Medical Policy: 02.01.27 

Original Effective Date: November 1995 

Reviewed: June 2021 

Revised: June 2021 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

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.

 

Description:

Urinary voiding dysfunction includes urinary incontinence (UI) which is the inability to hold urine urine in the bladder and urinary retention which is the inability to pass urine out of the bladder. Urinary incontinence (UI) is a common condition affecting both geno typical men and geno typical women. Many geno typical women experience UI due to pregnancy and childbirth, menopause and the structure of the female urinary tract. Many geno typical men experience incontinence along with prostate enlargement or after prostate surgery.

 

There are different types of urinary incontinence. This includes stress incontinence, urge incontinence/overactive bladder, mixed incontinence, overflow incontinence, functional incontinence, urinary retention, neurogenic bladder, and psychogenic incontinence.

 

There are various treatment options available, such as conservative therapy, surgical procedures and supportive devices for the treatment of urinary incontinence which may include the below:

  • Conservative Therapies: Include medical treatment or lifestyle changes: weight loss, dietary changes (some beverages my exacerbate symptoms, reduce consumption of alcoholic, caffeinated and carbonated beverages), bladder training, pelvic floor rehabilitation, Kegel exercises, vaginal weighted cones, biofeedback, topical vaginal estrogen and catheterization. The American Urogynecologic Society recommends a minimum of three months conservative therapy 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. Patients whose symptoms persist despite conservative therapies for a minimum of three months should have further surgical evaluation to discuss surgical options.
  • 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 (MiniArc) and absorbent 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 (AUS)

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 extra-peritoneally 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) has been shown to be effective for UI due to intrinsic urethral sphincter deficiency (IUSD) and is a useful alternative when conservative interventions have failed.  Implantation of an AUS is a commonly used surgical option for the management of male urethral deficiency especially, following prostatectomy.

 

Potential candidates for AUS implantation should be evaluated preoperatively to exclude severe detrusor instability as well as to ensure adequate bladder stability and compliance prior to implantation of the AUS.  Appropriate candidates for implantation of an AUS must have adequate motivation and sufficient manual dexterity to operate the device.  Post-prostatectomy patients should wait 6 to 12 months and attempt behavioral and pharmacologic therapies first. 

 

AUS may also be utilized in patients with epispadias-exstrophy in whom bladder neck reconstruction has failed; women in whom behavioral or pharmacologic therapies, or other surgical options have failed; and children with intractable UI who are refractory to pharmacologic therapies or unsuitable for other types of operation. 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 males who have not undergone prostate surgery.

 

Transvaginal and Transurethral Radiofrequency Energy

The Lyrette Transurethral SUI System: Previously known as Renessa Procedure, this procedure involves passing a specially designed 4-needle radiofrequency probe through the urethral opening into the urethra and then into the bladder. Once the probe is in position, a small balloon is inflated to keep it stationary during the procedure. Radiofrequency energy is then delivered for 60 seconds to the 4 needles, which are deployed from the probe into the tissue of the bladder neck and upper urethra. Tissue temperatures of 65 to 75 degrees Celsius are generated; at this temperature, focal microscopic denaturation of collagen occurs. The procedure is repeated 9 times so that collagen is denatured at 36 tissue sites.

 

The transvaginal radiofrequency bladder neck suspension SURx Transvaginal System involves making an incision 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.

 

Evidence from well-conducted, randomized, controlled trials on transvaginal and transurethral radiofrequency tissue remodeling for urinary stress incontinence remains limited in quantity and quality. It is not known whether either of these treatments leads to long-term improvements in net health outcomes compared with a sham procedure or another treatment for stress urinary incontinence; therefore, both transvaginal and transurethral radiofrequency tissue remodeling for urinary stress incontinence are considered investigational.

 

The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

inFlow Intraurethral Valve-Pump and Activator

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. 

 

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 versus 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.

 

The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

ProACT Adjustable Continence Therapy 

The ProACT adjustable continence 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. 

 

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 primary effectiveness endpoint was the average of two 24-hour pad weight measurements conducted at baseline 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, was 46% (57/124) (95% 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.

 

Several additional single-arm studies evaluating ProAct in men with SUI following prostate surgery have been published (Nestler, 2018; Noorhoff 2017, Ronzi, 2019). Complication rates and/or need for revision surgery tended to be high. In the Nestler (2018) study, 59 of 112 implants of the ProAct system (53%) had to be revised after a median of 26 months due to rupture or dislocation/migration. Ronzi and colleagues (2019) identified complications in 70 of 102 cases (69%) including 34 migrations, 18 device failures, 28 urethral erosions and 28 cutaneous erosions.

