This policy addresses the treatment of urinary incontinence or urinary retention including behavioral training, collagen therapy, sacral nerve stimulation, surgical treatment, artificial urinary sphincter implantation, urethral bulking agents, biofeedback, transvaginal radiofrequency bladder neck suspension, percutaneous tibial nerve stimulation and transurethral radiofrequency energy collagen micro-remodeling.

Note: Botulinum toxin as a treatment of incontinence or bladder detrusor sphincter dyssynergia is addressed separately in DRUG.00006 Botulinum Toxin.

Medically Necessary:

The following treatments for adult urinary incontinence are considered medically necessary:

1. Behavioral training such as bladder training, prompted voiding, pelvic muscle exercise training (except for those services specifically listed below as investigational)
   

2. Periurethral bulking agents (e.g., cross linked collagen [Contigen], carbon coated beads [Durasphere®], copolymer [Tegress™ formerly named URYX®]), calcium hydroxylapatite [Coaptite®] or polydimethylsiloxane [Macroplastique®] when all of the following are met:
   
   

   1. One of the following indications:
      
      
      1. Stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency (ISD); or
      2. Post-traumatic or post-surgical injury; or
      3. Urethral hypermobility in females with abdominal leak point less than 100 cm H20; and
         
         
   2. Incontinence is not improved after at least 12 consecutive months of conventional therapy (e.g., exercise,  medication) except for patients with post-traumatic or post-surgical injury where this criteria is not required; and
      
      
   3. One of the following:
      
      
      1. If cross linked collagen is used, up to five (5) injections are considered medically necessary, a minimum of a week apart, since beyond that the patient would be considered a treatment failure; or
      2. If carbon coated beads, copolymer, calcium hydroxylapatite or polydimethylsiloxane is used, up to three (3) injections are considered medically necessary a minimum of a week apart, since beyond that the patient would be considered a treatment failure.
              
         

3. A peripheral nerve evaluation test followed by the placement of a temporary sacral nerve stimulator for urinary urge incontinence and urinary urgency/frequency, when all of the following are met:
   
   

   1. The patient has experienced urge incontinence for a minimum of 12 months duration that is not due to a neurologic condition and has resulted in significant disability (frequency and/or severity impacts ability to work or participate in activities outside of the home); and
      
   2. Patient has failed or could not tolerate a minimum of 12 consecutive months of conservative treatments (exercises, medication).
      
      

4. A peripheral nerve evaluation test followed by the placement of a temporary sacral nerve stimulator for adult non-obstructive urinary retention when  the following are met:
   

   1. The patient has experienced urinary retention for a minimum of 12 months duration that is not due to a neurologic condition and has resulted in significant disability (frequency and/or severity impacts ability to work or participate in activities outside of the home); and
      
      
   2. One of the following additional criteria are met:
      
      
      1. Patient has failed or could not tolerate a minimum of 12 consecutive months of pharmacotherapy or
      2. Intermittent catheterizations have failed or are not well tolerated after a trial of 12 consecutive months
         
   
   

5. A permanent sacral nerve stimulator (e.g., Interstim®) for patients with refractory urge incontinence, urge/frequency incontinence or nonobstructive urinary retention who have had a successful temporary trial and are an appropriate surgical candidate for permanent implantation.
   

   Successful trial is defined as:
   
   
   1. Urinary retention: At least a 50% reduction in catheter volume/catheterization.
   2. Urinary urge incontinence: At least 50% reduction in one of the following: daily incontinence episodes, severity of the episodes or the number of pads/diapers used per day.
   3. Urinary urge/frequency: At least 50% reduction in one of the following: number of voids daily, volume per void and frequency per void.
      
      
6. Surgeries for incontinence in patients who do not respond to other therapy.
   
   

7. Artificial urinary sphincter implantation as a treatment of urinary stress incontinence.

Investigational/Not Medically Necessary:

The following services are considered investigational/not medically necessary:

1. Vaginal weight training with specially designed weights (cones) in all cases.
   
   
2. Biofeedback, electrical or computerized.
   
   
3. Pelvic floor stimulation, including electrical and extracorporeal magnetic innervation (NeoControl® Pelvic Floor Therapy, Novis chair) in all cases.
   
