Medical Policy

 

Subject: Treatments for Urinary Incontinence
Document #: SURG.00010 Publish Date:    08/29/2018
Status: Revised Last Review Date:    07/26/2018

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, 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 controlled trials (RCTs). These trials have established the safety and efficacy of agents cleared by 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, another product, Contigen® Bard Collagen Implant, is no longer available.

A 2017 Cochrane systematic review by Kirchin and colleagues identified 14 RCTs of urethral injection of bulking agents.  Sample sizes ranged from 30 to 355 and all included at least one objective outcome measure such as pad weight reduction. Comparison interventions included placebo (1 trial), pelvic floor exercises (1 trial) other surgical techniques (2 trials), a different bulking agent (8 trials) and different injection sites using the same agent (2 trials).  Due to differences in study design, the investigators did not pool study findings. The authors concluded that the evidence base is insufficient to guide practice and is limited by lack of long-term data and variable outcome reporting.  They noted that data up to 12 months suggests that injection of bulking agents appears to be less effective but safer than open surgery.

Another recent systematic review included controlled and uncontrolled observational studies and focused on two agents, Bulkamid and Macroplastique (Siddiqui 2017).  (Bulkamid has not been cleared by the FDA).  The authors identified 26 studies examining these agents for the treatment of SUI.  The authors did not pool study findings but reported that objective success rates in individual studies ranged from 25.4% to 73.3%.  The most commonly reported adverse events in the 651 individuals treated with Macroplastique were urinary tract infections (9%), implantation site pain and acute urinary retention (9%).  This study did not report any comparative outcome data.

The 2017 joint guideline by the American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) recommended bulking agents as one of several options for patients considering surgery for stress urinary incontinence.

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.  A 2013 Cochrane review by Herbison and Dean identified 23 RCTs comparing weighted vaginal cones to a control condition in women with urinary incontinence.  The authors noted that all of the studies had small sample sizes, some had high drop-out rates and study quality was difficult to assess in many cases.  Most studies used a similar protocol in which individuals held the cones in place twice a day for 15 minutes.  Outcome measures varied widely.  A comparison of interest is the efficacy of vaginal cones plus pelvic floor muscle training (PFMT) alone.  Two trials addressed this comparison and neither found a significant benefit of the addition of vaginal cones.  Thirteen trials compared vaginal cones and PFMT.  In a pooled analysis of 4 trials, there was not a significant difference between groups in leakage episodes per day (mean difference [MD], 0.00, 95% confidence interval [CI], -0.20 to 0.20).  Similarly, a pooled analysis of 5 trials did not find a significant difference between groups in the proportion of individuals with improvement on the pad test (risk ratio [RR], 1.10, 95% CI: 0.82 to 1.49).  Four trials reported on subjective improvement of cure and this outcome significantly favored the vaginal cone group (RR, 1.01; 95% CI, 0.75 to 1.36).  The ability to conduct pooled analyses was limited by variability in control interventions and outcome measures and thus a relatively small number of studies were included in the meta-analyses.  In these meta-analyses, objective measures did not find a significant benefit of vaginal cones compared with PFMT.

In a small prospective study, Haddad and colleagues (2011 evaluated 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 SUI were treated and 21 women completed the 3-month 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%).  This study lacked a comparison group of women who did pelvic floor exercises without the use of vaginal cones.

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. Several uncontrolled studies have been published. 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 concluded 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)

A 2015 Cochrane review by Kang and colleagues identified a single RCT evaluating transurethral radiofrequency energy collagen micro-remodeling for treatment of stress urinary incontinence (SUI).  This trial, by Appell and colleagues (2006),  randomized 173 women with SUI to active (n=110) or sham (n=63) treatment and followed participants for 12 months.  Primary outcomes were leak point pressure (LPP) and score on the incontinence quality of life (I-QOL).  At 12 months, 136 of 173 participants (79%) were available for the analysis of LPP.  Individuals in the active treatment group had an increase in mean LPP of 13.2 cm H2O and those in the sham group had a decrease in mean LPP of 2 cm H2O.  The difference in LPP between groups was statistically significant, p=0.002.  A total of 142 participants (82%) provided data for the I-QOL outcome at 12 months.  The proportion of evaluable participants with at least a 10 point I-QOL improvement (considered clinically meaningful) was 48% in the active treatment arm and 44% in the sham arm.  The difference between groups did not differ significantly, p=0.70.  The study had mixed findings and was limited by a substantial drop-out rate and the uncertain clinical significance of the LPP measure.