 

A systematic review of studies on ProAct in men with SUI was published in 2019 by Larson and colleagues. No RCTs were identified. The authors included 19 studies with a total of 1264 individuals. In a pooled analysis of data on ProAct treatment, 60.2% of individuals were ‘dry’ at follow-up and 81.9% were either ‘dry’ or ‘improved’. No data from any comparison intervention were reported. A pooled analysis of adverse event data from 18 studies found a 5.3% rate of intraoperative bladder or urethra perforation and a 22.2% revision rate over a mean follow-up of 3.6 years

 

The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Tactile Biomechanical Sensor Imaging

The Kegel perineometer or vaginal manometer was developed as an instrument to measure the strength of voluntary contractions of the pelvic floor muscles. Using the perineometer ascertains the air pressure inside the vagina when asking the woman to squeeze as hard as possible, which indicates whether doing Kegel exercises would be beneficial. Assessment of the pelvic floor strength can also be performed digitally by the physician during a gynecological exam digitally to identify women with fascial defects of the pelvic floor. The Kegel perineometer and digital examinations are said to identify those women at risk of genital prolapse or urinary incontinence. Based on review of the peer reviewed medical literature additional studies are needed to evaluate the applications, strengths, and limitations of this type of tactile imaging for diagnostic use. There are currently no professional guidelines and position statements that support the use of vaginal tactile imaging or biomechanical tactile sensor imaging for any gynecological or non-gynecological condition. 

 

The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Laser Therapy (GeniTyte Procedure)

The GeniTyte procedure is a new treatment approach for the treatment of stress urinary incontinence. It involves the use laser that stimulates the skin’s natural production of collagen making it more supple and elastic. GeniTyte works to regain bladder control by tightening the tissue around the urethra.  The number of treatments needed to restore the function of a woman’s urethra supposedly depends largely on how much collage is still present in her skin.  The clinical value of the GeniTyte procedure needs to be validated by well-designed studies. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Periurethral Bulking Agents for the Treatment of Vesicoureteral Reflux (VUR)

Most commonly seen in children, vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder upward toward the kidney. The primary management strategies have been prophylactic antibiotics to reduce urinary tract infections and, for higher grade disease, surgical correction of the underlying reflux. Injection of periureteral bulking agents is proposed as an alternative to surgical intervention.

 

Vesicoureteral reflux (VUR) predisposes patients to urinary tract infections (UTIs) and renal infection (pyelonephritis) by facilitating the transport of bacteria from the bladder to the upper urinary tract. Pyelonephritis causes renal scarring in as many as 40% of children, and extensive scarring may lead to renal insufficiency and hypertension. The period between first renal scarring from pyelonephritis and the development of hypertension or end-stage renal disease can be 30 to 40 years.

 

In most cases, VUR is diagnosed after a febrile UTI episode or abnormality seen on ultrasound imaging. Approximately one-third of children with UTIs are found to have VUR. The average age for UTI onset is 2 to 3 years, corresponding to the age when toilet training occurs. The criterion standard for diagnosis is voiding cystourethrography, a procedure that involves catheterization of the bladder. Voiding cystourethrography is indicated if renal and bladder ultrasonography reveals hydronephrosis, scarring, or other findings that would suggest either high-grade VUR or obstructive uropathy, as well as in other atypical or complex clinical circumstances. The severity of reflux is described by a grade, typically with the International Reflux Study Group grading system, which grades severity from I (reflux partway up the ureter) to V (massive reflux of urine up the ureter with marked tortuosity and dilation of the ureter and calyces).

 

Treatment strategies for VUR include bladder training, antibiotic prophylaxis, and surgical modification of the ureter to correct the underlying reflux. Open surgical treatment is typically reserved for patients with high-grade reflux (grades III and IV) or as salvage therapy for those who are noncompliant with antibiotic therapy or have breakthrough UTIs while receiving prophylactic therapy. Surgical management involves lengthening the intramural ureter by modification of the ureterovesical attachment with reimplantation of the ureter.

 

Treatment of VUR remains controversial. There is a lack of good evidence that VUR actually increases the risk of pyelonephritis and renal scarring, and the long period of time before renal scarring, hypertension, and end-stage renal disease makes these serious conditions difficult to study. Moreover, VUR has a relatively high rate of spontaneous resolution (>60% over 5 years), so many children may not benefit from treatment. An important challenge is to identify the subset of children most likely to benefit from VUR treatment. At present, in the absence of definitive answers on the utility of treating VUR or the best treatment option, antibiotic prophylaxis to prevent recurrent UTIs and surgery to treat the underlying reflux remain accepted management strategies.

