BlueCross BlueShield of Tennessee Medical Policy Manual

Prostatic Urethral Lift

DESCRIPTION

The prostatic urethral lift procedure involves the insertion of one or more permanent implants into the prostate, which retract prostatic tissue and maintain an expanded urethral lumen.

Benign prostatic hyperplasia (BPH) is a common disorder among older men that results from hyperplastic nodules in the periurethral or transitional zone of the prostate. BPH prevalence increases with age and is present in more than 80% of men aged 70 to 79. The clinical manifestations of BPH include increased urinary frequency, urgency, nocturia, hesitancy, and weak stream. The urinary tract symptoms often progress with worsening hypertrophy and may lead to acute urinary retention, incontinence, renal insufficiency, and/or urinary tract infection.

Evaluation and management of BPH includes evaluation for other causes of lower urinary tract dysfunction (e.g., prostate cancer). Symptom severity determines the therapeutic approach. Therapies available include oral medications, surgical ablative procedures, or transurethral resection of the prostate (TURP).

POLICY

See also:  Cryosurgical Ablation for the Treatment of Prostate Tumors

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

One implantable transprostatic tissue retractor system has been cleared for marketing by the FDA (i.e., the NeoTract UroLift® System) through the 510(k) process. The evidence remains insufficient to determine the effects of the technology on health outcomes.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2016). Prostatic urethral lift (7.01.151). Retrieved September 28, 2016 from BlueWeb. (29 articles and/or guidelines reviewed)

Chin, P., Bolton, D., Jack, G., Rashid, P., Thavaseelan, J., Yu, R., et al. (2012). Prostatic urethral lift: two-year results after treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urology, 79 (1), 5-11. Abstract retrieved September 28, 2016 from PubMed database.

ECRI Institute. Emerging Technology Evidence Report. (2017, April). Implantable transprostatic tissue retractor system (UroLift) for treating benign prostate hyperplasia. Retrieved July 7, 2017 from ECRI Institute. (127 articles and/or guidelines reviewed)

Gratzke,C., Barber, N., Speakman, M., Berges, R., Weterauer, U., Greene, D., et al. (2017). Prostatic urethral lift vs transurethral resectin of the prostate: 2-year resuls of the BPH6 prospective, multicentre, randomized study. BJU International, 119 (5), 767-775. (Level 2 evidence)

McNicholas, T. A. (2016). Benign prostatic hyperplasia and new treatment options – a critical appraisal of the UroLift system. Medical Devices: Evidence and Research, 9, 115-123. (Level 2 evidence)

McNicholas, T. A., Woo, H. H., Chin, P. T., Bolton, D., Fernández, A. M., Sievert, K. D., et al. (2013). Minimally invasive prostatic urethral lift: surgical technique and multinational experience. European Urology, 64 (2), 292-299. Abstract retrieved September 28, 2016 from PubMed database.

National Institute for Health and Care Excellence. (2014, January). Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. Retrieved July 7, 2017 from http://www.nice.org.uk/guidance/ipg475.

National Institute for Health and Care Excellence. (2015, September). UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia. Retrieved October 23, 2015 from http://www.nice.org.uk/guidance/mtg26. 

Palmetto Government Benefit Administrators. (2017, April). LCD for minimally invasive treatment for benign prostatic hyperplasia involving prostatic urethral lift (Urolift®) (L36109). Retrieved July 7, 2017 from https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36109.

Perera, M., Roberts, M. J., Doi, S. A. & Bolton, D. (2015). Prostatic urethral lift improves urinary symptoms and flow while preserving sexual function for men with benign prostatic hyperplasia: a systemic review and meta-analysis. European Urology, 67 (4), 704-713. Abstract retrieved September 28, 2016 from PubMed database.

Roehrborn, C. G., Barkin, J., Gange, S. N., Shore, N. D., Giddens, J. L., Bolton, D.M., et al. (2017). Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Canadian Journal of Urology, 24 (3), 8802-8813. (Level 2 evidence)

Rukstalis, D., Rashid, P., Bogache, W., Tutrone, R., Barkin, J., Chin, P., et al. (2016). 24-month durability after crossover to the prostatic urethral lift from randomized, blinded sham. BJU International, 118, Suppl 3, 14-22. (Level 2 evidence)

Sánchez-Gómez, L. M., Polo-deSantos, M., Gómez-Sancha, F., & Luengo-Matos, S. (2015). Efficacy and safety of the UroLift® system for the treatment of benign prostate hyperplasia symptoms: systematic review. Actas Urologicas Espanolas, 39 (5), 311-319. Abstract retrieved September 28, 2016 from PubMed database.

Sønksen, J., Barber, N., Speakman, M., Berges, R., Wetterauer, U., Greene, D., et al. (2015). Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. European Journal of Urology, 68, 643-652. (Level 2 evidence)

U. S. Food and Drug Administration. (2013, December). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database. K133281. Retrieved October 23, 2015 from http://www.fda.gov.

Winifred S. Hayes, Inc. Health Technology Brief. (2016, July). UroLift System (NeoTract Inc.) for treatment of benign prostatic hyperplasia. Retrieved July 7, 2017 from www.Hayesinc.com/subscribers. (31 articles and/or guidelines reviewed)

Woo, H., Chin, P., McNicholas, T., Gill, H., Plante, M., Bruskewitz, R., et al. (2011). Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU International, 108, 82-88. (Level 4 evidence)

ORIGINAL EFFECTIVE DATE:  3/11/2016

MOST RECENT REVIEW DATE:  8/10/2017

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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