This document addresses the following treatments for urinary incontinence:

• Vaginal weight training;
• Injection of periurethral bulking agents;
• Transvaginal radiofrequency bladder neck suspension, and;
• Transurethral radiofrequency energy collagen micro-remodeling.

Note: Please see the following related document(s) for additional information:

• CG-SURG-08 Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury
• DRUG.00006 Botulinum Toxin
• SURG.00117 Sacral Nerve Stimulation (SNS) and Percutaneous Tibial Nerve Stimulation (PTNS) for Urinary and Fecal Incontinence; Urinary Retention

Medically Necessary:

• Injection of periurethral bulking agents is considered medically necessary when one or more of the following are met:
  • The individual has stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency (ISD) which persists despite at least 12 consecutive months of conventional therapy (e.g., exercise, medication); or
  • Post-traumatic or post-surgical injury; or
  • Urethral hypermobility in females with abdominal leak point less than 100 cm H₂0 which persists despite at least 12 consecutive months of conventional therapy (e.g., exercise, medication).

Investigational and Not Medically Necessary:

The following services are considered investigational and not medically necessary:

• Vaginal weight training with specially designed weights (cones) in all cases;
• The injection of periurethral bulking agents for individuals who do not meet the medically necessary criteria;
• Transvaginal radiofrequency bladder neck suspension as a treatment of urinary stress incontinence;
• Transurethral radiofrequency energy collagen micro-remodeling as a treatment of stress urinary incontinence.

Periurethral Bulking Agents
Periurethral injections of bulking agents such as cross-linked collagen (e.g., Contigen^®), carbon-coated beads (e.g., Durasphere^®), calcium hydroxylapatite (e.g., Coaptite^®) and polydimethylsiloxane (e.g., Macroplastique^®) have been studied in randomized trials that established safety and efficacy and are approved by the US Food and Drug Administration (FDA).

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.

Transvaginal Radiofrequency Bladder Neck Suspension (SURx Transvaginal System^® SURx, Inc., Livermore, California).
The minimal published literature regarding transvaginal radiofrequency bladder neck suspension is inadequate to permit scientific conclusions regarding the safety and long-term efficacy of these procedures. Dmochowski and colleagues (2003) reported on a multi-institutional prospective case series of 120 consecutive women with urinary stress incontinence who underwent transvaginal bladder neck suspension. Enrolled subjects had failed at least a 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 participant 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 the participants were considered cured or improved at 12 months. More than 68% of the participants 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.

Transurethral Radiofrequency Energy Collagen Micro-Remodeling (Renessa™ System Novasys Medical, Inc., Newark, CA).
Transurethral radiofrequency energy collagen micro-remodeling is being investigated as a non-surgical treatment for women with stress urinary incontinence (SUI). Elser and colleagues (2009) reported 12-month results from an ongoing prospective, 36-month, open-label, single-arm clinical trial to assess efficacy of nonsurgical transurethral collagen denaturation (Renessa) in women with stress urinary incontinence (SUI) caused by bladder outlet hypermobility. Objective metrics included voiding diaries and in-office stress pad weight tests. Subjective measures included the Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), and Global Impression of Improvement (PGI-I) instruments. Of the 136 women who were treated, 75 were available for 12 month follow-up. At 12 months, significant reductions existed from baseline in the median number of daily (–0.61) and weekly (–4.0) leaks caused by activity, and 50% of the subjects experienced at least 50% fewer leaks compared with baseline (52% of evaluable participants). So far, this study is limited by the large losses to follow-up.

Elser and colleagues (2010) also reported data at 18 months for this three year ongoing study. At this time, of the 136 women initially treated, clinical data for 60 were available. The data showed that incontinent episodes decreased while quality of life and participant satisfaction with the procedure increased. The authors noted, of all participants lost to follow up, 21 withdrew because of suboptimal results and from this group, 19 went on to have surgery. The authors stated that since this was a single arm observational study, the lack of predefined response criteria permitted subjective bias in the participant's perception and expectations for outcomes. Furthermore, it cannot be assumed that the attrition was due to dissatisfaction; some women may have discontinued because they were doing well and did not wish to remain in the study. The authors concluded that while transurethral collagen denaturation is a non surgical option for SUI, it does not eliminate the need for subsequent surgery and further study is needed.

Urinary voiding dysfunction is divided into two general categories—urinary incontinence (UI) which is the inability to hold urine in the bladder and urinary retention, which is the inability to pass urine out of the bladder. Both men and women can experience urinary voiding dysfunction. Many women experience some incontinence due to pregnancy and childbirth, menopause, and the structure of the female urinary tract. Urinary retention in women can be caused by bladder muscle failure or obstruction. Many men experience incontinence and retention along with prostate enlargement or after prostate surgery.

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

Vaginal weight training involves the use of small, specially designed weights ("cones") that a woman may place in the vagina and hold there, to strengthen the muscles in the pelvic area. Over time, increasingly heavier weights are used and this is thought to increase muscle strength. The vaginal cones are made from surgical grade stainless steel surrounded by a double welded plastic case. They are smooth with a plastic coated retrieval cord.

The SURx Transvaginal System, which 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.

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.

Bulking agent: Refers to a substance, such as collagen, which is injected near the urinary opening to help increase pressure at the opening and prevent involuntary loss of urine.

Detrusor instability: A bladder that contracts and empties out urine even though it is not full, or when the person does not intend to urinate.

Intrinsic sphincter deficiency (ISD): A poor or non-functioning urethral outlet muscle.

Mixed incontinence: A combination of urge and stress incontinence.