   
4. The injection of periurethral bulking agents, other than those listed above as medically necessary, including but not limited to, Teflon® injections or for individuals who do not meet the medically necessary criteria.
   
   
5. Sacral nerve stimulators for other than medically necessary indications, including but not limited to, the following:
   
   
   1. Urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia);
   2. Stress incontinence and other types of chronic voiding dysfunction.
   3. Permanent implantation of an Interstim® device in patients with chronic pelvic pain, constipation, fecal incontinence or neurologic conditions such as spinal cord injury, diabetic neuropathy or multiple sclerosis.
      
      
6. Transvaginal radiofrequency bladder neck suspension (SURx Transvaginal System) as a treatment of urinary stress incontinence.
   
   
7. Percutaneous tibial nerve stimulation (PTNS) for all indications, including but limited to, treatment of overactive bladder symptoms such as urinary urgency, urinary frequency and urge incontinence, stress incontinence, non-obstructive urinary retention and interstitial cystitis.
   
   
8. Transurethral radiofrequency energy collagen micro-remodeling (e.g., the Renessa™ System) as a treatment of stress urinary incontinence.

Rationale

Behavioral Therapy

Of the many treatments available, behavior therapies have been reported to reduce the number of stress- and urge-incontinence episodes by 50 to 80 percent in randomized controlled trials.

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.

Periurethral Bulking Agents

The safety and efficacy of cross linked collagen and carbon coated beads has been established by well designed, randomized, multicenter trials. Periurethral injections of bulking agents such as cross-linked collagen (e.g., Contigen®), carbon-coated beads (e.g., Durasphere®) copolymer (Tegress™ formerly named URYX®) have all been studied in randomized trials. Durasphere® received FDA approval in 1999; a double blind randomized study comparing the Durasphere® to Contigen® was reported to the FDA as part of the approval process. At the end of the 12-month study period the two devices reported equal effectiveness. More recently, Coaptite® and Macroplastique® were both approved by the FDA. The FDA approval for these agents was based on prospective, randomized, comparative, multicenter, single-blind studies where the bulking agents were used to treat female patients with SUI due to ISD and then evaluated through a 12-month period and compared to a collagen control group. Both agents were equally effective as the control groups with similar rates of treatment-related adverse events.

Tegress™ formerly named URYX®, received FDA approval based on a clinical study showing that 20% of the women were dry and 30% had fewer episodes of incontinence one year after receiving the implant. A repeat injection was necessary in 75% of these patients to achieve satisfactory results.

Teflon injections require using a large-bore needle that the US FDA has not approved because of possible local and distant migration of the Teflon particles into the lymph nodes, lung, and brain.

Sacral Nerve Stimulation

As part of the FDA approval process, the Interstim® device was investigated in a series of randomized clinical trials that demonstrated that the device was effective in significantly reducing urinary symptoms in patients with urge incontinence, urgency frequency and non-obstructive urinary retention.  There is inadequate data regarding the Interstim® device in patients with chronic pelvic pain, constipation, fecal incontinence or neurologic disorders, such as multiple sclerosis or spinal cord injury.  Specifically, there are no randomized trials addressing these indications for sacral neuromodulation.

Surgical Procedures

Surgical procedures for urinary incontinence, such as the Burch colposuspension and the pubovaginal sling, have high success rates – up to 80-90%.  The tension-free vaginal tape procedure has been shown to have objective cure rates for stress urinary incontinence ranging form 74% to 97%.

Artificial Sphincter Implantation

Artificial sphincter implantation has been established through multiple case series studies as an effective therapy for ISD patients who are unable to perform intermittent catheterization and have severe SUI that is unresponsive to other surgical treatments. Because of possible complications, this treatment is not considered first-line therapy.

Pelvic Floor Stimulation

While case series have reported promising outcomes of electrical pelvic floor stimulation, placebo controlled randomized studies have reported inconsistent results regarding stress incontinence, and inconclusive results regarding urge or mixed incontinence. Randomized studies comparing electrical pelvic floor stimulation with other behavioral therapies, i.e. pelvic muscle exercises or vaginal cones, have lacked statistical power to show superior results. Other randomized trials included multimodal therapy, such that the independent contribution of electrical pelvic floor stimulation could not be assessed. A prior assessment by the Agency for Health Care Policy and Research concluded that electrical pelvic floor stimulation could reduce urinary incontinence in women with stress incontinence. However, this assessment was based on data from clinical case series, rather than data from randomized controlled trials.

