CAM 139

Surgical and Minimally Invasive Treatments for Urinary Outlet Obstruction due to Benign Prostatic Hyperplasia (BPH)

Category:Surgery   Last Reviewed:February 2019
Department(s):Medical Affairs   Next Review:February 2020
Original Date:February 2016    

Description/Background
Urinary outlet obstruction is difficulty in the passage of urine from the bladder to the urethra caused by compression or resistance on the bladder outflow channel at any location from the bladder neck to the urethral meatus. In males, this can be caused by benign prostatic hyperplasia (BPH). BPH is a common age-related noncancerous condition in men that is characterized by an increase of epithelial and stromal cells in the periurethral area of the prostate. This increase in cells causes an enlargement of the prostate gland. This pathologic change is important because of the proximal anatomical relationship between the prostate and the bladder neck. The condition generally involves lower urinary tract symptoms (LUTS), which mayinclude increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying. Given the substantive symptomatic impact of urinary outlet obstruction, symptomatic appraisal of interference with activities of daily living is a crucial aspect of evaluation. In an effort to quantify the severity of symptomatic BPH, a urodynamic investigation (e.g., urine flow rate assessment) may be performed.

Treatment for BPH includes watchful waiting (e.g., active surveillance), medical management with pharmacotherapy (e.g., alpha-blockers, 5-alpha-reductase inhibitors), minimally invasive treatments (e.g., transurethral needle ablation [TUNA], transurethral microwave thermotherapy [TUMT]), and surgery (e.g., TURP, laser treatments). If there is minimal bother (i.e., interference with activities of daily living) and no evidence of prostate enlargement, watchful waiting may be utilized. Medical management may be indicated for individuals with uncomplicated BPH or moderate to severe symptoms, and individuals who are waiting for surgery, unwilling to undergo surgery, or are poor surgical candidates. Individuals with BPH who have complications such as acute urinary retention, recurrent urinary tract infections, hematuria, bladder stones, or renal insufficiency/failure due to BPH may be treated surgically. Untreated BPH may worsen over time and increase the risk of stones, infection, or kidney failure. The choice of treatment for urinary outlet obstruction due to BPH should be based on the individual's presentation and anatomy, the surgeon's level of training and experience, and a discussion of the potential benefit and risks for complications.

The primary goal of treatment is to alleviate bothersome symptoms (i.e., symptoms that interfere with activities of daily living) that result from prostatic enlargement. More recently, treatment has been focused on altering disease progression and preventing complications associated with BPH. Standard surgical treatments such as transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP) (in which an incision is made where the prostate meets the bladder), and open prostatectomy may be accompanied by undesirable complications such as blood loss, need for transfusion, salt imbalances from fluid absorption, and side effects such as incontinence and retrograde ejaculation. Newer surgical techniques that use lasers, as well as minimally invasive techniques that use various sources of energy such as heat, microwaves, radiofrequency, and ultrasound, have been developed.

SURGICAL TREATMENTS
STANDARD SURGICAL TREATMENTS
Transurethral resection of the prostate (TURP) is the standard treatment for BPH against which all treatments are measured. TURP involves removing the core of the prostate through the urethra using instruments and electrodissection. An electrified wire loop removes pieces of prostatic tissue and coagulated blood. TURP is performed under general or spinal anesthesia and requires a hospital stay. Other standard surgical options include TUIP and open prostatectomy.

THERMAL TREATMENT
Transurethral electrovaporization of the prostate (TUVP) vaporizes the enlarged prostate tissue, destroying it by coagulation and allowing it to slough away over several weeks. TUVP steams the tissue away using high heat, and dries out the tissue using lower heat. Advantages of TUVP have shown earlier post-treatment catheter removal and less bleeding-related complications when compared to TURP. Evidence in available published peer-reviewed literature demonstrates the safety and effectiveness of TUVP for the treatment of BPH (Poulakis 2004).