 

The use of bulking agents in the treatment of VUR has been reported for more than 20 years and suggested as an alternative to antibiotic and surgical therapy. Bulking agents can be injected into tissue around the ureteral orifices to minimize reflux. The STING procedure (subureteral transurethral injection) involves the endoscopic injection of a bulking agent into the submucosal bladder wall just below the ureteral opening. In the modified STING procedure, the needle is placed in the ureteral tunnel, and the bulking agent is injected into the submucosal intraureteral space. When successfully injected, the compound tracks along the length of the detrusor tunnel and establishes a coapted ureteral tunnel. More recently, the HIT (hydrodistension of the ureteric orifice and injection of bulking agents in the mid to distal submucosal tunnel at the 6 o'clock position) and double HIT (modified HIT with proximal and distal intraluminal submucosal injections) techniques have gained favor; a meta-analysis revealed that overall VUR resolution was 82.5% with HIT as compared to 71.4% with STING (p<0.00001). These endoscopic procedures can be performed in an outpatient setting.

 

A variety of bulking agents have been tested for biocompatibility and absence of migration, in 2001, Deflux (dextranomer/hyaluronic acid copolymer) was approved by the U.S. Food and Drug Administration (FDA) for the "treatment of children with vesicoureteral reflux (VUR) grades II-IV" and remains the only FDA approved bulking agent for VUR.

 

For children who have VUR who have failed medical therapy and are eligible for surgery who receive endoscopic treatment with periureteral bulking agents, the evidence includes randomized controlled trials and systematic reviews. Overall, studies have reported similar rates of reflux resolution compared with ureteral reimplantation surgery and the body of evidence would suggest that morbidity rates are similar or lower with bulking agents. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

For children who have VUR who have not failed medical therapy and may be ineligible for surgery who receive endoscopic treatment with periureteral bulking agents, the evidence includes randomized controlled trials. The randomized controlled trials, which had relatively small sample sizes in each arm, compared periureteral bulking agents with antibiotic prophylaxis and/or surveillance only and reported mixed findings. Additional, larger studies are needed before conclusions can be drawn about the efficacy of periureteral bulking agents as first-line treatment for patients with VUR. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Practice Guidelines and Position Statements

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. 

 

The American Urological Society

In 2019, the American Urological Society and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction published guidelines on the diagnosis and treatment of non-neurogenic overactive bladder (OAB) in adults that included the following recommendations: 

 

Guideline Statements
Diagnosis
  1. The clinician should engage in a diagnostic process to document symptoms and signs that characterize OAB and exclude other disorders that could be the cause of the patient's symptoms; the minimum requirements for this process are a careful history, physical exam, and urinalysis. Clinical Principle
  2. In some patients, additional procedures and measures may be necessary to validate an OAB diagnosis, exclude other disorders and fully inform the treatment plan. At the clinician's discretion, a urine culture and/or post-void residual assessment may be performed and information from bladder diaries and/or symptom questionnaires may be obtained. Clinical Principle
  3. Urodynamics, cystoscopy and diagnostic renal and bladder ultrasound should not be used in the initial workup of the uncomplicated patient. Clinical Principle
  4. OAB is not a disease; it is a symptom complex that generally is not a life-threatening condition. After assessment has been performed to exclude conditions requiring treatment and counseling, no treatment is an acceptable choice made by some patients and caregivers. Expert Opinion
  5. Clinicians should provide education to patients regarding normal lower urinary tract function, what is known about OAB, the benefits versus risks/burdens of the available treatment alternatives and the fact that acceptable symptom control may require trials of multiple therapeutic options before it is achieved. Clinical Principle

 

Treatment:

First-Line Treatments: Behavioral Therapies

  1. Clinicians should offer behavioral therapies (e.g., bladder training, bladder control strategies, pelvic floor muscle training, fluid management) as first line therapy to all patients with OAB. Standard (Evidence Strength Grade B)
  2. Behavioral therapies may be combined with pharmacologic management. Recommendation (Evidence Strength Grade C)

 

