Medical Policy: 02.01.27
Original Effective Date: November 1995
Reviewed: June 2019
Revised: June 2019
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Urinary incontinence is defined as the involuntary loss of urine, or the inability to hold urine. It is a common condition affecting both geno typical men and geno typical women. There are several types, such as stress and urge incontinence, detrusor instability, etc. Many geno typical women experience this after childbirth and with increasing age due to muscle weakness. Many geno typical men experience this along with prostate problems.
There are different types of urinary incontinence. This includes stress incontinence, urge incontinence, mixed incontinence, overflow incontinence, functional incontinence, urinary retention, neurogenic bladder, urinary fistula, and psychogenic incontinence.
There are various treatment options available, such as conservative, surgical procedures and supportive devices. Examples of these various treatment options are listed below;
- Conservative: Includes medical treatment weight loss, fluid management, bladder training, pelvic floor rehabilitation, Kegel exercises and chronic catheterization. The American Urogynecologic Society recommends a minimum of three months conservative treatment.
- Surgical Procedures: Include, but are not limited to, periurethral bulking agents, augmentation cystoplasty, bladder denervation or detrusor myomectomy, enterocystoplasty, bladder diversion, artificial urinary sphincter and cystectomy. These may not be considered first line treatments for most patients and other conservative measures may be considered first.
- Other measures and supportive devices for the management of urinary incontinence: Include intermittent catheterization, indwelling urethral catheterization, suprapubic catheters, external collection systems, urethral insert devices (Attain), penile compression device, pelvic organ support devices, sling systems (MiniArcTM) and absorbant garments.
- Pelvic Floor Stimulation (PFS): This involves the electrical stimulation of the pelvic floor muscles using a probe wired to a device controlling the electrical stimulation, or more recently, extracorporeal pulsed magnetic innervation. It is believed that electric or magnetic stimulation leads to PFS, which in turn stimulates the pudendal nerve to improve urethral closure by activating the pelvic musculature by enhancing the process of re-innervation. PFS is an off-label use for electrical stimulation devices.
- Posterior tibial nerve stimulation (PTNS) The procedure for PTNS consists of the insertion of a needle above the medial malleolus into the posterior tibial nerve followed by the application of low voltage (10mA, 1-10 Hz frequency) electrical stimulation that produces sensory and motor responses (i.e., a tickling sensation and plantar flexion or fanning of all toes). Noninvasive PTNS has also been delivered with surface electrodes.
Artificial Urinary Sphincter
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.
The artificial urinary sphincter (AUS) is the gold standard of treatment for geno typical male urinary incontinence following prostate surgery. It has withstood the test of time, being unsurpassed by any other device for decades. The AUS is particularly effective for the more severe type of geno typical male urinary incontinence, where circumferential compression of the urethra is required.
Transvaginal and transurethral radiofrequency energy
The Renessa® procedure induces collagen denaturation in the urethra with a specially designed 4 needle radiofrequency probe. Transurethral treatment changes the collagen at microscopic sites targeted within the bladder neck and areas within the urethral submucosa. The low-level RF energy is believed to strengthen the sphincter without destroying the tissue, by heating only small areas around the probe tip to a specified temperature at which collagen begins the denaturation process.
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."
Adjustable Continence Therapy (The ACT, The ProACT)
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.
Guidelines and Position Statements
National Institute for Health and Care Excellence (NICE)
In 2013, the National Institute for Health and Care Excellence (NICE) amended its 2006 clinical guideline on urinary incontinence in women. The guideline now recommends considering intramural bulking agents (silicone, carbon-coated zirconium beads or hyaluronic acid/dextran copolymer) for the management of SUI if conservative management has failed. Women should be made aware that repeat injections may be needed to achieve efficacy and that efficacy diminishes with time and is inferior to that of synthetic tapes or autologous rectus fascial slings.