Overflow incontinence: The bladder overfills without causing a sensation to urinate.

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

Stress urinary incontinence (SUI): The leakage of urine during physical activities that increase pressure on the bladder.

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

Urinary urge incontinence: Leakage of urine when there is a strong urge to void.

Urinary urgency-frequency: An uncontrollable urge to urinate resulting in very frequent, small volumes.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary: 

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Appell RA.Transurethral collagen denaturation for women with stress urinary incontinence. Curr Urol Rep. 2008; 9(5):373-379.
2. Appell RA, Singh G, Klimberg IW, et al. Nonsurgical, radiofrequency collagen denaturation for stress urinary incontinence: retrospective 3-year evaluation. Expert Rev Med Devices. 2007; 4(4):455-461.
3. Appell RA, Juma S, Wells WG, et al. Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence. Neurourol Urodyn. 2006; 25(4):331-336.
4. Berghmans LC, Hendriks HJ, De Bie RA, et al. Conservative treatment of urge urinary incontinence in women: a systematic review of randomized clinical trials. BJU Int. 2000; 85(3):254-263.
5. Buchsbaum GM, McConville J, Korni R, Duecy EE. Outcome of transvaginal radiofrequency for treatment of women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18(3):263-265.
6. Cespedes RD. Collagen injection or artificial sphincter for postprostatectomy incontinence: collagen. Urology. 2000; 55(1):5-7.
7. Dmochowski RR, Avon M, Ross J, et al. Transvaginal radio frequency treatment of the endopelvic fascia: a prospective evaluation for the treatment of genuine stress urinary incontinence. J Urol. 2003; 169(3):1028-1032.
8. Elser DM, Mitchell GK, Miklos JR, et al.  Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 12-month results from a prospective long-term study. J Minim Invasive Gynecol. 2009; 16(1):56-62.
9. Elser DM, Mitchell GK, Miklos JR, et al.  Nonsurgical transurethral collagen denaturation for stress urinary incontinence in women: 18-month results from a prospective long-term study. Neurourol Urodyn. 2010; 29(8):1424-1428.
10. Holroyd-Leduc JM, Straus SE. Management of urinary incontinence in women: scientific review. JAMA. 2004; 291(8):986-995.
11. Lenihan J. Comparison of the quality of life after nonsurgical radiofrequency energy tissue micro-remodeling in premenopausal and postmenopausal women with moderate-to-severe stress urinary incontinence. Am J Obstet Gynecol. 2005; 192(6):1995-1998.
12. Lightner D, Calvosa C, Andersen R, et al. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere. Urology. 2001; 58(1):12-15.
13. MacDonald R, Fink HA, Huckabay C, et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int. 2007; 100(1):76-81.
14. Madjar S, Covington-Nichols C, Secrest CL. New periurethral bulking agent for stress urinary incontinence: modified technique and early results. J Urol. 2003; 170(6 Pt 1):2327-2329.
15. McGuire EJ, English SF. Periurethral collagen injection for male and female sphincteric incontinence: indications, techniques, and result. World J Urol. 1997; 15(5):306-309.
16. Pannek J, Brands FH, Senge T. Particle migration after transurethral injection of carbon coated beads for stress urinary incontinence. J Urol. 2001; 166(4):1350-1353.
17. 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.
18. Shamliyan TA, Kane RL, Wyman J et al. Systematic review: randomized, controlled trials of nonsurgical treatments for urinary incontinence in women. Ann Intern Med 2008; 148(6):459-73.
19. 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.
20. 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.
21. 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.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse (NGC). Guideline synthesis: Assessment and management of urinary incontinence in women. 2010. Available at:  http://www.guideline.gov/syntheses/synthesis.aspx?id=16411&search=urinary+incontinence. Accessed on June 23, 2011.
2. American College of Obstetricians and Gynecologists (ACOG). Urinary incontinence in women. ACOG practice bulletin number 63. 2005. Available at: http://www.guideline.gov/summary/summary.aspx?doc_id=10931&nbr=5711&ss=6&xl=999. Accessed on June 23, 2011.
3. The California Technology Assessment Forum (CTAF). Radiofrequency Micro-remodeling for the Treatment of Female Stress Urinary Incontinence. October 15, 2008. Available at: http://www.ctaf.org/content/assessment/detail/930 . Accessed on June 23, 2011.
4. 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_chapter_list.asp . Accessed on June 23, 2011.
5. Herbison P, Plevnik S, Mantle J. Weighted vaginal cones for urinary incontinence. Cochrane Database Syst Rev. 2002; (1):CD002114.
6. Hunter KF, Glazener CM, Moore KN. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2007; (2):CD001843.
7. Pickard R, Reaper J, Wyness L, et al. Periurethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2003; (2): CD003881.
8. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. Renessa™ Transurethral Radiofrequency System. 510(K) Summary. No. K042132. Rockville, MD: FDA  July 14, 2005. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K042132.pdf. Accessed on June 22, 2011.
9. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. SurX RF System. 510(K) Summary. No. K020952. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K020952 . Accessed on June 22, 2011.

1. National Kidney and Urologic Diseases Information Clearinghouse. Urinary Incontinence in Women. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/uiwomen/index.htm. Accessed on June 23, 2011.

Coaptite^®
Contigen^®
Durasphere^®
Macroplastique^®
Periurethral Injection of Bulking Agents
Renessa^™
SURx^®
Transurethral Radiofrequency Energy Collagen Micro-Remodeling
Transvaginal Radiofrequency
Urinary Incontinence Therapy, Adult
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.