Second-Line Treatments: Pharmacologic Management

  1. Clinicians should offer oral anti-muscarinics or oral β3-adrenoceptor agonists as second-line therapy. Standard (Evidence Strength Grade B)
  2. If an immediate release (IR) and an extended release (ER) formulation are available, then ER formulations should preferentially be prescribed over IR formulations because of lower rates of dry mouth. Standard (Evidence Strength Grade B)
  3. Transdermal (TDS) oxybutynin (patch or gel) may be offered. Recommendation (Evidence Strength Grade C)
  4. If a patient experiences inadequate symptom control and/or unacceptable adverse drug events with one anti-muscarinic medication, then a dose modification or a different anti-muscarinic medication or a β3-adrenoceptor agonist may be tried. Clinical Principle
  5. Clinicians may consider combination therapy with an anti-muscarinic and β3-adrenoceptor agonist for patients refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists. Option (Evidence Strength Grade B)
  6. Clinicians should not use anti-muscarinics in patients with narrow-angle glaucoma unless approved by the treating ophthalmologist and should use anti-muscarinics with extreme caution in patients with impaired gastric emptying or a history of urinary retention. Clinical Principle
  7. Clinicians should manage constipation and dry mouth before abandoning effective anti-muscarinic therapy. Management may include bowel management, fluid management, dose modification or alternative anti-muscarinics. Clinical Principle
  8. Clinicians must use caution in prescribing anti-muscarinics in patients who are using other medications with anti-cholinergic properties. Expert Opinion
  9. Clinicians should use caution in prescribing anti-muscarinics or β3-adrenoceptor agonists in the frail OAB patient. Clinical Principle
  10. Patients who are refractory to behavioral and pharmacologic therapy should be evaluated by an appropriate specialist if they desire additional therapy. Expert Opinion

 

Third-Line Treatments: PTNS and Neuromodulation

  1. Clinicians may offer intradetrusor onabotulinumtoxinA (100U) as third-line treatment in the carefully-selected and thoroughly-counseled patient who has been refractory to first- and second-line OAB treatments. The patient must be able and willing to return for frequent post-void residual evaluation and able and willing to perform self-catheterization if necessary. Standard (Evidence Strength Grade B)
  2. Clinicians may offer peripheral tibial nerve stimulation (PTNS) as third-line treatment in a carefully selected patient population. Recommendation (Evidence Strength Grade C)
  3. Clinicians may offer sacral neuromodulation (SNS) as third-line treatment in a carefully selected patient population characterized by severe refractory OAB symptoms or patients who are not candidates for second-line therapy and are willing to undergo a surgical procedure. Recommendation (Evidence Strength Grade C)
  4. Practitioners and patients should persist with new treatments for an adequate trial in order to determine whether the therapy is efficacious and tolerable. Combination therapeutic approaches should be assembled methodically, with the addition of new therapies occurring only when the relative efficacy of the preceding therapy is known. Therapies that do not demonstrate efficacy after an adequate trial should be ceased. Expert Opinion

 

Fourth-Line Treatments: Augmentation Cystoplasty and Urinary Diversion

  1. In rare cases, augmentation cystoplasty or urinary diversion for severe, refractory, complicated OAB patients may be considered. Expert Opinion

 

Additional Treatments:

  1. Indwelling catheters (including transurethral, suprapubic, etc.) are not recommended as a management strategy for OAB because of the adverse risk/benefit balance except as a last resort in selected patients. Expert Opinion 

 

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 colosuspension 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

In 2018, the European Association of Urology conducted a review of therapies for urinary incontinence that included the following recommendations:

  • They found that botulinum toxin, PTNS, and sacral nerve stimulation may be effective treatments for OAB. There was no high-quality evidence showing the superiority of one therapy over another. Age, comorbidities, patient preference, and surgical expertise were factors to be considered when treatment decisions are made.
  • "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)

 

Regulatory Status

In 2005, the Urgent® PC Neuromodulation System was the initial PTNS device cleared for marketing by FDA through the 510(k) process to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence. Additional percutaneous tibial nerve stimulators have been cleared for marketing through the 510(k) process. They are listed in Table 1.

 

The Urgent® PC Neuromodulation System and NURO™ Neuromodulation System are not FDA cleared for other indications, such as the treatment of fecal incontinence.

 

Wireless technology is evolving for the treatment of overactive bladder; it is approved in Europe. BlueWind (BlueWind Medical) is a wireless, battery-less, miniature implantable neurostimulator activated by an external device worn at the ankle.