American College of Obstetricians and Gynecologists
In 2016, the American College of Obstetricians and Gynecologists issued an updated practice bulletin on urinary incontinence in women. The practice bulletin states that “urethral bulking injections are a relatively noninvasive treatment for stress urinary incontinence that may be appropriate if surgery has failed to achieve adequate symptom reduction, if symptoms recur after surgery, in women with symptoms who do not have urethral mobility, or in older women with comorbidities who cannot tolerate anesthesia or more invasive surgery. However, urethral bulking agents are less effective than surgical procedures such as sling placement and are rarely used as primary treatment for stress urinary incontinence.” There was insufficient evidence to recommend any specific bulking agent.
European Urology Association and European Urogynecological Association
In 2017, the European Urology Association and European Urogynecological Association issued a joint consensus review of data on implanted material for pelvic organ prolapse and stress urinary incontinence. They stated: “Urethral balloons and injectables are not recommended as first-line therapy for SUI. Bulking agents are associated with lower cure rates of SUI when compared with colposuspension or autologous fascial slings.
The 2017 joint guidelines on surgical treatment of female stress urinary incontinence from the American Urological Association and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction stated that bulking agents are an option for patients considering surgery for stress urinary incontinence (SUI). The guidelines also stated that there are few long-term data on the efficacy of bulking agents and that retreatment is common.
European Association of Urology
The latest version of the European Association of Urology clinical guidelines on the assessment and nonsurgical management of urinary incontinence was published in 2018 The following statements were made on electrical PFS and magnetic PFS:
“Do not offer electrical stimulation with surface electrodes (skin, vaginal, anal) alone for the treatment of stress urinary incontinence.” (strong recommendation)
Do not offer magnetic stimulation for the treatment of urinary incontinence or overactive bladder in women.” (strong recommendation)
For information on sacral nerve stimulation please see policy 08.01.21
The following urinary incontinence treatments and devices may be considered medically necessary when the following conditions have been met:
Periurethral bulking agents
Periurethral bulking agents using cross-linked collagen, carbon-coated spheres, calcium hydroxylapatite, or polydimethylsiloxane marketed under the trade names Durasphere®, Coaptite®, and Macroplastique® respectively, may be considered medically necessary when the following criteria have been met:
- The patient has been diagnosed with stress incontinence due to intrinsic sphincter weakness, or due to post traumatic or surgical injury, AND
- The patient has shown no improvement from at least 6 months of conservative measures (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy).
- If collagen implant (Contigen) is used, a skin test is performed about a month prior to the implant to ensure that no hypersensitivity exists
- The only FDA approved product for the use in men is Contigen
Up to five injection treatments may be considered medically necessary, beyond that, the patient would be considered a treatment failure and further treatment would be considered not medically necessary.
Bulking agents are not considered first line therapy. Conservative measures, including fluid management, smoking cessation, weight loss, vaginal exercises, and/or treatments of underlying causes of incontinence would be necessary for at least 6 months prior to the use of bulking agents.
The treatment of types of incontinence other than stress incontinence, with periurethral bulking agents is considered investigational.
Based upon literature, urethral bulking agents when used in the treatment of other types of urinary incontinence (e.g., urinary retention with overflow incontinence, functional incontinence, neurogenic bladder dysfunction, urinary fistulas and psychogenic incontinence), as yet, have not demonstrated a benefit to the patient.
Artificial Urinary Sphincter
Implantation of an artificial urinary sphincter device is considered medically necessary in geno typical 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 2 conventional conservative therapies for a minimum of 6 months (e.g., behavioral training such as bladder training, prompted voiding, or pelvic muscle exercise training, pharmacologic treatment for at least a sufficient duration to fully assess its efficacy).
Artificial urinary sphincter implantation is not considered first-line treatment of refractory incontinence in geno typical 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.
Implantation of an artificial urinary sphincter device is considered not medically necessary for all other indications including, but not limited to:
- Treatment of intrinsic sphincter deficiency in geno typical women and children whose incontinence has been refractory to conservative medical treatment or other surgical treatments; and
- Treatment of intrinsic sphincter deficiency in geno typical men who have not undergone prostate surgery.
