Medical Policy
Subject: Treatments for Urinary Incontinence
Document #: SURG.00010 Current Effective Date:    09/27/2017
Status: Revised Last Review Date:    08/03/2017
Description/Scope

This document addresses the following treatments for urinary incontinence:

Note: Please see the following related document(s) for additional information:

Position Statement

Medically Necessary:

Injection of periurethral bulking agents is considered medically necessary when one or more of the following are met:

Implantation of an artificial urinary sphincter device is considered medically necessary in male adults following prostate surgery to treat urinary incontinence due to reduced outlet resistance (Intrinsic Sphincter Deficiency [ISD]) when the symptoms of incontinence have been refractory to at least 6 months of conservative medical treatment.*

*Note: Artificial urinary sphincter implantation is not considered first-line treatment of refractory incontinence in male adults following prostate surgery. Examples of first-line conservative medical treatment may include one or more of the following: behavioral therapy, pharmacologic treatments, and intermittent self-catheterization.

Not Medically Necessary:

Implantation of an artificial urinary sphincter device is considered not medically necessary for all other indications including, but not limited to:

Investigational and Not Medically Necessary:

The following services are considered investigational and not medically necessary:

Rationale

Periurethral Bulking Agents

Periurethral injections of bulking agents, such as cross-linked collagen (for example, Contigen® Bard Collagen Implant, C.R. Bard, Inc., Covington, GA), carbon-coated beads (for example, Durasphere™ Advanced Uroscience, Inc., St. Paul, MN), calcium hydroxylapatite (for example, Coaptite® BioForm Medical, Inc., San Mateo, CA) and polydimethylsiloxane (for example, Macroplastique® Uroplasty, Inc., Minneapolis, MN) have been studied in randomized trials that established adequate safety and efficacy and have obtained clearance from the U.S. Food and Drug Administration (FDA) for the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincteric deficiency. Notably in 2011, the manufacturer of Contigen ceased production, and this product is no longer available.

Vaginal Weight Training

Vaginal weight training is a behavioral therapy that employs weights during Kegel or pelvic floor exercises to strengthen pelvic floor muscles. The use of vaginal weights (cones) has not been shown to improve pelvic floor muscle strength more than Kegel exercises alone.

Haddad and colleagues (2011) conducted a prospective study to evaluate vaginal cone therapy in a passive phase (without voluntary contractions of the pelvic floor) and an active phase (with voluntary contractions). Twenty-four women with a clinical and urodynamic diagnosis of stress urinary incontinence were treated. Clinical complaints, functional evaluation of the pelvic floor, a pad test, and bladder neck mobility were analyzed for 3 months. Twenty-one women completed the study. Outcomes in the pad test favored the active phase as did pelvic floor evaluation and bladder neck mobility. Complete reversal of symptomatology was observed in 12 (57.1%) participants, and satisfaction was expressed by 19 (90.4%). The authors concluded that using vaginal cones in the passive phase with the inclusion of an active phase led to additional improvement in all of the study parameters evaluated in women with stress urinary incontinence. However, randomized studies are needed to confirm these results.

Transvaginal Radiofrequency Bladder Neck Suspension (SURx Transvaginal System® SURx, Inc., Livermore, California)

The minimal published literature regarding transvaginal radiofrequency bladder neck suspension is inadequate to permit scientific conclusions regarding the safety and long-term efficacy of these procedures. Dmochowski and colleagues (2003) reported on a multi-institutional prospective case series of 120 consecutive women with urinary stress incontinence who underwent transvaginal bladder neck suspension. Enrolled subjects had failed at least a 3-month trial of conservative therapy, including, most commonly, pelvic floor muscle exercises or pelvic floor stimulation. Follow-up examinations at 1, 3, 6 and 12 months consisted of a history, physical examination and urodynamic studies. In addition, each participant completed a voiding diary and quality of life questionnaire. A cure was defined as a negative Valsalva maneuver; improvement was defined as decreased daily episodes or pad use. A total of 73% of the participants were considered cured or improved at 12 months. More than 68% of the participants reported satisfaction with the treatment. The authors conclude that the results are encouraging and that a 73% 12-month success rate suggests that this procedure has applicability for women with refractory incontinence who do not wish to undergo a more complicated surgical procedure. Ross and colleagues (2002) conducted a multicenter, prospective single-arm study that included 94 women with stress incontinence. At 1 year, the objective cure rate was 79% based on a negative leak point pressure. Assessment of quality of life was also significantly improved. Larger controlled studies with longer follow-up are needed to further evaluate this procedure.