 

Table 1. FDA-Cleared Percutaneous Tibial Nerve Stimulators (FDA Product Code: NAM)

Device Name Manufacturer Cleared Indications
Urgent® PC Neuromodulation System Uroplasty, now Cogentix Medical Oct 2005 Treatment of urinary urgency, urinary frequency, and urge incontinence
Urgent® PC Neuromodulation System Uroplasty, now Cogentix Medical Jul 2006 FDA determined the 70% isopropyl alcohol prep pad contained in the kit is subject to regulation as a drug
Urgent® PC Neuromodulation System Uroplasty, now Cogentix Medical Aug 2007 Labeling update, intended use is unchanged
Urgent® PC Neuromodulation System Uroplasty, now Cogentix Medical Oct 2010 Intended use statement adds the diagnosis of overactive bladder
NURO™ Neuromodulation System Advanced Uro-Solutions, now Medtronic Nov 2013 Treatment of patients with overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence

 

Several periurethral bulking agents have been approved by FDA through the premarket approval process and products include:

  • In 1999, Durasphere (Advanced UroScience), a pyrolytic carbon-coated zirconium oxide sphere was approved for treatment of adult women with stress-type urinary incontinence caused by intrinsic sphincter insufficiency (ISD).
  • In 2001 Deflux (dextranomer/hyaluronic acid) was approved for use in children with reflux grades II-IV.
  • In 2004, Uryx (CR Bard) a vinyl alcohol copolymer implant was approved for the treatment of adult women diagnosed with stress urinary incontinence due to intrinsic sphincter deficiency (ISD).
  • In 2005, Coaptite (Merz Aesthetics, previously BioForm Medical) spherical particles of calcium hydroxylapatite, suspended in a gel carrier was approved for the treatment of stress urinary incontinence (ISD) due to intrinsic sphincteric deficiency in adult women.
  • In 2006, Macroplastique (Cogentix Medical), polydimethylsiloxane was approved in the treatment of adult women diagnosed with stress urinary incontinence primary due to intrinsic sphincter deficiency (ISD).
  • In 2020, Bulkamid (polyacrylamide hydrogel) (Axonics Modulation Technologies, Inc) was approved for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.

 

In 2002, the SURx Transvaginal System received marketing clearance through the U.S. Food and Drug Administration (FDA) 510(k) process. According to the FDA, the device “is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.” As of 2006, the SURx is no longer marketed in the U.S.

 

In 2005, Novasys Medical received clearance to market the Renessa® transurethral radiofrequency system through the FDA 510(k) process. The device is indicated for the transurethral treatment of stress urinary incontinence due to hypermobility. In 2013, Verathon acquired Renessa® by Novasys Medical®, and rebranded it as the Lyrette™.

 

The inFlow 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"

 

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. 

 

Prior Approval:

Not applicable

 

Policy:

See Related Medical Policies:

  • 08.01.21 Sacral Nerve Stimulation/Neuromodulation
  • 02.01.04 Anorectal Biofeedback
  • 02.01.51 Fecal Incontinence Management

 

Periurethral Bulking Agents for the Treatment of Stress Urinary Incontinence (L8603, L8606 and 51715)

The following periurethral bulking agents may be considered medically necessary to treat stress urinary incontinence due to urethral sphincter deficiency (ISD) for individuals who are unresponsive to conservative therapy* for at least 3 months:

  • Durasphere (carbon-coated spheres)
  • Coaptite (calcium hydroxylapatite)
  • Macroplastique (polydimehylsiloxan) 
  • Crossed-link collagen bulking agents
  • Bulkamid (polyacrylamide hydrogel)
  • Uryx (ethylene vinyl alcohol copolymer)

 

*Conservative therapy for stress urinary incontinence may include:

  • Pelvic floor muscle exercises (Kegel exercises)/supervised pelvic floor therapy
  • Behavioral changes, such as:
    • Fluid management
    • Smoking cessation
    • Weight loss
    • Moderation of physical activities that provoke stress urinary incontinence
  • Intravaginal estrogen therapy
  • Use of pessary
  • Treatment of other underlying causes of stress incontinence in patients amendable to these treatments

 

Individuals who have a reoccurrence of stress urinary incontinence due to urethral sphincter deficiency (ISD) following successful treatment with one of the above periurethral bulking agents in the past months (6 to 12 months previously) may benefit from additional treatment sessions and coverage of these additional sessions may be considered medically necessary when supported by medical record documentation. 

 

Individuals whose stress urinary incontinence due to urethral sphincter deficiency (ISD) that does not improve with five injection procedures (five separate treatment sessions) are considered treatment failures and any further treatment with a periurethral bulking agent above may be considered not medically necessary.