Subureteric injection of dextranomer/hyaluronic acid copolymer (Deflux) Deflux® is a gel-like liquid containing complex sugars, packaged in a syringe. It is used to treat children who have vesicoureteral reflux, an abnormal condition in which urine flows backwards from the bladder to the kidneys.
Indications include treatment of children with vesicoureteral reflux (VUR) grades II-IV. All other indications are considered investigational.
The following treatments and devices are considered investigational for the treatment of urinary incontinence/urinary dysfunction:
- Biofeedback is considered investigational, since there is no evidence that this is more effective than pelvic muscle exercises, i.e. Kegel exercises.
- Vaginal weight training with specially designed weights (cones) is considered investigational.
- Pelvic floor stimulation by any method, electrical or magnetic, is considered investigational.
- Periurethral bulking agents other than those listed in the policy section above, including, but not limited to, Teflon®, autologous ear chondrocytes, autologous myoblast, and autologous fat tissue are all considered investigational.
- Transvaginal and transurethral radiofrequency energy therapies for bladder neck suspension, including, but not limited to, the Renessa® System, and the SURx Radiofrequency Bladder Neck Suspension System are all considered investigational.
- Posterior tibial nerve stimulation is considered investigational for all indications, including but not limited to: urinary frequency, urgency, incontinence, and retention in the treatment of urinary dysfunction.
- The Neocontrol system, which uses extracorporeal magnetic innervation (ExMI) is considered investigational because its effectiveness has not been established.
- Laser therapy (Genityte procedure) is considered investigational.
- Stem cell therapy for the treatment of urinary incontinence is considered investigational
- Transperineal Implantation of Permanent Adjustable Balloon Continence Device or Adjustable Continence Therapy (The ACT, ProACT) are considered investigational
- The inFlow™ intraurethral valve-pump implantation is considered investigational for all indications
- Visual Biofeedback and Guided Exercise Program (e.g. Attain) is considered investigational
Procedure Codes and Billing Guidelines:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 0548T Transperineal periurethral balloon continence device; bilateral placement, including cystoscopy and fluoroscopy
- 0549T Transperineal periurethral balloon continence device; unilateral placement, including cystoscopy and fluoroscopy
- 0550T Transperineal periurethral balloon continence device; removal, each balloon
- 0551T Transperineal periurethral balloon continence device; adjustment of balloon(s) fluid volume
- L8603 Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and necessary supplies
- L8604 Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, urinary tract, 1 ml, includes shipping and necessary supplies
- L8606 Injectable bulking agent, synthetic implant, urinary tract, 1 ml syringe, includes shipping and necessary supplies
- E0740 Non-implanted pelvic floor electrical stimulator, complete system
- E0746 Electromyography (EMG), biofeedback device
- 51715 Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck
- 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
- 53449 Repair of inflatable urethral/bladder neck sphincter including pump, reservoir, and cuff
- 53860 Transurethral, radiofrequency micro-remodeling of the female bladder neck and proximal urethra for stress urinary incontinence
- 64566 Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming
- 90911 Biofeedback training, perineal muscles, anorectal or urethral sphincter, including EMG and/or manometry
- 97039 Unlisted modality (specify type and time if constant attendance)
- 53899 Unlisted procedure, urinary system (specifically for ExMi)
- 58999 Unlisted procedure, female genital system (nonobstetrical)
- C1815 Prosthesis, urinary sphincter (implantable)
- 97014 Application of a modality to 1 or more areas; electrical stimulation (unattended)
- 97032 Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes
- E1399 Durable Medical Equipment, miscellaneous
- ECRI. Implantable Sacral Nerve Stimulator for Urinary Dysfunction. Plymouth Meeting (PA): ECRI Health Technology Information Service 2006 August 17. 8p. (ECRI Hotline Response).
