Bulking Agents for the Treatment of Urinary Stress Incontinence and Vesicoureteral Reflux

Section: Surgery
Effective Date: March 01, 2020
Revised Date: February 22, 2020
Last Reviewed: January 22, 2020

Description

Stress urinary incontinence can result from intrinsic sphincter deficiency (ISD). Periurethral bulking agent is a material that is injected around the urethra; this narrows the urethra, so leakage is less likely to occur.

Most commonly seen in children, vesicoureteral reflux (VUR) is the retrograde flow of urine from the bladder upward toward the kidney. Bulking agents can be injected into tissue around the ureteral orifices to minimize reflux.

Criteria

Urinary Stress Incontinence

The use of carbon-coated spheres, calcium hydroxylapatite, or polydimethylsiloxane may be considered medically necessary to treat stress urinary incontinence in individuals who have failed appropriate conservative therapy for at least three months.

Conservative therapy for stress urinary incontinence may include:

  • Pelvic floor muscle exercises (Kegel exercises); or
  • Behavioral changes, such as
    • Fluid management; or
    • Smoking cessation; or
    • Weight loss; or
    • Moderation of physical activities that provoke stress urinary incontinence.
  • Additional options may include:
    • Intravaginal estrogen therapy; or
    • Use of a pessary; or
    • Treatment of other underlying causes of stress incontinence in individuals amenable to these treatments.

Individuals who have a reoccurrence of stress-urinary incontinence following successful treatment with FDA approved periurethral bulking agent implants in the past (e.g., 6-12 months previously) may benefit from additional treatment sessions. Coverage of additional sessions may be considered medically necessary when supported by medical record documentation.

Individuals whose stress urinary incontinence does not improve with five (5) injection procedures (five (5) separate treatment sessions) are considered treatment failures. Therefore, any further treatment of stress urinary incontinence with a periurethral bulking agent is considered not medically necessary.

The use of any other periurethral bulking agent, including, but not limited to Teflon, autologous cellular therapy (e.g., myloblasts, muscle derived stem cells, adipose derived stem cells), autologous fat, and autologous ear chondrocytes to treat stress urinary incontinence is considered experimental/investigational and is therefore non-covered because the safety and and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

51715 L8606

The use of periurethral bulking agents to treat urge urinary incontinence is considered experimental/investigational and therefore, non-covered because the safety and and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Code

L8604

Vesicoureteral Reflux

Periureteral bulking agents such as dextranomer/hyaluronic acid (Deflux) may be considered medically necessary as a treatment of children with VUR grades II, III, or IV when medical therapy has failed, and surgical intervention is otherwise indicated.

The use of bulking agents is contraindicated in individuals with:

  • Non-functioning kidney(s); or
  • Hutch diverticula; or
  • Active voiding dysfunction; or
  • Ongoing urinary tract infection.

The use of periurethral bulking agents for VUR in other clinical situations is considered not medically necessary.

Procedure Code

52327 L8604

Diagnosis Codes

Covered diagnosis codes for 51715 and L8606

N36.42 N36.43 N39.3

Covered diagnosis codes for 52327 and L8604

N11.0 N13.70 N13.71 N13.72 N13.721 N13.722 N13.729
N13.73 N13.731 N13.732 N13.739

Professional Statements and Societal Positions Guidelines

Society of Obstetricians and Gynecologists of Canada – 2010

In 2010, the Society of Obstetricians and Gynecologists of Canada Urogynaecology Committee published a guideline on the evaluation and treatment of recurrent urinary incontinence after pelvic floor surgery. The guideline recommends that conservative management be used as first-line therapy. It also stated that individuals with significantly decreased urethral mobility may be managed with periurethral bulking agents as one of several treatment options.

 

National Institute for Health and Care Excellence – 2015

In 2013, the National Institute for Health and Care Excellence (NICE) amended its 2006 clinical guideline on urinary incontinence in women. The guideline now recommends considering intramural bulking agents (silicone, carbon-coated zirconium beads or hyaluronic acid/dextran copolymer) for the management of SUI if conservative management has failed. Women should be made aware that repeat injections may be needed to achieve efficacy and that efficacy diminishes with time and is inferior to that of synthetic tapes or autologous rectus fascial slings.

 

American College of Obstetricians and Gynecologists – 2016

In 2016, the American College of Obstetricians and Gynecologists updated its practice bulletin on urinary incontinence in women. The practice bulletin stated 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.

 

American Urological Association et al – 2017

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 individuals 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.

In 2017, the American Urological Association reviewed their guidelines and confirmed that endoscopic injection therapy for VUR is an option in the treatment of VUR. Success rates for open surgery are 98%, with few complications, compared to rates of 83% for endoscopic surgery; however, the higher success rates for open surgery are offset by the greater expense and the need for in-patient hospitalization. Postoperative urinary tract infections (UTIs) can occur with either treatment but are more likely to occur in individuals with a prior history of frequent UTIs. Following surgery, an ultrasound to confirm absence of obstruction is a standard of care. While an infrequent occurrence, urinary obstruction may be “clinically silent” and have severe consequences that could be readily corrected. Cystography is a recommendation after endoscopic surgery and an option after open surgery. Following reflux resolution (surgically or spontaneously) it is recommended that a planned follow-up, including assessment for infection, renal abnormalities, and overall health, be continued through adolescence.

Infants under one (1) year of age may not show clinical evidence of pyelonephritis as clearly as older children and they may have a greater risk of infection-related morbidity. It is therefore recommended that continuous antibiotic prophylaxis (CAP) be used in these children until more definitive studies suggest otherwise. Reflux resolution occurs in about 50% of these children within 24 months.

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