Recently three randomized studies have been reported. Two studies investigated the use of electrical pelvic floor stimulation in patients with stress incontinence. One small, randomized double-blind study of 27 patients compared a new pattern of electrical stimulation with sham stimulation. The electrical stimulation group showed statistically greater improvement on the quality of life measure, but no between-group differences were observed in other outcome parameters, including pad testing.

A second randomized trial of 60 women compared the effectiveness of electrical stimulation plus biofeedback with pelvic floor exercise. The electrical stimulation-biofeedback group performed better than the pelvic floor exercise group. The paper, however, did not report key clinical outcomes, i.e., improvement and cure as measured by voiding diaries or pad testing. More importantly, due to the combined therapy of electrical stimulation and biofeedback, the independent effect of electrical stimulation was not evaluated.

One double-blind randomized controlled study compared the effects of electrical stimulation with sham treatment in 68 patients with urge incontinence due to detrusor overactivity. Reported outcomes suggested a beneficial treatment effect with electrical stimulation. Based on patient diary, 19% of patients receiving active treatment versus 3% of patients receiving sham treatment were cured, while 81% of active patients versus 32% of sham patients were improved. These differences were statistically significant. The study did not report the more objective pad testing, and given the inconclusive or conflicting results reported in the two earlier studies, additional evidence is needed from well-designed trials to determine the benefits of electrical stimulation for urge incontinence.

Regarding extracorporeal magnetic pelvic floor stimulation, there are no trials demonstrating the superiority of this technique over pelvic floor exercises. Galloway and colleagues (2002) reported an update on the multicenter prospective trial that included 111 women with stress urinary incontinence. A total of 47 women completed 6-month follow-up testing; 38 patients were completely dry or used less than 1 pad per day (81%). Pad use was reduced in 33 patients (70%). Nevertheless, lacking a control group, the influence of patient selection bias on these outcomes cannot be ruled out. One unpublished preliminary report provided by the device manufacturer reported the results of a double-blind randomized trial comparing pelvic floor electromagnetic stimulation with sham treatment for women with stress urinary incontinence. All patients also underwent pelvic floor muscle training. Patients were treated for 20 minutes 3 times a week over 6 weeks. No difference was observed between the two groups for any overall parameter at 8 weeks; however, a significant treatment effect was seen in the subgroup of patients with poor pelvic floor tone at baseline.

Biofeedback

There are several methodological difficulties in assessing biofeedback. For example, most interventions that include biofeedback are multimodal. While studies may report a beneficial effect of multimodality treatment, without appropriate control conditions, it is impossible to isolate the specific contribution of biofeedback to the overall treatment effect.  Among the controlled studies that have attempted to isolate the contribution of biofeedback, the weight of the evidence suggests no additional benefit for biofeedback above that obtained with pelvic floor muscle exercises alone.  A recent evidence-based review of biofeedback as a treatment of incontinence concluded that although there is some evidence suggesting that biofeedback may be helpful for women who have difficulty isolating their pelvic floor muscles, there was inadequate data that shows any clear advantage to combining pelvic floor muscle training with biofeedback over pelvic floor muscle training alone. (Holroyd-Leduc, 2004).

Biofeedback and pelvic floor electrical stimulation are now available to Medicare recipients as second-line treatments for stress and/or urge urinary incontinence.  In two separate national coverage policy revisions, the agency identified patients eligible as those that have already undergone and failed a trial of pelvic muscle floor exercises.  Biofeedback and pelvic floor electrical stimulation is still not considered appropriate for initial use treatment of stress and/or urge urinary incontinence.