- ECRI. Injectable Urethral Bulking Agents for the Treatment of Urinary Stress Incontinence. Plymouth Meeting (PA): ECRI Health Technology Information Service 2006 September 22. 11p. (ECRI Hotline Response).
- ECRI. Sling Systems for Female Urinary Stress Incontinence. Plymouth Meeting (PA): ECRI Health Technology Information Service 2006 October 25. 13p. (ECRI Hotline Response).
- ECRI. Nonsurgical, Transurethral Radiofrequency Collagen Denaturation for Female Stress Urinary Incontinence. Plymouth Meeting (PA):ECRI Health Technology Information Service 2007 August 10. 6p. (ECRI Hotline Response).
- Elser, DM, Mitchell, GK, Miklos, JR, Nickell, KG, Cline, K, Winkler, H, and Wells, WG. 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.
- Davila, GW. Nonsurgical outpatient therapies for the management of female stress urinary incontinence: long-term effectiveness and durability. Adv Urol. 2011;2011:176498.
- 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 Nov;29(8):1424-8.
- ECRI. Health Technology Information Service Nonsurgical, Transurethral Radiofrequency Collagen Denaturation for Female Stress Urinary Incontinence. Plymouth Meeting (PA). 2010 Aug 24. (ECRI Hotline Service)
- Lucas MG, Bosch RJ, Burkhard FC, et al. EAU Guidelines on Surgical Treatment of Urinary Incontinence. Eur Urol. 2012 Sep 17. [Epub ahead of print]
- Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinece in Adult Women: Diagnosis and Comparative Effectiveness. Pub. No. 11(12)-EHC074-EF. Rockville (MD): Agency for Healthcare Research and Quality (US). Comparative Effectiveness Review; April 2012.
- National Institute for Health and Clinical Excellence (NICE). Urinary incontinence in neurological disease. Clinical guideline 148; August 2012.
- Ghoniem GM & Miller CJ. A systematic review and meta-analysis of Macroplastique for treating female stress urinary incontinence. Int Urogynecol J. 2012 Jun 15. [Epub ahead of print]
- Pradhan A, Jain P, Latthe PM. Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2012 Jul;23(7):831-41.
- Monga AK, Tracey MR, Subbaroyan J. A systematic review of clinical studies of electrical stimulation for treatment of lower urinary tract dysfunction. Int Urogynecol J. 2012 Aug;23(8):993-1005.
- Greer JA, Smith AL, Arya LA. Pelvic floor muscle training for urgency urinary incontinence in women: a systematic review. Int Urogynecol J. 2012 Jun;23(6):687-97.
- Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. 2012 May. 36 p.
- Agency for Healthcare Research and Quality (AHRQ). Nonsurgical Treatments for Urinary Incontinece in Adult Women: Diagnosis and Comparative Effectiveness. Pub. No. 11(12)-EHC074-EF. Prepared by Minnesota Evidence-based Practice Center, Minneapolis MN; April 2012.
- ECRI. Posterior Tibial Nerve Stimulation for Treating Urge Incontinence. Plymouth Meeting (PA): ECRI Health Technology Information Service 3/20/12.[Hotling Response].
- Deflux-product insert Oceana Therapeutics. Accessed 9/16/13.
- Committee on Gynecologic Practice, guideline recommendation Nuber 603. June 2014.
- 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.
- 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.
- O'Connor RC, Nanigian DK, Patel BN, et al. Artificial urinary sphincter placement in elderly men. Urology. 2007 Jan; 69(1): 126-8.
- Sand, PK., Owens, GM., Black, EJ., Anderson, LH., Martinson, MS. Cost=effectiveness of radiofrequency microremodeling for stress urinary incontinence. Int Urogynecol. 2014; 25(4): 517-23.
- Lukban, JC. Transureethral radiofrequency collagen denaturation for treatment of female stress urinary incontinence: a review of the literature and clinical recommendations. Obstet Gynecol Int. 2012.