Transurethral Radiofrequency Energy Collagen Micro-Remodeling (Renessa® System Novasys Medical, Inc., Newark, CA)

Transurethral radiofrequency energy collagen micro-remodeling is being investigated as a non-surgical treatment for women with stress urinary incontinence (SUI). Elser and colleagues (2009) reported 12-month results from an ongoing prospective, 36-month, open-label, single-arm clinical trial to assess efficacy of nonsurgical transurethral collagen denaturation (Renessa) in women with SUI caused by bladder outlet hypermobility. Objective metrics included voiding diaries and in-office stress pad weight tests. Subjective measures included the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Global Impression of Improvement (PGI-I) instruments. Of the 136 women who were treated, 75 were available for 12 month follow-up. At 12 months, significant reductions existed from baseline in the median number of daily (-0.61) and weekly (-4.0) leaks caused by activity, and 50% of the subjects experienced at least 50% fewer leaks compared with baseline (52% of evaluable participants). This study was limited by the large losses to follow-up.

Elser and colleagues (2010) also reported data at 18 months for this 3-year ongoing study. At this time, of the 136 women initially treated, clinical data for 60 were available. The data showed that incontinent episodes decreased while quality of life and participant satisfaction with the procedure increased. The authors noted, of all participants lost to follow up, 21 withdrew because of suboptimal results and from this group, 19 went on to have surgery. The authors stated that, since this was a single arm observational study, the lack of predefined response criteria permitted subjective bias in the participant's perception and expectations for outcomes. Furthermore, it cannot be assumed that the attrition was due to dissatisfaction; some women may have discontinued because they were doing well and did not wish to remain in the study. The authors concluded that while transurethral collagen denaturation is a nonsurgical option for SUI, it does not eliminate the need for subsequent surgery and further study is needed.

In 2011, Elser reported 3-year outcomes of this ongoing study. In an intention-to-treat (ITT) analysis of data from all 136 participants (last observation carried forward), 46.7% reported at least a 50% reduction in leaks from baseline. At 3 years, a total of 41 women (30% of the study population) completed the follow-up evaluation. According to diary data available for 39 women, 24 (62%) reported at least a 50% reduction in leaks per day. Based on the ITT analysis with multiple imputations of missing data, 60% of women had at least a 50% reduction in leaks. This study was limited by a large loss to follow-up and a lack of a control or comparison group.

Artificial Urinary Sphincter (AUS) Devices

Published studies of the AUS device have been limited by small numbers of trial subjects and variable values with which to determine success. However, the majority of available evidence has demonstrated significant improvements in the severity of incontinence and perceived quality of life scores from the use of AUS in male adults with refractory urinary incontinence due to ISD following prostate surgery. Investigators have noted high complication rates, (for example, infection, erosion, mechanical failure and device explantation) and need for reoperative procedures in up to 20% of implanted individuals (Imamoglu, 2005; Kim, 2008). For these reasons, AUS is not considered a first-line therapy and is reserved for those who have not responded to conventional treatment options for at least 6 months following prostate surgery. While post-prostatectomy incontinence is the main indication for AUS implantation, there is an increasing trend toward use of AUS for other indications including female and pediatric urinary incontinence due to ISD, congenital disorders, and neurological conditions. To date, the evidence from well-designed studies is insufficient to form conclusions regarding the safety and efficacy of AUS for other subgroups, such as women and children with intractable incontinence and in males who have not undergone prostate surgery (Islah, 2013).