Transvaginal Radiofrequency Bladder Neck Suspension

The minimal published literature regarding transvaginal radiofrequency bladder neck suspension is inadequate to permit scientific conclusions regarding the safety and long-term efficacy of these procedures. Dmochowski and colleagues (2003) reported on a multi-institutional prospective case series of 120 consecutive women with urinary stress incontinence who underwent transvaginal bladder neck suspension. Enrolled patients had failed at least a three-month trial of conservative therapy, including most common 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 patient completed a voiding diary and quality of life questionnaire. A cure was defined as a either a negative Valsalva maneuver; improvement was defined as decreased daily episodes of pad use. A total of 73% of patients were considered cured or improved at 12 months. More than 68% of patients reported satisfaction with the treatment. The authors conclude that the results are encouraging and that a 73% 12-month success rate suggests that this procedure has applicability for women with refractory incontinence who do not wish to undergo a more complicated surgical procedure. Ross and colleagues (2002) conducted a multicenter, prospective single-arm study that included 94 women with stress incontinence. At 1 year the objective cure rate was 79% based on a negative leak point pressure. Assessment of quality of life was also significantly improved. Larger controlled studies with longer follow-up are needed to further evaluate this procedure. As noted in a review of laparoscopic bladder neck suspension, (McDougall, 1999) initial promising results at 12 months declined to a 30% success rate at 45 months. These authors suggest that any new surgical technique for the treatment of stress incontinence should have more than 2 years of follow up.

Percutaneous Tibial Nerve Stimulation (PTNS)

The published literature regarding percutaneous tibial nerve stimulation (PTNS) is insufficient to permit conclusions regarding the long-term efficacy of this procedure. The technology of peripheral neuromodulation is still in the relatively early stages of development. Most research in the field has been reported in the last few years with little long-term data available. The bulk of the published studies have been uncontrolled case series. A wide variety of patient populations have been studied, and the inclusion and exclusion criteria used have been variable, as have been both the metrics used to measure responses and the parameters to establish success. Published studies have reported wide variation in degrees of success. The need exists for more randomized, controlled trials as well as data on longer term outcomes. (Cooperberg, 2005).

Transurethral Radiofrequency Energy Collagen Micro-Remodeling 

Transurethral radiofrequency energy collagen micro-remodeling is being investigated as a non-surgical treatment for women with stress urinary incontinence (SUI). There is limited published, peer-reviewed randomized data on this technology, with only short-term follow-up. Several studies also reflect an apparently substantial placebo effect. More prospective, randomized controlled data with longer-term follow-up are necessary to verify both the safety and effectiveness of radiofrequency therapy in treating stress urinary incontinence in women.

Background/Overview

Urinary incontinence (UI) is the inability to hold urine in the bladder. There are several types of urinary incontinence, such as stress-urge incontinence, detrusor instability, and others. Many women experience some incontinence after childbirth, and with increasing age. Many men experience incontinence along with prostate problems.

Behavioral Methods: Several types of behavioral methods are used for treating urinary incontinence: bladder training, habit training, biofeedback, and pelvic muscle exercises. Men who have functional incontinence can try timed voiding and prompted voiding.

Bladder training: Bladder training (also called bladder retraining) is used to treat urge incontinence. Bladder training attempts to increase the intervals between urinating. A health professional will teach a person about the structure of the lower urinary tract and the causes of incontinence. A voiding schedule is first established. Then the person is trained to resist the first urge to urinate and refrain from urinating until the scheduled time. The intervals between scheduled bathroom visits are increased until the person can refrain from urinating for several hours.

 

Biofeedback: Biofeedback is a relaxation technique for learning to control a body function that is not normally under conscious control, such as skin temperature, muscle tension, heart rate, or blood pressure. Men with incontinence are taught bladder-sphincter biofeedback methods along with pelvic floor exercises. These techniques record bladder, rectal sphincter, and abdominal pressures, as well as electrical activity. As it is recorded, the information is displayed for the person. By watching the information, the person learns to relax the bladder and abdominal muscles and contract the pelvic floor muscles based on the information displayed. Learning biofeedback requires practice in a lab or other setting under the guidance of a trained therapist. Home biofeedback units also are available.

 

Timed voiding: Timed voiding is also called habit training. It is used to treat urge and functional incontinence. It sets a schedule for urinating that is determined by the person's own habits and does not attempt to increase the time between urinating or to teach the person to resist the urge to urinate.

 

Prompted voiding: Prompted voiding is used to treat functional incontinence. It trains a caregiver to prompt the incontinent person to urinate. The goal is to decrease the chance of accidents by making the person aware of the need to urinate periodically. Prompted voiding usually is used in combination with timed voiding for people who are unaware of their bodily functions, such as people who have dementia.