- Shamliyan T, Wyman J, Kane RL. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness. Comparative Effectiveness Review No. 36. (Prepared by the University of Minnesota Evidence-based Practice Center under Contract No. HHSA 290-2007-10064-I.) AHRQ Publication No. 11(12)-EHC074-EF. Rockville, MD. Agency for Healthcare Research and Quality. April 2012
- Moroni RM, Magnani PS, Haddad JM, et al. Conservative treatment of stress urinary incontinence: a systematic review with meta-analysis of randomized controlled trials. Rev Bras Ginecol Obstet. Feb 2016;38(2):97-111. PMID 26883864
- Hsu LF, Liao YM, Lai FC, et al. Beneficial effects of biofeedback-assisted pelvic floor muscle training in patients with urinary incontinence after radical prostatectomy: A systematic review and metaanalysis. Int J Nurs Stud. Aug 2016;60:99-111. PMID 27297372
- Starr,J., Drobnis, E., Lenger,S., Parrot, J., Barrier, B., Foster, R.,(2013). Outcomes of a comprehensive nonsurgical approach to pelvic floor rehabilitation for urinary symptoms, defecatory dysfunction, and pelvic pain. Female Pelvic Medicine and Reconstructive Surgery. 95, 260-264.
- 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.
- U.S. Food and Drug Administration (FDA). inFlow™ Intraurethral Valve-Pump approval.
- ECRI Institute. ProACT Adjustable Continence Therapy for Treating Male Stress Urinary Incontinence. May 2018
- Pergialiotis V, Prodromidou A, Perrea DN, Doumouchtsis SK. A systematic review on vaginal laser therapy for treating stress urinary incontinence: Do we have enough evidence? Int Urogynecol J. 2017;28(10):1445-1451.
- Rodrigues MP, Paiva LL, Ramos JGL, Ferla L. Vibratory perineal stimulation for the treatment of female stress urinary incontinence: A systematic review. Int Urogynecol J. 2017 Aug 15 [Epub ahead of print].
- Deegan EG, Stothers L, Kavanagh A, Macnab AJ. Quantification of pelvic floor muscle strength in female urinary incontinence: A systematic review and comparison of contemporary methodologies. Neurourol Urodyn. 2018;37(1):33-45.
- Song P, Wen Y, Huang C, et al. The efficacy and safety comparison of surgical treatments for stress urinary incontinence: A network meta-analysis. Neurourol Urodyn. 2018 Jan 13 Epub ahead of print].
- Chapple CR, Cruz F, Deffieux X, et al.(2017) Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. Apr 13 2017. PMID 28413126
- Kobashi KC, Albo ME, Dmochowski RR, et al.(2017) Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline. J Urol. Jun 15 2017. PMID 28625508
- Nambiar AK, Bosch R, Cruz F, et al.(2018) EAU guidelines on assessment and nonsurgical management of urinary incontinence. Eur Urol. Apr 2018;73(4):596-609. PMID 29398262
- Zhang J, Gao L, Liu M, Liu C. Effect of bariatric surgery on urinary incontinence in obese women: A meta-analysis and systematic review. Female Pelvic Med Reconstr Surg. 2018 Aug 31 [Epub ahead of print].
- Tutolo, Manuela et al. What Is New in Neuromodulation for Overactive Bladder? European Urology Focus, Volume 4, Issue 1, 49 - 53
- Nelson HD, Cantor A, Pappas M, Miller L. Screening for urinary incontinence in women: A systematic review for the women's preventive services initiative. Ann Intern Med. 2018;169(5):311-319.
- June 2019 - Annual review, Policy revised
- June 2018 - Annual review, Policy revised
- June 2017 - Annual review, Policy revised
- June 2016 - Annual review, Policy revised
- July 2015 - Annual review, Policy revised
- August 2014 - Annual review, Policy revised
- May 2014 - Policy review, Policy revised
- September 2013 - Annual review, Policy renewed
- October 2012 - Annual review, Policy renewed
- October 2011 - Annual review, Policy renewed
- September 2010 - Annual review, Policy renewed
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