 

Individuals not meeting the criteria above for the use of periurethral bulking agents for the treatment of stress urinary incontinence due to urethral sphincter deficiency (ISD) may be considered not medically necessary.

 

The use of periurethral bulking agents as a treatment for any other type of urinary incontinence is considered investigational due to the lack of clinical evidence demonstrating an impact on improved net health outcomes. 

 

Periurethral Bulking Agents for the Treatment of Vesicoureteral Reflux (L8604 and 52327)

Periurethral bulking agent Deflux (dextranomer/hyaluronic acid) may be considered medically necessary as a treatment of children (21 years and less) with vesicoureteral reflux (VUR) grades II, III, or IV* when medical therapy has failed, and is eligible for surgical intervention.

 

The use of periurethral bulking agent Deflux (dextranomer/hyaluronic acid) is considered investigational for all other indications due to the lack of clinical evidence demonstrating an impact on improved net health outcomes.

 

*The International Reflux Grading system classifies vesicoureteral reflux VUR into 5 grades, depending on the degree of retrograde filling and dilation of the renal collecting system. This system is based on the radiographic appearance of the renal pelvis and calyces on a voiding cystogram, as follows:

  • Grade I: Urine backs up into the ureter only, and the renal pelvis appears healthy, with sharp calyces.
  • Grade II: Urine backs up into the ureter, renal pelvis, and calyces. The renal pelvis appears healthy and has sharp calyces.
  • Grade III: Urine backs up into the ureter and collecting system. The ureter and pelvis appear mildly dilated, and the calyces are mildly blunted.
  • Grade IV: Urine backs up into the ureter and collecting system. The ureter and pelvis appear moderately dilated, and the calyces are moderately blunted.
  • Grade V: Urine backs up into the ureter and collecting system. The pelvis severely dilates, the ureter appears tortuous, and the calyces are severely blunted.

 

Artificial Urinary Sphincter (AUS) (C1815, 53445, 53446, 53447, 53449)

The implantation of an artificial urinary sphincter (AUS) may be considered medically necessary for the treatment of urinary incontinence (UI) due to intrinsic sphincter deficiency (ISD) for members who are 6 or more months post-prostatectomy who have had no improvement in the severity of urinary incontinence (UI) despite trials of behavioral (bladder training, prompted voiding, or pelvic muscle exercise training) and pharmacological therapies.

 

Note: The implantation of an artificial urinary sphincter (AUS) is not considered first-line treatment of refractory urinary incontinence (UI) in members following prostate surgery. Examples of first-line conservative therapy may include one or more of the following: behavioral therapy, pharmacologic treatments, and intermittent self-catheterization.

 

The implantation of an artificial urinary sphincter (AUS) may be considered not medically necessary not meeting the above criteria and for all other indications.

 

Posterior Tibial Nerve Stimulation (PTNS) (64566, 0587T, 0588T, 0589T, 0590T)

Posterior tibial nerve stimulation (PTNS) (also known as percutaneous tibial nerve stimulation) for an initial 12-week course may be considered medically necessary for individuals with non-neurogenic urinary dysfunction including overactive bladder who have ALL of the following:

  • failed behavioral therapy following an appropriate duration of 8 to 12 weeks without meeting treatment goals; and
  • failed pharmacologic therapy following 4 to 8 weeks of treatment without meeting treatment goals

 

Maintenance therapy using monthly posterior tibial nerve stimulation (PTNS) (also known as percutaneous tibial nerve stimulation) may be considered medically necessary for individuals following a 12-week initial course of posterior tibial nerve stimulation (PTNS) (also known as posterior tibial nerve stimulation) that resulted in improved urinary dysfunction meeting treatment goals.

 

Note: Annual evaluation by a physician may be performed to ensure efficacy is continuing for maintenance posterior tibial nerve stimulation (PTNS) (also known as percutaneous tibial nerve stimulation).

 

Notes:

  • Common causes of non-neurogenic voiding dysfunction are pelvic floor neuromuscular changes (e.g., from pregnancy, childbirth, surgery), inflammation, medication (e.g., diuretics, anticholinergics), obesity, and psychogenic factors. Overactive bladder is a non-neurogenic voiding dysfunction characterized by urinary frequency, urgency, urge incontinence, and nonobstructive retention.
  • Neurogenic bladder dysfunction is caused by neurologic damage in patients with multiple sclerosis, spinal cord injury, detrusor hyperreflexia, or diabetes with peripheral nerve involvement. The symptoms include overflow incontinence, frequency, urgency, urge incontinence, and retention.