A number of medications are available that increase sphincter or pelvic muscle strength or relax the bladder, thus increasing its capacity to hold urine. Medications that have been proven to be effective for the treatment of stress urinary incontinence include anticholinergic agents (e.g., oxybutin, imipramine); alpha-adrenergic agents (e.g., pseudoephedrine, ephedrine); and estrogen replacement agents (e.g., conjugated estrogens); however, their utility may be limited by their side-effect profile.

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

A sacral nerve stimulator is a device that is surgically implanted into the patient (different from pelvic floor electrical stimulator) to treat urge incontinence. Patients undergo a percutaneous nerve evaluation which confirms integrity of the peripheral nerves and feasibility of stimulation, identifies the optimal site for a temporary stimulation trial and allows for the actual temporary stimulation test to determine their response and whether they are a candidate for the permanent device (Walsh, 2002). This 'trial' procedure is done under local anesthesia, using a test needle to identify the appropriate sacral nerve(s). A temporary wire lead is inserted through the test needle and connected to an external stimulator. The patient monitors his/her voiding symptoms for several days while the device is functioning. If the patient shows a 50% or greater reduction in incontinence frequency, he/she is considered eligible for the permanent device. Implantation of the permanent device is done under general anesthesia.  The rate of adverse events is high: about 20% experienced an event during peripheral nerve evaluation testing, and 50% experienced one or more events following implantation. Most of these are minor, and resolve with treatment, or device revision. Adverse effects include post-implant pain, infection, adverse changes in bowel function, lead migration, and electric shock sensation.

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.

Pelvic floor stimulators are electrical or magnetic nonimplanted devices that may be used to send electrical signals or magnetic pulses to the muscles in and around the bladder area. One type of device is placed inside the vagina and sends electrical signals to either "exercise" the bladder muscle, or to keep the bladder from emptying at the wrong time.  The NeoControl pelvic floor system (Novis chair) is a specially designed chair with a power control unit that allows a magnetic pulse to penetrate the patient's perineal area.  These devices require further research to compare them to existing standard treatments.

The use of an artificial urinary sphincter implant is also an option in patients suffering from urinary incontinence.  This device includes an inflatable cuff that is placed around the urethra and an inflation pump placed in the scrotum.  The device automatically mimics the function of a natural sphincter by keeping tension on the urethra, preventing the flow of urine.  A patient squeezes the pump in the scrotum to release the pressure to allow voiding of the bladder.  The valve automatically re-tightens itself several minutes later.  The only device currently available for this use is the AMS Sphincter 800 Urinary Prosthesis.

The SURx Transvaginal System, which received FDA approval 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. 

The tension-free vaginal tape (TVT) procedure is a minimally invasive sling procedure used in the management of female stress urinary incontinence. It is based on the theory that SUI in women is mainly due to the laxity of vaginal connective tissue. The mesh tape is implanted around the midurethra and held in place by friction. It is designed to provide support when needed and then be in a tension-free state at all other times.

Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation treatment designed to provide sacral nerve stimulation through percutaneous electrical stimulation of the tibial nerve. Sacral neuromodulation involves stimulation of the sacral nerve plexus which regulated bladder and pelvic floor function. The Urgent® PC Neuromodulation System, which received FDA approval in October 2005, is intended to treat symptoms of an overactive bladder such as urinary urgency, urinary frequency and urge incontinence.

Transurethral radiofrequency energy collagen micro-remodeling is a non-surgical treatment for women with stress urinary incontinence (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. received FDA approval in July 2005.

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

Neuromodulation: electrical stimulation of a nerve

Overflow incontinence: the bladder overfills without causing a sensation to urinate

Periurethral: around the urethra, which is the natural channel or tube through which urine passes from the bladder to outside the body

Sacral nerve stimulation: a permanent implantable device that stimulates the neural pathways controlling bladder function

Stress incontinence:characterized by the leakage of urine during physical activities that increase pressure on the bladder

Sphincter:a ring-like band of muscle fibers that constrict a passage or close a natural opening

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

Urinary retention: the inability to completely empty the bladder of urine

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 policy 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.