inFlow Intraurethral Valve-Pump and Activator

At this time, there is only a single published peer-reviewed article describing the use of the inFlow intraurethral valve-pump, which received clearance through the FDA's de novo approval process in 2014. This prospective, single-arm crossover study by Chen in 2005 involved 273 subjects with hypocontractile or acontractile bladder conditions. The first 88 subjects were enrolled directly into the study phase involving an 8-week baseline phase using clean intermittent catheterization (CIC), followed by a 16-week inFlow treatment phase, and a final 4-week treatment withdrawal phase. Subsequent subjects were first enrolled in a 1-week tolerability trial (n=185). Those subjects that satisfactorily passed that phase (n=139) continued to the study phase. A total of 196 of the original 273 (72%) subjects withdrew from the study. These withdrawals were attributed to initial discomfort and leakage of the device. A total of 77 subjects completed the inFlow treatment phase. Post-void residual volume was comparable during baseline CIC phase and inFlow treatment phase (20.3 ml vs. 16.1 ml), with significantly improved quality of life (p<0.001). The published evidence currently available indicates that the inFlow device shows some promise for female individuals with incomplete bladder emptying, due to impaired detrusor contractility of neurologic origin, but larger more rigorous trials are needed to fully evaluate its safety and efficacy.

ProACT Adjustable Continence Therapy for Men

The ProACT System (Uromedica, Inc. Plymouth, MN) is an implantable, volume-adjustable balloon device which is connected to bi-lumen tubing that terminates in a subcutaneous injection port. The ProACT was approved by the FDA in November 2015 via a premarket approval (PMA) application for, "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." The FDA clearance was based on results of a prospective, multi-center, single-arm, open-label clinical study of 123 subjects in the intent-to-treat cohort. Subjects were followed for a minimum of 18 months following implantation with continued follow-up planned. The study was based on the primary and secondary endpoints at 18 months post-implant. The primary effectiveness endpoint was based on the average of two 24-hour pad weight measurements conducted at baseline and compared to the average of two 24-hour pad weight measurements conducted at 18 months. Individual success was defined as ≥ 50% reduction in 24-hour pad weight at 18 months, compared to baseline. Overall study success criteria was defined as an exact 95% binomial confidence interval lower boundary of ≥ 50% success at 18 months. The success rate, which was based on the primary endpoint, varied significantly across study sites and was reported as 46% (57/124) (95% confidence interval [CI], 37% to 55%), which did not meet the performance goal because the lower bound of the 95% CI was 37%, which is below the target responder rate of 50%. It was concluded that the study's primary effectiveness endpoint was not met. Secondary efficacy endpoints measured in this study included improvement in incontinence episodes per day, improvement in number of pads used per day, improvement in incontinence quality of life measure (I-QOL), improvement in UCLA-PCI urinary function scale, and impact on sexual functioning (International Index of Erectile Function). None of these secondary endpoints required further exploration since the study did not meet the primary endpoint. The study protocol's pre-specified approach for defining success (≥ 50% reduction in 24-hour pad weight) does not necessarily correlate well with the endpoints used in prior studies to assess the efficacy of the artificial urinary sphincter or male suburethral slings. Post hoc responder analysis was conducted utilizing a different endpoint based on a clinically meaningful change in 24-hour pad weight. This endpoint assessed how many subjects with greater than 100 gm baseline pad weight achieved an 18 month pad weight of < 30 gm. There were 86 subjects in the intent-to-treat cohort (69%) that had a baseline pad weight of greater than 100 gm. The success rate at 18 months using this endpoint was 24 out of 86 subjects (28%). It was noted that this study was limited by confounding factors, including missing data and the fact that 30 trial subjects underwent explantation of the ProACT device one or more times during the 18-month trial period, and more than half the subjects (75 of 123) underwent explant of the device after the 18-month assessment period. Additional study is needed to confirm the safety and efficacy of the ProACT system, as well as the most appropriate subject selection and the durability of any therapeutic effect.

Background/Overview

Urinary voiding dysfunction is divided into two general categories - urinary incontinence (UI) which is the inability to hold urine in the bladder and urinary retention, which is the inability to pass urine out of the bladder. Both men and women can experience urinary voiding dysfunction. Many women experience some incontinence due to pregnancy and childbirth, menopause, and the structure of the female urinary tract. Urinary retention in women can be caused by bladder muscle failure or obstruction. Many men experience incontinence and retention along with prostate enlargement or after prostate surgery.

Periurethral bulking agents refer to a variety of materials (collagen, carbon coated beads, calcium hydroxylapatite or polydimethylsiloxane) that may be injected around the urethra to provide better bladder control.

