% much improved, and 13% minimally improved

Aboseif, et al. 2009 (14)

140

12 mons

52%

dry at 12 mons

80%

N/R

At baseline, 36.5 to 70.7 at 12 mons

Wachter, et al. 2008 (15)

41

25 mons

44%

15% (29% had slight improvement)

12%

N/R

Aboseif, et al. 2011 (16)

77

12 mons

47%

(baseline 4.3 PPD to 1.9 PPD at 12 mons)

92%

N/R

At baseline, 33.9 to 71.6 at 12 mons

Table Key:

Pts: patients;

No: number;

PPD: pads per day;

yrs; years;

mons: months;

N/R: not reported.

Comparative Studies

There were no comparative studies identified that would influence this review.

Systematic Reviews

Two systematic reviews were published. ACT™ implantation, along with other types of surgical treatments, was included in a systematic review published in 2015 by Nikolopoulos et al. (17) The studies reviewed had five or more cases each from a period covering 1980-2017. Table 4 lists the different procedures with pooled success rates.

Table 4. Pooled Success Rates Reviewed for Surgical Interventions to Treat SUI

Surgical Intervention

Pooled Success Rate

(95% Confidence Interval)

Colposuspension

76% (±5.04)

Midurethral sling

68.5% (±3.11)

Repeat midurethral sling

66.2% (±4)

Midurethral sling fixation

61% (±10.56)

Pubovaginal sling

79.3% (±6.54)

Adjustable continence therapy AND adjustable slings

53.8% (±5.28)

Urethral bulking injections

38% (±10.7)

Laparoscopic 2-sling, salvage spiral sling, and artificial urinary sphincter procedures

Promising results, but data is limited

Reviewing the success rates, the use of ACT™ implantation appears to have a lower success rate than other more routinely utilized procedures.

An industry sponsored systematic review was published in 2014 by Phé et al. (18) This review targeted the ACT™ implantation surgical technique and the results of implantation for treatment of SUI. Eight studies were published between 2007 to 2013. The mean follow up of the studies were 1-6 years. Forty to 100% of the patients had already been treated surgically for SUI. A reduction of PPD were noted in each study following ACT™ implantation. More importantly, the QoL scores improved following implantation. The authors concluded ACT™ implantation was a reasonable treatment for SUI. However, long-term studies need to be analyzed.

ECRI

There were no published ECRI reports identified during this review.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 5.

Table 5. Summary of Key Trials

NCT Number

Title

Planned Enrollment

Completion Date

Ongoing

NCT02490917

ACT™ Balloons versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence (SU-ACT)

300

Dec 2019

Unpublished

NCT00113555a

Adjustable Continence Therapy (ACT) Device for the Treatment Female Stress Urinary Incontinence

221

Nov 2010 (completed)

Table Key:

NCT: National Clinical Trial;

a: denotes an industry sponsored clinical trial.

Professional Guidelines and Position Statements

There are no professional guidelines and position statements that would likely influence this review.

Summary of Evidence

The evidence is insufficient to support the use of the adjustable continence therapy ProACT™ system for adult men to treat stress urinary stress incontinence (SUI) arising from intrinsic sphincter deficiency (ISD). This is based on the several small cases series and small comparative studies. Although quality of life (QoL) responses from patients are encouraging and the pads per day (PPD) use diminishes following the implantation, further long-term studies are needed to show durability beyond 2 to 4 years. Therefore, the use of ProACT™ system to treat men is considered experimental, investigational and/or unproven.

The evidence is insufficient to support the use of the adjustable continence therapy ACT™ system for adult women to treat SUI arising from ISD. This is based on the several small cases series and lack of U.S. Food and Drug Administration approval for use in the U.S. As with ProACT™, QoL responses from patients are positive and the PPD count does decrease, further long-term studies are needed to show durability beyond 6 years. Therefore, the use of ACT™ system to treat women is considered experimental, investigational and/or unproven.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

None

HCPCS Codes

C9746

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Nitti VW. The prevalence of urinary incontinence. Rev Urol. 2001; 3(suppl1):S2-S6. PMID 16985992

2. Urology Care Foundation – What is urinary incontinence? The Official Foundation of the American Urological Association. Available at: <http://urologyhealth.org> (accessed on June 5, 2017).