Artificial sphincter surgery
When services are Medically Necessary:

CPT

ICD-9 Procedure

ICD-9 Diagnosis

Injection of implant material and sacral nerve stimulator procedures
When services may be Medically Necessary when criteria are met:

CPT

HCPCS

ICD-9 Procedure

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:
For the procedure codes listed above when criteria are not met; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

When services may also be Medically Necessary when criteria are met:

CPT

HCPCS

ICD-9 Procedure

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above when criteria are not met; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

Other procedures
When services are Investigational/Not Medically Necessary:

CPT

HCPCS

ICD-9 Diagnosis

When services are also Investigational/Not Medically Necessary:

CPT

HCPCS

ICD-9 Diagnosis

References

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37. Petrou SP, Elliott DS, Barrett DM. Artificial urethral sphincter for incontinence. Urology. 2000; 56(3):353-359. 
38. Rosen HR, Urbarz C, Holzer B, et al. Sacral nerve stimulation as a treatment for fecal incontinence.  Gastroenterology. 2001; 121(3):536-541.
39. 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. 
40. Schmidt RA, Jonas U, Oleson KA, et al. Sacral nerve stimulation for the treatment of refractory urinary urge incontinence. J Urol. 1999; 162(2):352-357. 
41. Shaker HS, Hassouna MM. Sacral root neuromodulation in idiopathic nonobstructive chronic urinary retention. J Urol. 1998; 159(5):1476-1478.
42. Starkman JS, Scarpero H, Dmochowski RR. Emerging periurethral bulking agents for female stress urinary incontinence: is new necessarily better? Curr Urol Rep. 2006; 7(5):405-413.
43. Sung MS, Hong JY, Choi YH, et al. FES-biofeedback versus intensive pelvic floor muscle exercise for the prevention and treatment of genuine stress incontinence. J Korean Med Sci. 2000; 15(3):303-308. 
44. 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.
45. Tamanini JT, D’Ancona CA, Netto NR Jr. Treatment of intrinsic sphincter deficiency using the macroplastique implantation system: two-year follow-up. J Endourol. 2004; 18(9):906-911.
46. Van Balken MR, Vergunst H, Bemelmans BL. Prognostic factors for successful percutaneous tibial nerve stimulation. Eur Urol. 2006; 49(2):360-365.
47. Vandoninck V, van Balken MR, Finazzi AE, et al. Posterior tibial nerve stimulation in the treatment of voiding dysfunction: urodynamic data. Neurourol Urodyn. 2004; 23(3):246-251.
48. Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults. Cochrane Database Syst Rev. 2004; (1):CD001308. 
49. Walsh: Campbell’s Urology. 8th ed. St. Louis, MO. W.B. Saunders Co. 2002. pp 1070-1088.
50. Weatherall M. Biofeedback or pelvic floor muscle exercises for female genuine stress incontinence: a meta-analysis of trials identified in a systematic review. BJU Int. 1999; 83(9):1015-1016.
51. Yamanishi T, Yasuda K, Suda S, et al. Effect of functional continuous magnetic stimulation for urinary incontinence. J Urol. 2000; 163(2):456-459. 
52. Yaminishi, T, Yasuda K, Sakakibara R, et al. Randomized double-blind study of electrical stimulation for urinary incontinence due to detrusor overactivity. Urology. 2000; 55(3):353-357.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Blue Cross and Blue Shield Association. Biofeedback in the treatment of urinary incontinence in adults. TEC Assessment, 2000; 15(3).
2. Blue Cross and Blue Shield Association. Magnetic stimulation in the treatment of urinary incontinence in adults. TEC Assessment, 2000; 15(8). 
3. Blue Cross and Blue Shield Association. Pelvic floor electrical stimulation in the treatment of urinary incontinence in adults. TEC Assessment, 2000; 15(2).
4. Blue Cross and Blue Shield Association. Sacral Nerve Stimulation for the Treatment of Urge Incontinence. TEC Assessment, 1998; 13(18).
5. Blue Cross and Blue Shield Association. Sacral Nerve Stimulation for the Treatment of Urinary Urgency/Frequency in Adults. TEC Assessment, 2000; 15(7).
6. Centers for Medicare and Medicaid Services. National Coverage Determination for Biofeedback Therapy for the Treatment of Urinary Incontinence. NCD #30.1.1. Effective July 1, 2001. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on September 28, 2006.
7. Centers for Medicare and Medicaid Services. National Coverage Determination for Bladder Stimulators (Pacemakers). NCD #230.16. Effective October 7, 1996. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on September 28, 2006.
8. Centers for Medicare and Medicaid Services. National Coverage Determination for Incontinence Control Devices. NCD #230.10. Effective October 7, 1996.Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on September 28, 2006. 
9. Centers for Medicare and Medicaid Services. National Coverage Determination for Non-Implantable Pelvic Floor Electrical Stimulator. NCD #230.8. Effective June 19, 2006. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on September 28, 2006.
10. Centers for Medicare and Medicaid Services. National Coverage Determination for Sacral Nerve Stimulation for Urinary Incontinence. NCD #230.18. Effective January 1, 2002. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on September 28, 2006.
11. Hayes, Inc. Hayes Medical Technology Directory. Extracorporeal Magnetic Stimulation for Urinary Incontinence. Lansdale, PA: Hayes, Inc.; July 2003. Search updated May 1, 2005.
12. Hayes, Inc. Hayes Medical Technology Directory. Female Urinary Incontinence Treatment, Nonsurgical Devices. Lansdale, PA: Hayes, Inc.; May 2002. Search updated May 12, 2005. 
13. Hayes, Inc. Hayes Medical Technology Directory. Implantable Sacral Nerve Stimulation for Urinary Voiding Dysfunction. Lansdale, PA: Hayes, Inc.; April 2003. Search updated February 23, 2006. 
14. Hayes, Inc. Hayes Medical Technology Directory. Pelvic Floor Electrical Stimulation for the Treatment of Urinary Incontinence. Lansdale, PA: Hayes, Inc.; March 2006.
15. Hayes, Inc. Hayes Medical Technology Directory. Tension-Free Vaginal Tape Procedure for Treatment of Female Stress Urinary Incontinence. Lansdale, PA: Hayes, Inc.; February 2005. Search updated March 31, 2006.