LASER TREATMENTS
These procedures involve a laser fiber that is passed into the prostatic channel under telescopic guidance. The laser is then used, through vaporization or ablation techniques, to destroy the obstructing portions of the prostate with heat. With laser vaporization, high instantaneous heat is created to vaporize or steam away prostate tissue. Lower laser energy is applied with laser ablation, which heats the tissue enough to dry it out and allows it to shrink and slough away with time. Various types of laser treatments include:

  • Visual laser ablation of the prostate (VLAP)
    VLAP delivers a laser energy that is focused, without direct contact with the prostate, on the enlarged prostatic tissue, and causes thermal injury or coagulation necrosis of the tissue. The primary mechanism of tissue destruction is coagulation rather than vaporization, and the coagulated tissue sloughs away over several weeks following VLAP. VLAP requires a post-treatment catheterization from several days to several weeks.
  • Interstitial laser coagulation (ILC)
    ILC utilizes a fiber-optic laser probe that is inserted through a cystoscope into the prostate at fixed points. Laser energy is applied to coagulate each area of obstructing prostate tissue, producing coagulation necrosis. In contrast to other laser procedures, where coagulation necrosis occurs at the urethral surface, in interstitial laser coagulation, delivery of laser energy directly into the tissues produces coagulation necrosis inside the enlarged prostatic tissue. The treated tissue is absorbed over a period of several weeks.
  • Transurethral ultrasound-guided laser-induced prostatectomy (TULIP)
    TULIP was one of the first laser treatments used for BPH. A laser probe is housed between two ultrasound transducers that are used for real-time scanning to position the laser while it is being used. Coagulation necrosis of the prostate tissue produces shrinking over several weeks following TULIP. TULIP has been replaced by other laser techniques that have fewer side effects, shorter post-treatment catheterization times, and fewer urinary symptoms.
  • Holmium laser
    Holmium laser treatments of the prostate are treatments that use a holmium laser fiber and a specially adapted resectoscope to ablate, resect, or enucleate enlarged prostatic tissue. Relief of obstruction is immediate. Holmium lasers are among the most common laser technologies used to treat prostate disease. With the holmium laser, there is the ability to coagulate tissue simultaneously with tissue incision, ablation, resection or enucleation. This reduces intraoperative blood loss as well as post-operative bleeding. The American Urological Association (AUA 2010) states that holmium laser treatments are appropriate and effective treatment alternatives to TURP and open prostatectomy in individuals with moderate to severe LUTS due to BPH, and/or who are significantly bothered by these symptoms (i.e., interfere with activities of daily living). Additionally, according to AUA, these treatments have been associated with shorter post-treatment catheterization time and shorter length of hospital stay.
    • Holmium laser ablation of the prostate (HoLAP)
      This technology delivers laser energy at a wavelength of infrared range which is primarily absorbed by water. HoLAP is intended to be comparable to TURP, in that the prostatic lobes may be vaporized down to a surgical capsule resulting in a TURP-like effect. HoLAP does not yield tissue for histologic analysis. A controlled trial reported that although HoLAP took longer to perform than TURP, LUTS due to BPH and physiological measures improved to a similar degree after HoLAP and TURP (Mottet 1999).
    • Holmium laser resection of the prostate (HoLRP)
      This technology utilizes a specially adapted resectoscope to resect prostate tissue into pieces small enough to be removed with bladder irrigation and grasping forceps or a modified resectoscope loop. Improvements in LUTS due to BPH obtained by using HoLRP are comparable to TURP (Gilling 1999, Ruzat 2008).
    • Holmium laser enucleation of the prostate (HoLEP)
      HoLEP is typically used for larger glands that previously would have been treated with an open prostatectomy. Here, an entire prostatic lobe can be separated from connective tissue and deposited in the bladder. The tissue is then extracted from the bladder. HoLEP has been evaluated in clinical trials and compared favorably with TURP in meta-analyses and system reviews (Kuntz 2002, Elzayat 2007, Naspro 2009, Burke 2010).
  • Photoselective vaporization (PVP)
    PVP uses a potasium-titanyl-phosphate (KTP) laser to vaporize prostate tissue. KTP laser wavelengths penetrate only 1 to 2 mm, and the vaporization process may help avoid the perioperative side effects such as tissue sloughing. Additional reported potential advantages of PVP include virtually bloodless tissue ablation, shorter length of hospital stay, and shorter post-treatment catheterization times. As compared with TURP, surgical treatment of high-risk populations such as individuals taking anticoagulants, may be possible with PVP (Burke 2010, Ruszat 2008). PVP is an appropriate and effective treatment alternative to TURP and open prostatectomy in men who have moderate to severe LUTS due to BPH and/or who are significantly bothered by the symptoms (i.e., interfere with activities of daily living).