3. Vasavada SP. Urinary incontinence (November 28, 2016). Medscape. Available at: <http://emedicine.medscape.com> (accessed on June 5, 2017).

4. FDA - ProACT™ Adjustable Continence Therapy for Men. Summary of Safety and Effectiveness Data (SSED) (November 24, 2015). U.S. Food and Drug Administration. Available at: <http://www.fda.gov> (accessed on June 1, 2017).

5. ProACT™ and ACT™. Product Information. Uromedica, Inc., Plymouth, MN. Available at <http://www.uromedica-inc.com> (accessed on June 6, 2017).

6. Hübner WA, Schlarp OM. Treatment of incontinence after prostatectomy using a new minimally invasive device: adjustable continence therapy. BJU Int. Sep 2005; 96(4):587-94. PMID 16104915

7. Kocjancic E, Crivellaro S, Ranzoni S, et al. Adjustable continence therapy for the treatment of male stress urinary incontinence: a single center study. Scand J Urol Nephrol. 2007; 41(4):324-8. PMID 17763225

8. Lebret T, Cour F, Benchetrit J, et al. Treatment of postprostatectomy stress urinary incontinence using a minimally invasive adjustable continence balloon device, ProACT: results of a preliminary, multicenter, pilot study. Urology. Feb 2008; 71(2):256-60. PMID 18308096

9. Trigo-Rocha F, Comes CM, Pompeo AC, et al. Prospective study evaluating efficacy and safety of adjustable continence therapy (ProACT) for post radical prostatectomy urinary incontinence. Urology. May 2006; 67(5):965-9. PMID 16698356

10. Hübner WA, Schlarp OM. Adjustable continence therapy (ProACT): evolution of the surgical technique and comparison of the original 50 patients with the most recent 50 patients in a single center. Eur Urol. Sep 2007; 52(3):680-6. PMID 17097218

11. Crivellaro S, Singla A, Aggarwal N, et al. Adjustable continence therapy (ProACT) and bone anchored male sling: comparison of two new treatments of post prostatectomy incontinence. Int J Urol. Oct 2008; 15(10):910-4. PMID 18761534

12. Kocjancic E, Crivellaro S, Smith JJ, et al. Adjustable continence therapy for treatment of recurrent female urinary incontinence. J Endourol. Jul 2008; 22(7):1403-7. PMID 18613782

13. Kocjancic E, Crivellaro S, Ranzoni S, et al. Adjustable continence therapy for severe intrinsic deficiency and recurrent female stress urinary incontinence: long-term experience. J Urol. Sep 2010; 184(3):1017-21. PMID 20643464

14. Aboseif SR, Franke EI, Nash SD, et al. The adjustable continence therapy system for recurrent stress incontinence: 1-year results of the North American Clinical Study Group. J Urol. May 2009; 181(5):2187-91. PMID 19296967

15. Wachter J, Henning A, Roehlich M, et al. Adjustable continence therapy for female urinary incontinence: a minimally invasive option for difficult cases. Urol Int. 2008; 81(2):160-6. PMID 18758213

16. Aboseif SR, Sassani P, Franke EI, et al. Treatment of moderate to severe female stress incontinence with the adjustable continence therapy (ACT) device after failed surgical repair. World J Urol. Apr 2011; 29(2):249-53. PMID 20959993

17. Nikolopoulos KI, Betshart C, Doumouchtsis SK. The surgical management of recurrent stress urinary incontinence: a systematic review. Acta Obstet Gynecol Scand. Jun 2015; 94(6):568-76. PMID 25737292

18. Phé V, Nguyen K, Rouprêt M, et al. A systematic review of the treatment for female stress urinary incontinence by ACT™ balloon placement (Uromedica, Irvine, CA, USA). World J Urol. Apr 2014. 32(2):495-505. PMID 23783882

Policy History:

DateReason
6/15/2018 Reviewed. No changes.
7/1/2017 New medical document. Implanted adjustable continence therapy is considered experimental, investigational and/or unproven as a minimally invasive treatment for urinary incontinence in adult men or women.

Archived Document(s):

Title:Effective Date:End Date:
Implanted Adjustable Continence Therapy07-01-201706-14-2018
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