Web Sites for Additional Information

1. American Urological Association. Clinical Practice Guideline. The Surgical Management of Female Stress Urinary Incontinence, 1997. Available at: http://www.auanet.org/guidelines/. Accessed on October 3, 2006.
2. Food and Drug Administration PMA Final Decisions Rendered for February 2005. New device trade name for Tegress™ Urethral Implant. Available at: http://www.fda.gov/cdrh/pma/pmafeb05.html. Accessed on October 24, 2006.
3. Food and Drug Administration (FDA): URYX® Urethral Bulking Agent. Available at:  http://www.fda.gov/cdrh/pdf3/p030030a.pdf. Accessed on March 16, 2006.
4. 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 October 3, 2006.
5. U.S. Food and Drug Administration New Device Approval. Macroplastique® Implants. P040050. Rockville, MD: FDA. October 30, 2006. Available at: http://www.fda.gov/cdrh/mda/docs/P040050.html. Accessed on January 21, 2007. 
6. U.S. Food and Drug Administration New Device Approval. Coaptite®. P040047. Rockville, MD: FDA. November 10, 2005. Available at: http://www.fda.gov/cdrh/mda/docs/p040047.html. Accessed on January 21, 2007.

Index

AMS Sphincter 8000 Urinary Prosthesis
Biofeedback for Urinary Incontinence
Bladder Stimulation
Coaptite®
Contigen®
Durasphere®
GYNECARE TVT SECUR System
Interstim®
Macroplastique®
NeoControl® Pelvic Floor Therapy System
Pelvic Muscle Exercises
Percutaneous Tibial Nerve Stimulation (PTNS)
Periurethral Injection of Bulking Agents
Pulsed Magnetic Neuromodulation
Renessa™
Sacral Nerve Stimulation for Urinary Incontinence
SURx
Tegress™ Urethral Implant Solution
Tension-Free Vaginal Tape (TVT)
Transurethral Radiofrequency Energy Collagen Micro-Remodeling
Transvaginal Radiofrequency
Urgent® PC Neuromodulation System
Urinary Incontinence Therapy, Adult
URYX®
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.

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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