Vaginal weight training involves the use of small, specially designed weights ("cones") that a woman may place in the vagina and hold there, to strengthen the muscles in the pelvic area. Over time, increasingly heavier weights are used and this is thought to increase muscle strength. The vaginal cones are made from surgical grade stainless steel surrounded by a double welded plastic case. They are smooth with a plastic coated retrieval cord.

The SURx Transvaginal System, which obtained FDA clearance in March 2002, is a radiofrequency device that has been specifically designed as a transvaginal treatment of urinary stress incontinence that can be performed as an outpatient procedure under general anesthesia. An incision is made through the vagina lateral to the urethra, exposing the endopelvic fascia. Radiofrequency energy is then applied over the endopelvic fascia in a slow sweeping manner, resulting in blanching and shrinkage of the tissue. As of 2006, the SURx device is no longer marketed in the U.S.

Transurethral radiofrequency energy collagen micro-remodeling is a non-surgical treatment for women with SUI. Radiofrequency energy is used to apply controlled heat to targeted tissues in the lower urinary tract. The heat denatures submucosal collagen in the tissue at the treatment sites. After healing, the tissue is reported to be firmer and have increased resistance to involuntary leakage at times of increased intra-abdominal pressure, thus reducing or eliminating SUI episodes. The Renessa System, marketed by Novasys Medical, Inc. (Newark, CA) obtained FDA clearance as substantially equivalent to prior predicate devices and is indicated, "For the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy" (FDA, 2005).

The artificial urinary sphincter (AUS) is an externally controlled urethral occlusion device. The transfer of fluid within the device is controlled by a pressure-regulating balloon placed extraperitoneally in the individual's pelvis or abdominal cavity and a control pump placed in a subcutaneous pocket in the scrotum. Squeezing of the pump allows fluid within the closed-loop system to be transferred from the cuff to the balloon. It takes a few minutes before the cuff re-inflates automatically to the preset level, allowing the urethra to remain open for voiding. The valve then automatically re-tightens several minutes later which closes the urethra, thereby enabling control of urine flow and continence to be achieved.

In 2001, the AMS Sphincter 800™ Urinary Control System, (American Medical Systems, Minnetonka, MN) obtained clearance from the FDA to treat urinary incontinence due to reduced outlet resistance (Intrinsic Sphincter Deficiency [ISD]) following prostate surgery. This FDA clearance was based on the results of three clinical studies of male subjects with confirmed urinary incontinence who were at least 6 months post-prostate surgery; all three studies were conducted by the manufacturer, American Medical Systems. According to the FDA analysis of these studies, the following is excerpted:

Although the risks are not insignificant, the benefits of AMS Sphincter 800™ Urinary Prosthesis outweigh these risks for the intended use of treating urinary incontinence due to intrinsic sphincter deficiency following prostate surgery. The most important factors to be considered are:
1)  The device is not the first choice but the last choice for the patients who have severe incontinence resulting from prostate surgery and
2)  There is no other artificial sphincter device available in the market for these patients (this was true at the time [2001]; additional AUS devices have now become available).

CONCLUSION:
The literature and the studies referenced in this PMA (premarket approval) indicate that 65-70% of the patients achieve dryness, 90% of the patients achieve reasonable improvement in their incontinence (up to 3 pads/day) and 90-95% of the patients expressed satisfaction with the device because it improved the quality of their lives (FDA, 2001).

The AUS is contraindicated in individuals with repetitive urinary infections; urethral diverticula at the expected implant site; in complex, unstable, or recurrent urethral stricture disease; in small capacity and/or non-compliant bladder prior to definitive treatment; in irreversibly obstructed urinary tracts; in irresolvable detrusor hyperreflexia or bladder instability; or in those who lack the physical and/or mental dexterity to manipulate the pump.