In addition to the RCT, a prospective, single-arm study with 3 years of follow-up evaluated transurethral collagen denaturation (Renessa) in women with SUI caused by bladder outlet hypermobility. Objective measures included voiding diaries and in-office stress pad weight tests. Subjective measures included the I-QOL, Urogenital Distress Inventory (UDI-6), and Global Impression of Improvement (PGI-I) instruments. Of the 136 women who were treated, 75 (55%) were available for 12 month follow-up (Elser 2009). 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).  At the 18-month follow-up, data were available on 60 women (44%).  The study found incontinent episodes decreased whereas quality of life and participant satisfaction with the procedure increased (Elser 2010).

A total of 41 women (30%) completed the 3-year follow-up (Elser 2011). According to diary data available for 39 women, 24 (62%) reported at least a 50% reduction in leaks per day. The investigators also reported 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. 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 outcome measures. However, the majority of available studies 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. For example, Sacomani (2017) reported long-term outcomes in 121 consecutive individuals who underwent AUS implantation following prostatectomy. After a mean follow-up of 5.2 years, 106 men (88%) still had their AUS device and 82 of these (68%) reported being completely dry. 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 men with stress incontinence of at least 12 months’ duration following prostate surgery who did not respond to conservative therapy, “

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.

Background/Overview

Urinary voiding dysfunction includes 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 UI 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.

There are a variety of therapies used to treat urinary incontinence.  The least invasive approaches include behavioral techniques such as fluid management and bladder training, pelvic floor muscle exercises and scheduled toilet trips. Medications used to treat urinary incontinence include anticholinergics and mirabegron.  In addition, the following medical devices are potential treatment options:

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 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 800Urinary Control System, (American Medical Systems, Minnetonka, MN) obtained clearance from the FDA to treat urinary incontinence due to reduced outlet resistance following prostate surgery. 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

Peer Reviewed Publications:

  1. Appell RA, Juma S, Wells WG, et al. Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol Urodyn. 2006; 25(4):331-336.
  2. Buchsbaum GM, McConville J, Korni R, Duecy EE. Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18(3):263-265.
  3. Cespedes RD. Collagen injection or artificial sphincter for postprostatectomy incontinence: collagen. Urology. 2000; 55(1):5-7.
  4. Chartier Kastler E, Genevois S, Gamé X, et al. Treatment of neurogenic male urinary incontinence related to intrinsic sphincter insufficiency with an artificial urinary sphincter: a French retrospective multicenter study. BJU Int. 2011; 107(3):426-432.
  5. Chen TY, Ponsot Y, Carmel M, et al. Multi-center study of intraurethral valve-pump catheter in women with a hypocontractile or acontractile bladder. Eur Urol. 2005; 48(4):628-633.
  6. Davila GW. Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durability. Adv Urol. 2011; 176498.
  7. Elser DM, Mitchell GK, Miklos JR, et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study. J Minim Invasive Gynecol. 2009; 16(1):56-62.
  8. Elser DM, Mitchell GK, Miklos JR, et al. Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol Urodyn. 2010; 29(8):1424-1428.
  9. Elser DM, Mitchell GK, Miklos JR, et al. Nonsurgical transurethral radiofrequency collagen denaturation: results at three years after treatment. Adv Urol. 2011; 2011:872057.
  10. Haddad JM, Ribeiro RM, Bernardo WM, et al. Vaginal cone use in passive and active phases in patients with stress urinary incontinence. Clinics (Sao Paulo). 2011; 66(5):785-791.
  11. Imamoglu MA, Tuygun C, Bakirtas H, et al. The comparison of artificial urinary sphincter implantation and endourethral macroplastique injection for the treatment of post-prostatectomy incontinence. Eur Urol. 2005; 47(2):209-213.
  12. Islah M, Cho SY, Son H. The current role of the artificial urinary sphincter in male and female urinary incontinence. World J Mens Health. 2013; 31(1):21-30.
  13. Kim SP, Sarmast Z, Daignault S, et al. Long-term durability and functional outcomes among patients with artificial urinary sphincters: a 10-year retrospective review from the University of Michigan. J Urol. 2008; 179(5):1912-1916.
  14. Lenihan J. Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. Am J Obstet Gynecol. 2005; 192(6):1995-1998.
  15. Leone RMU, Alessandri F, Medica M, et al. Outpatient periurethral injections of polyacrylamide hydrogel for the treatment of female stress urinary incontinence: effectiveness and safety. Arch Gynecol Obstet. 2013; 288(1):131-137.
  16. MacDonald R, Fink HA, Huckabay C, et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. 2007; 100(1):76-81.
  17. Madjar S, Covington-Nichols C, Secrest CL. New periurethral bulking agent for stress urinary incontinence: modified technique and early results. J Urol. 2003; 170(6 Pt 1):2327-2329.
  18. Mayer RD, Dmochowski RR, Appell RA, et al. Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence. Urology. 2007; 69(5):876-880.
  19. Mouritsen L, Lose G, Moller-Bek K. Long-term follow-up after urethral injection with polyacrylamide hydrogel for female stress incontinence. Acta Obstet Gynecol Scand. 2014; 93(2):209-212.
  20. Petero VG Jr, Diokno AC. Comparison of the long-term outcomes between incontinent men and women treated with artificial urinary sphincter. J Urol. 2006; 175(2):605-609.
  21. Ross JW, Galen DI, Abbott K, et al. A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence. J Am Assoc Gynecol Laparosc. 2002; 9(4):493-499.
  22. Sacomani CAR, Zequi SC, Costa WHD, et al. Long-term results of the implantation of the AMS 800 artificial sphincter for post-prostatectomy incontinence: a single-center experience. Int Braz J Urol. 2018; 44(1):114-120.
  23. Shamliyan TA, Kane RL, Wyman J, Wilt TJ. Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med. 2008; 148(6):459-473.
  24. Siddiqui ZA, Abboudi H, Crawford R, Shah S. Intraurethral bulking agents for the management of female stress urinary incontinence: a systematic review. Int Urogynecol J. 2017; 28(9):1275-1284.
  25. Sokol ER, Karram MM, Dmochowski R. Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter trial. North American study. J Urol. 2014; 192(3):843-849.
  26. Tamanini JT, D’Ancona CA, Netto NR Jr. Macroplastique implantation system for female stress urinary incontinence: long-term follow-up. J Endourol. 2006; 20(12):1082-1086.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). Surgical Treatment of Stress Urinary Incontinence. 2017 update. Available at: http://www.auanet.org/guidelines/stress-urinary-incontinence-(sui)-new-(aua/sufu-guideline-2017).  Accessed on June 18, 2018.
  2. 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 18, 2018.
  3. Herbison P, Plevnik S, Mantle J. Weighted vaginal cones for urinary incontinence. Cochrane Database Syst Rev. 2015;(7):CD002114.
  4. Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2017;(7):CD003881.
  5. 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 18, 2018.
  6. 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 18, 2018.
  7. 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.  7. Accessed on June 18, 2018.
  8. 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 18, 2018.
  9. 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 on June 18, 2018.
  10. 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 18, 2018.
  11. 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 18, 2018.
  12. 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 18, 2018.
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 18, 2018.
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

07/26/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date”.  Administrative changes made to investigational and not medically necessary statement. Rationale, Background/Overview and References sections updated.

Revised

08/03/2017

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