MINIMALLY INVASIVE TREATMENTS
Although TURP is the most commonly used treatment option for BPH, minimally invasive treatments have been developed that utilize various sources of energy, such as heat, radiofrequency, ultrasound, and microwaves. Minimally invasive treatments available include the following:

  • Water-induced thermotherapy (WIT)
    During this minimally invasive treatment, heated water is circulated through a proprietary closed-loop catheter system to produce coagulative necrosis and secondary ablation of obstructing prostatic tissue. Thermal insulation of the catheter shaft along the penile, bulbous, and membranous urethra, as well as in the sphincter region, prevents unwanted incidental damage of tissue along the urinary tract. According to the Urologic Clinics of North America, along with a review of the available published peer-reviewed literature and clinical guidelines, there is insufficient evidence to support the use of WIT for the treatment of urinary outlet obstruction due to BPH.
  • Balloon dilation of the prostate
    This minimally invasive treatment utilizes a flexible balloon catheter, which is placed in the urethra at the level of the prostate above the external sphincter. The balloon is then inflated for a short time to distend the prostatic urethra. Currently, the AUA does not recommend the use of balloon dilation of the prostate. Furthermore, the safety and/or efficacy of this service cannot be established by review of the available published peer-reviewed literature.
  • Transurethral ethanol ablation (chemoablation) of the prostate (TEAP)
    This minimally invasive treatment involves injecting absolute ethanol transurethrally into the prostate tissue. The injected ethanol causes cells of the prostate to burst, killing the cells. The prostate shrinks as the necrosed cells are absorbed. Currently, the AUA does not recommend the use of transurethral ethanol ablation of the prostate. Furthermore, the safety and/or efficacy of this service cannot be established by review of the available published peer-reviewed literature.
  • High-intensity focused ultrasound (HIFU)
    This minimally invasive treatment uses targeted high-intensity ultrasound to create coagulation necrosis in the prostate tissue. In contrast to other treatments, the HIFU device is inserted rectally and does not contact the prostate or urethra. Post-treatment catheterization time ranges from a few days to over a week. The safety and/or efficacy of this service cannot be established by review of the available published peer-reviewed literature. Randomized controlled trials comparing HIFU to standard treatments for BPH have not been published. Furthermore, at this time, the AUA considers HIFU as investigational, with additional long-term studies being warranted.
  • Transurethral needle ablation (TUNA) of the prostate (also called transurethral radiofrequency needle ablation [RFNA])
    This minimally invasive treatment delivers selective thermal energy to the prostate using two 18-gauge needles at the end of a TUNA catheter. A lens inside the catheter is used to guide the placement of the catheter into the urethra, where the needles are advanced to cause heat-induced coagulation necrosis in the prostate parenchyma. The prostate shrinks as the necrosed cells are absorbed. AUA recommends the use of TUNA as an appropriate and effective treatment alternative for bothersome (i.e., interfere with activities of daily living), moderate, or severe LUTS due to BPH. TUNA has been compared favorably with TURP in clinical trials and meta-analysis (Bouza 2006, Boyle 2004, Hill 2004). Although the improvement of LUTS due to BPH does not reach the same level as TURP; fewer adverse events (e.g., incontinence, retrograde ejaculation) are demonstrated.
  • Transurethral microwave thermotherapy (TUMT)
    This minimally invasive treatment begins by introducing a coolant into the urethra through a transurethral probe, which cools the urethra, followed by a microwave emission that heats and ultimately ablates prostatic tissue. AUA recommends the use of TUMT as an appropriate and effective treatment alternative for bothersome (i.e., interfere with activities of daily living), moderate, or severe LUTS due to BPH (Hoffman 2007).
  • Prostatic Urethral Lift (UroLift ®)
    The UroLift ® system is a minimally invasive implant developed to treat LUTS related to urinary outflow obstruction secondary to BPH in men 50 years of age or older. In this procedure, permanent implants (made from common implantable materials: nitinol, stainless steel, and polyethylene terepthalate) are delivered trans-prostatically to retract the enlarged lateral lobes of the prostate. This procedure dilates the prostatic urethra in individuals leading to improvement in LUTS symptoms without the need for surgical resection or the application of thermal energy to the prostate. Current evidence for this intervention includes 1 randomized sham-controlled trial (n = 206) published by Roehrborn et al. (2013), which found that at 12-month follow-up, both objective and subjective outcomes were significantly improved in individuals undergoing the UroLift procedure with no adverse impact to sexual function reported among any of the participants. An RCT directly comparing UroLift to TURP is scheduled for completion in December 2015. 