The inFlow intraurethral valve-pump and activator is a urinary device for women with incomplete bladder emptying, due to impaired detrusor contractility (IDC). The inFlow is promoted as an alternative to urinary catheters. The device consists of a small catheter with an internal, magnetically-activated pump-valve mechanism which is placed in the female urethra for up to 29 days or less. Upon activation by a battery-powered wand held low over the pubic area, the valve opens and the pump induces urine flow. The device blocks urine flow when continence is desired, and an internal pump draws urine out of the bladder when activated by the user. Proper device sizing and initial insertion is done by a physician. Subsequent device replacements are self-inserted, or inserted by a caregiver, approximately every 29 days. This device obtained FDA clearance through the de novo approval process in 2014 and is indicated for, "Use in female individuals 18 years of age or older who have incomplete bladder emptying, due to impaired detrusor contractility of neurologic origin, and who are capable of operating it in accordance with instructions or who have trained caregivers" (FDA, 2014).

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 subjects) 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; 1 ml can be titrated monthly until optimum continence is achieved.

Definitions

Bulking agent: Refers to a substance, such as collagen, which is injected near the urinary opening to help increase pressure at the opening and prevent involuntary loss of urine.

Detrusor instability: A bladder that contracts and empties out urine even though it is not full, or when the person does not intend to urinate.

Intrinsic sphincter deficiency (ISD): A poor or non-functioning urethral outlet muscle.

Mixed incontinence: A combination of urge and stress incontinence.

Overflow incontinence: The bladder overfills without causing a sensation to urinate.

Periurethral: Around the urethra.

Stress urinary incontinence (SUI): The leakage of urine during physical activities that increase pressure on the bladder.

Urethra: The natural channel or tube through which urine passes from the bladder to outside of the body.

Urinary urge incontinence: Leakage of urine when there is a strong urge to void.

Urinary urgency-frequency: An uncontrollable urge to urinate resulting in very frequent, small volumes.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Injection of Periurethral Bulking Agents
When services may be Medically Necessary when criteria are met:

CPT  
51715 Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck
   
ICD-10 Procedure  
0TUC8JZ Supplement bladder neck with synthetic substitute, via natural or artificial opening endoscopic
0TUD8JZ Supplement urethra with synthetic substitute, via natural or artificial opening endoscopic
3E0K3GC Introduction of other therapeutic substance into genitourinary tract, percutaneous approach [when specified as injection of bulking agent]
3E0K8GC Introduction of other therapeutic substance into genitourinary tract, via natural or artificial opening endoscopic [when specified as injection of bulking agent]
   
ICD-10 Diagnosis  
N36.41-N36.44 Urethral functional and muscular disorders (hypermobility of urethra, ISD)
N39.3 Stress incontinence (female) (male)
N39.46 Mixed incontinence (urge and stress incontinence)
N99.89 Other postprocedural complications and disorders of genitourinary system
S37.20XA-S37.29XS Injury of bladder
S37.30XA-S37.39XS Injury of urethra

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Artificial Urinary Sphincter
When services may be Medically Necessary when criteria are met for males:

CPT  
53445 Insertion of inflatable urethral/bladder neck sphincter, including placement of pump, reservoir, and cuff
53446 Removal of inflatable urethral/bladder neck sphincter, including pump, reservoir, and cuff
53447 Removal and replacement of inflatable urethral/bladder neck sphincter including pump, reservoir, and cuff at the same operative session
53448 Removal and replacement of inflatable urethral/bladder neck sphincter including pump, reservoir, and cuff through an infected field at the same operative session including irrigation and debridement of infected tissue
53449 Repair of inflatable urethral/bladder neck sphincter including pump, reservoir, and cuff
   
HCPCS  
C1815 Prosthesis, urinary sphincter (implantable)
   
ICD-10 Procedure  
0THC0LZ-0THC8LZ Insertion of artificial sphincter into bladder neck [by approach; includes codes 0THC0LZ, 0THC3LZ, 0THC4LZ, 0THC7LZ, 0THC8LZ]
0THD0LZ-0THDXLZ Insertion of artificial sphincter into urethra [by approach; includes codes 0THD0LZ, 0THD3LZ, 0THD4LZ, 0THD7LZ, 0THD8LZ, 0THDXLZ]
   
ICD-10 Diagnosis  
N36.42 Intrinsic sphincter deficiency (ISD)
N39.3 Stress incontinence
N39.41-N39.498 Other specified urinary incontinence
N99.89 Other postprocedural complications and disorders of genitourinary system
R32 Unspecified urinary incontinence
T83.111A-T83.111S Breakdown (mechanical) of urinary sphincter implant
T83.121A-T83.121S Displacement of urinary sphincter implant
T83.191A-T83.191S Other mechanical complication of urinary sphincter implant

When services are Not Medically Necessary:
For the procedure codes listed above for females and children, when criteria are not met for males, for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as not medically necessary.