 

Posterior tibial nerve stimulation (PTNS) (also known as percutaneous tibial nerve stimulation) not meeting the above criteria and for all other indications may be considered not medically necessary. 

 

Note: For Posterior tibial nerve stimulation (PTNS) (also known as percutaneous tibial nerve stimulation) for the treatment of fecal incontinence see medical policy 02.01.51 Fecal Incontinence Management which denies investigational for this indication.

Investigational Therapies for the Treatment of Urinary Incontinence/Urinary Dysfunction

The following treatments and devices are considered investigational for the treatment of urinary incontinence/urinary dysfunction due to the lack of clinical evidence demonstrating an impact on improved net health outcomes:

  • Biofeedback 
    • Electromyography EMG biofeedback
    • Visual Biofeedback and Guided Exercise Program (Attain)
  • Vaginal weight training with specially designed weights (cones) 
  • Pelvic floor stimulation by any method, electrical or magnetic (ExMI)
  • Transvaginal and transurethral radiofrequency energy therapies for bladder neck suspension, including, but not limited to, the Lyrette Transurethral SUI System (previously known as Renessa System), and the SURx Radiofrequency Bladder Neck Suspension System
  • Laser therapy (Genityte procedure) 
  • Transperineal Implantation of Permanent Adjustable Balloon Continence Device (ProACT)
  • The inFlow intraurethral valve-pump implantation 
  • Tactile biomechanical sensor imaging (transvaginal biomechanical imaging)

 

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.

  • C1815 Prosthesis, urinary sphincter (implantable)
  • E0740 Non-implanted pelvic floor electrical stimulator, complete system
  • E0746 Electromyography (EMG), biofeedback device
  • E1399 Durable Medical Equipment, miscellaneous (may be utilized for Attain Urinary Incontinence Device)
  • L8603 Injectable bulking agent, collagen implant, urinary tract, 2.5 ml syringe, includes shipping and necessary supplies (Cross-Linked Collagen Bulking Agents)
  • L8604 Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, urinary tract, 1 ml, includes shipping and necessary supplies (Deflux)
  • L8606 Injectable bulking agent, synthetic implant, urinary tract, 1 ml syringe, includes shipping and necessary supplies (Durasphere, Coaptite, Macroplastique, Blukamid, Uryx)
  • 51715 Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck
  • 52327 Cystourethroscopy (including ureteral catheterization); with subureteric injection of implant material
  • 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
  • 53899 Unlisted procedure, urinary system (may be indicated for ExMi)
  • 58999 Unlisted procedure, female genital system (nonobstetrical) (may be indicated for ExMi)
  • 64566 Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming
  • 97014 Application of a modality to 1 or more areas; electrical stimulation (unattended)
  • 97039 Unlisted modality (specify type and time if constant attendance) (may be indicated for Vaginal weight training with specially designed weights [cones])
  • 97032 Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes
  • 0487T Biomechanical mapping, transvaginal, with report
  • 0548T Transperineal periurethral balloon continence device; bilateral placement, including cystoscopy and fluoroscopy (ProACT system)
  • 0549T Transperineal periurethral balloon continence device; unilateral placement, including cystoscopy and fluoroscopy (ProACT system)
  • 0550T Transperineal periurethral balloon continence device; removal, each balloon (ProACT system)
  • 0551T Transperineal periurethral balloon continence device; adjustment of balloon(s) fluid volume (ProACT system)
  • 0587T Percutaneous implantation or replacement of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve
  • 0588T Revision or removal of integrated single device neurostimulation system including electrode array and receiver or pulse generator, including analysis, programming, and imaging guidance when performed, posterior tibial nerve
  • 0589T Electronic analysis with simple programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 1-3 parameters
  • 0590T Electronic analysis with complex programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 4 or more parameter
  • 0596T Temporary female intraurethral valve-pump (ie, voiding prosthesis); initial insertion, including urethral measurement (inFlow intraurethral valve-pump implantation)
  • 0597T Temporary female intraurethral valve-pump (ie, voiding prosthesis); replacement (inFlow intraurethral valve-pump implantation)

 

Selected References:

  • 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. 
  • Chung E. Artificial urinary sphincter surgery in the special populations: neurological, revision, concurrent penile prosthesis and female stress urinary incontinence groups. Asian J Androl 2020;22:45-50
  • Peyronnet B, Capon G, Belas O, Manunta A, Allenet C, et al. Robot-assisted AMS-800 artificial urinary sphincter bladder neck implantation in female patients with stress urinary incontinence. Eur Urol 2019; 75: 169–75
  • Lin HY, Tsai HW, Tsui KH, et al. The short-term outcome of laser in the  anagement of female pelvic floor disorders: Focus on stress urine incontinence and sexual dysfunction. Taiwan J Obstet Gynecol. 2018;57(6):825-829.
  • Gonzalez Isaza P, Jaguszewska K, Cardona JL, Lukaszuk M. Longterm effect of thermoablative fractional CO2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopause. Int Urogynecol J. 2018;29(2):211-215.
  • Peng L, Zeng X, Shen H, Luo DY. Magnetic stimulation for female patients with stress urinary incontinence, a meta-analysis of studies with short-term follow-up. Medicine (Baltimore). 2019;98(19):e15572.
  • American Urological Association (2019) Diagnosis and Treatment of Non-Neurogenic Overactive Bladder (OAB) in Adults: an AUA/SUFU Guideline.
  • UpToDate. Treatment of Urinary Incontinence in Females. Emily S. Luckaz M.D., MAS, topic last updated October 19, 2020. 
  • UpToDateUrinary incontinence in men. L Quentin Clemens M.D., FACS, MSCI topic last updated December 2, 2019. 
  • UpToDate. Urgency urinary incontinence/overactive bladder (OAB) in females: Treatment. Topic last updated May 18, 2021. 
  • Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, et. al. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: randomized control trial. Neurourol Urodyn 2019 Jan;38(1):261-268. PMID 30311692
  • Tutolo M, Ammirati E, Van der Aa F. What is new in neuromodulation for overactive bladder? Eur Urol Focus 2018 Jan;4(1):49-53. PMID 29773501
  • Zonic-Imamovic M, Immaovic, Cickusic A, et. al. Effects of treating an overactive urinary bladder in patients with Multiple Sclerosis. Acta Med Acad 2019 Dec;48(3):271-277. PMID 32124625
  • Welk B. McKibbon M. A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients. Can Urol Assoc J. 2020 Jul;14(7):E297-E303. PMID 32017693
  • Kavanagh A, Baverstock R, Campeau L et. al. Canadian Urological Association guideline: Diagnosis, management, and surveillance of neurogenic lower urinary tract dysfunction. Can Urol Assoc J. 2019 Jun;13(6): E157-E176. PMID 30763235
  • Marcelissen T,  Cornu JN, Antunes-Lopes T, et. al. Management of idiopathic overactive bladder syndrome: what is the optimal strategy after failure of conservative treatment? Eur Urol Focus 2018 Sep;4(5):760-767. PMID 29807823
  • Boswell T, Elliott D, Rangel L, et. al. Long-term device survival and quality of life outcomes following artificial urinary sphincter placement. Transl Androl Urol 2020 Feb;9(1):56-61. PMID 32055467
  • Capobianco G, Saderi L, Dessole F, et. al. Efficacy and effectiveness of bulking agents in the treatment of stress and mixed urinary incontinence: a systematic review and meta-analysis. Maturitas 2020 Mar;133:13-31. PMID 32005420
  • Bomba P, Florez F, Garcia F, et. al. Effectiveness of surgical management with an adjustable sling versus an artificial urinary sphincter in patients with severe urinary post-prostatectomy incontinence: a systematic review and network meta-analysis. Ther Adv Urol 2019 Jan-Dec; 11 PMID 31632464
  • Sacomani C, Zequi S, da Costa W, 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 Jan-Feb 44(1):114-120. PMID 29211407
  • Tutolo M, Cornu JN, Bauer R, et. al. Efficacy and safety of artificial urinary sphincter (AUS): Results of a large multi-institutional cohort of patients with mid-term follow-up. Neurourol Urondyn 2019 Feb;38(2):710-718. PMID 30575997
  • Kirchin V, Page T, Keegan P, et. al. Uretheral injection therapy for urinary incontinence in women. Cochran Database Syst Rev 2017 Jul;2017(7). PMID 28738443
  • Kobashi KC, Albo ME, Dmochowski RR, et. al. Surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU Guideline (2017). J Urol 2017;198:875
  • Deflux
  • Bulkamid FDA approval
  • Uryx FDA approval  

 

Policy History:

  • June 2021 - Annual Review, Policy Revised
  • June 2020 - Annual Review, Policy Revised
  • 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 Renewed
  • May 2014 - Interim Review, Policy Revised
  • September 2013 - Annual Review, Policy Revised
  • October 2012 - Annual Review, Policy Renewed
  • October 2011 - Annual Review, Policy Renewed
  • September 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.