Regulatory Status
The use of devices in the minimally invasive treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH) should be in accordance with all of the FDA-approved labeling requirements and/or criteria.

Policy
The surgical and minimally invasive treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH) is considered MEDICALLY NECESSARY and, therefore, covered when all of the following criteria are met:

  • One of the following surgical or minimally invasive treatments is utilized:
    • Transurethral Resection of the Prostate (TURP)
    • Holmium laser ablation of the prostate [HoLAP])
    • Holmium laser enucleation of the prostate [HoLEP]
    • Holmium laser resection of the prostate [(HoLRP]
    • Photoselective vaporization (PVP)
    • Transurethral electrovaporization of the prostate (TUVP)
    • Transurethral needle ablation (TUNA)
    • Transurethral microwave thermotherapy (TUMT)
    • Interstitial laser coagulation of the prostate (ILCP)
    • Contact laser ablation of the prostate (CLAP)
    • Transurethral ultrasound-guided laser induced prostatectomy (TULIP)
    • Visually-guided laser ablation of the prostate (VLAP, also called non-contact laser ablation of the prostate)
    • Transurethral incision of the prostate (TUIP)
    • Ultrasonic aspiration
  • The individual has a diagnosis of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) (e.g., increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying) that interfere with activities of daily living.
  • The individual has a prostate-specific antigen (PSA) blood test that meets both of the following criteria:
    • Given within 12 months of the procedure
    • Resulted in a value of 2.5 ng/mL or less for individuals who are up to and including 60 years of age and 4.0 ng/mL or less for individuals who are over 60 years of age
  • The individual has a peak urine flow rate (Qmax) less than 15 cc/sec on a voided volume that is greater than 125 cc.
  • The individual has failed a trial of satisfactory voiding with medication (alpha blocker and/or alpha-reductase inhibitor) or intolerance to medication (alpha blocker and/or 5-alpha-reductase inhibitor).
  • In addition to the above criteria, if the individual has a diagnosis or history of prostate cancer and meets either of the following criteria:
    • The individual is not a candidate for surgical resection of the prostate but will be treated by radiation therapy and has symptoms that are so severe that immediate relief is required.
    • The individual is clinically in remission as evidenced by a PSA < 1.0 ng/mL.