Other procedures and devices
When services are Investigational and Not Medically Necessary: 

CPT  
53860 Transurethral radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence
  No code for vaginal weight training
   
HCPCS  
A4335 Incontinence supply; miscellaneous [when specified as inFlow intraurethral valve-pump]
C9746 Transperineal implantation of permanent adjustable balloon continence device, with cystourethroscopy, when performed and/or fluoroscopy, when performed [ProACT system for men]
   
ICD-10 Diagnosis  
  All diagnoses
   
References

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  37. Weatherall M. Biofeedback or pelvic floor muscle exercises for female genuine stress incontinence: a meta-analysis of trials identified in a systematic review. BJU Int. 1999; 83(9):1015-1016.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and Quality (AHRQ). Shamliyan T, Wyman J, Kane RL. Nonsurgical treatments for urinary incontinence in adult women: diagnosis and comparative effectiveness. 2012. Available at: http://www.effectivehealthcare.ahrq.gov/ehc/products/169/834/CER36_UrinaryIncontinence_FinalReport_20120517.pdf. Accessed on June 21, 2017.
  2. American Urological Association (AUA). Guideline for the surgical management of female stress urinary incontinence: 2009 Update. Linthicum (MD): American Urological Association Education and Research, Inc; 2009. Available at: https://www.auanet.org/common/pdf/education/clinical-guidance/Incontinence.pdf . Accessed on June 21, 2017.
  3. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Incontinence control devices. NCD #230.10. Effective October 7, 1996. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=241&ncdver=1&DocID=230.10&bc=gAAAAAgAAAAAAA%3d%3d&. Accessed on June 21, 2017.
  4. Herbison P, Plevnik S, Mantle J. Weighted vaginal cones for urinary incontinence. Cochrane Database Syst Rev. 2002;(1):CD002114.
  5. Herschorn S, Bruschini H, Comiter C, et al.; Committee of the International Consultation on Incontinence. Surgical treatment of stress incontinence in men. Neurourol Urodyn. 2010; 29(1):179-190.
  6. Hunter KF, Glazener CM, Moore KN. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2007;(2):CD001843.
  7. Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2012;(2):CD003881.
  8. Pickard R, Reaper J, Wyness L, et al. Periurethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2003;(2):CD003881.
  9. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. Novasys Medical Transurethral Radiofrequency System. 510(k) Summary. No. K042132. Rockville, MD: FDA July 22, 2005. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K042132. Accessed on June 21, 2017.
  10. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. SurX RF System. 510(k) Summary. No. K020952. Rockville, MD: FDA. May 30, 2002. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K020952. Accessed on June 21, 2017.
  11. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness. Coaptite® . No. P040047. Rockville, MD: FDA. November 10, 2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040047b.pdf. Accessed on June 21, 2017.
  12. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). 510(k) Summary. Macroplastique® Implants. No. P040050. Rockville, MD: FDA. October 30, 2006. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P040050 . Accessed on June 21, 2017.
  13. U.S. Food and Drug Administration (FDA). 510(k) Summary of Safety and Effectiveness. Durasphere™ Injectable Bulking Agent. No. P980053. Rockville, MD: FDA. September 13, 1999. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_template.cfm?id=p980053 . Accessed June 21, 2017.
  14. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). 510(k) Summary of Safety and Effectiveness. AMS Sphincter 800™ Urinary Prosthesis. No. P000053. Rockville, MD: FDA. June 14, 2001. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_template.cfm?id=p000053 . Accessed on June 21, 2017.
  15. U.S. Food and Drug Administration (FDA). inFlow™ Intraurethral Valve-Pump approval. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/den130044.pdf. Accessed on June 21, 2017.
  16. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness. ProACT™ Adjustable Continence Therapy for Men. No. P130018. Rockville, MD: FDA. November 24, 2015. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130018B.pdf . Accessed on June 21, 2017.
Websites for Additional Information
  1. National Kidney and Urologic Diseases Information Clearinghouse. Urinary incontinence in women. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/uiwomen/index.htm. Accessed on June 21, 2017.
Index

AMS Sphincter 800
Artificial Urinary Sphincter, (AUS)
Coaptite
Durasphere
InFlow intraurethral valve-pump
Macroplastique
Periurethral Injection of Bulking Agents
ProACT System
Renessa
Transurethral Radiofrequency Energy Collagen Micro-Remodeling
Transvaginal Radiofrequency
Vaginal Weight Training

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
Revised 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Added the ProACT system to the investigational and not medically necessary listing. The Rationale, Background , Coding and References sections were updated.
Revised 02/02/2017 MPTAC review. Added inFlow intraurethral valve-pump to the investigational and not medically necessary section. Updated Rationale, Background, Coding and References sections. 
Reviewed 02/04/2016 MPTAC review. References were updated. Removed ICD-9 codes from Coding section.
Revised 02/05/2015 MPTAC review. Artificial urinary sphincter devices were added to the scope and position statements with medically necessary criteria and not medically necessary indications. The Rationale, Background, Coding, and References were updated.
Reviewed 08/14/2014 MPTAC review. References were updated.
Reviewed 08/08/2013 MPTAC review. Rationale and References updated.
Reviewed 08/09/2012 MPTAC review. Rationale and References updated.
Revised 08/18/2011 MPTAC review. Document revised to only address vaginal weight training, injection of periurethral bulking agents, transvaginal radiofrequency bladder neck suspension, and transurethral radiofrequency energy collagen micro-remodeling with no change to position statements. Revised title, updated Rationale, Background, Definition, Coding, and References sections. Sacral nerve stimulation and posterior tibial nerve stimulation addressed separately in SURG.00117.
Reviewed 02/17/2011 MPTAC review. Rationale and References updated.
  01/01/2011 Updated Coding section with 01/01/2011 CPT changes; removed 0193T deleted 12/31/2010.
Revised 02/25/2010

MPTAC review. Position statements revised:

  • to include children in the investigational and not medically necessary biofeedback statement;
  • to remove electrical stimulation, alone or in combination with other treatments.

Rationale, background, references, coding updated.

Revised 02/26/2009 MPTAC review. Removed Tegress® from document as it was discontinued by the manufacturer. Removed device brand names from position statement. Clarified position statement. Rationale, coding, background and references updated.
  01/01/2009 Updated coding section with 01/01/2009 CPT changes; removed 0029T deleted 12/31/2008.
Revised 02/21/2008 MPTAC review. Added language addressing repeat collagen injections. Clarified PTNS statement. Rationale, coding and references updated. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Revised 03/08/2007 MPTAC review. Coaptite and Macroplastique added as medically necessary with criteria.
Revised 12/07/2006 MPTAC review. Clarified peripheral nerve evaluation test and temporary sacral nerve stimulator. Added GYNECARE TVT SECUR System to Index. Noted name change of URYX® to Tegress™.
Revised 09/14/2006 MPTAC review. Added transurethral radiofrequency energy collagen micro-remodeling as INV/NMN. Coding updated; removed HCPCS E0752, E0754, E0756, E0757, E0758 deleted 12/31/2005.
Revised 06/08/2006 MPTAC review.
  01/01/2006 Updated coding section with 01/01/2006 CPT/HCPCS changes
  11/21/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised 07/14/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations Last Review Date Document Number Title
Anthem, Inc. 01/25/2004 SURG.00010 Urinary Incontinence Therapy, Adult (Including Sacral Nerve Stimulation)
WellPoint Health Networks, Inc. 06/24/2004 2.08.03 Biofeedback for the Treatment of Urinary Incontinence
  06/24/2004 2.08.07 Pelvic Floor Stimulation as a Treatment of Incontinence
  04/28/2005 2.08.08 Urethral Bulking Agents and Artificial Urinary Sphincters for the Treatment of Incontinence
  06/24/2004 2.08.09 Sacral Nerve Neuromodulation as a Treatment of Pelvic Floor Dysfunction
  09/23/2004 3.08.03 Radiofrequency Therapy as a Treatment of Urinary Incontinence