UroLift for the treatment of urinary outlet obstruction due to BPH is considered MEDICALLY NECESSARY and, therefore, is covered if the following criteria are met:

  • The individual has a diagnosis of LUTS secondary to BPH (e.g., increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying) that interfere with activities of daily living.
  • The individual has a peak urine flow rate (Qmax) less than 15 cc/sec on a voided volume that is greater than 125 cc.
  • The individual's symptoms are caused by enlargement of the lateral lobes of the prostate with no median lobe enlargement present.
  • The individual has normal renal function.
  • The individual has mild to moderate symptoms that are refractory to medication or the individual does not wish to take daily medication.
  • The individual is a poor candidate for other surgical interventions for BPH, or the individual opts to undergo a minimally-invasive procedure.
  • The individual has a PSA blood test that meets both of the following criteria:
    • Given within 12 months of the procedure
    • Resulted in a value of 2.5 ng/mL or less for individuals who are up to and including 60 years of age and 4.0 ng/mL or less for individuals who are over 60 years of age
  • In addition to the above criteria, if the individual has a diagnosis or history of prostate cancer and meets either of the following criteria:
    • The individual is not a candidate for surgical resection of the prostate but will be treated by radiation therapy and has symptoms that are so severe that immediate relief is required.
    • The individual is clinically in remission as evidenced by a PSA < 1.0 ng/mL.

The use of the above procedures to treat conditions other than those described above is considered NOT MEDICALLY NECESSARY and, therefore, is not covered because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of other conditions.

The following procedures are considered INVESTIGATIONAL and, therefore, not covered because their safety and/or effectiveness in the treatment of urinary outlet obstruction due to BPH has not been established by review of the available published peer-reviewed literature this list may not be all inclusive:

  • Balloon dilation of the prostate
  • Transurethral ethanol ablation of the prostate (TEAP)
  • High-intensity focused ultrasound (HIFU)
  • Water-indcued thermotherapy (also known as hot-water balloon thermoablation and thermourethral hot-water therapy)   

Policy Guidelines 
Serum prostate-specific antigen (PSA) level and prostate size should not be used as the sole basis of treatment recommendations.  

Benefit Application
Bluecard/National Account Issues 
Subject to the terms and conditions of the applicable benefit contract, surgical and minimally invasive treatments for urinary outlet obstruction due to BPH are covered under the medical benefits of the Company’s products when medical necessity criteria listed in the medical policy are met. 

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  67. National Institute for Clinical Excellence (NICE). KTP laser (60-80W) vaporisation of the prostate. Interventional Procedure Consultation Document. London, UK: NICE; June 2003. Available at: http://www.nice.org.uk/article.asp?a=91073. Accessed January 2004.
  68. Klingler HC. New innovative therapies for benign prostatic hyperplasia: Any advance? Curr Opin Urol. 2003;13(1):11-15.
  69. American Urologic Association (AUA), Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J Urol. 2003;170(2 Pt 1):530-547.
  70. Tooher, RL, Scott A, Maddern G, et al. A systematic review of holmium laser prostatectomy. ASERNIP-S Report No.23. Adelaide, SA: Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S); June 2003.
  71. National Institute for Clinical Excellence (NICE). Transurethral electrovaporisation of the prostate.  Interventional Procedure Guidance 14. London, UK: NICE; October 2003. Available at: http://www.nice.org.uk/cms/htm/default/en/IP_112/ipg014guidance/docref.aspx. Accessed February 5, 2004.
  72. National Institute for Clinical Excellence (NICE). Transurethral radiofrequency needle ablation of the prostate. Interventional Procedure Guidance 15. London, UK: NICE; October 2003. Available at: http://www.nice.org.uk/cms/htm/default/en/IP_113/ipg015guidance/docref.aspx. Accessed February 5, 2004.
  73. Ogiste JS, Cooper K, Kaplan SA. Are stents still a useful therapy for benign prostatic hyperplasia? Curr Opin Urol. 2003;13(1):51-57.
  74. Corica AP, Larson BT, Sagaz A, et al. A novel temporary prostatic stent for the relief of prostatic urethral obstruction. BJU Int. 2004;93(3):346-348.
  75. Henderson A, Laing RW, Langley SE. A Spanner in the works: The use of a new temporary urethral stent to relieve bladder outflow obstruction after prostate brachytherapy. Brachytherapy. 2002;1(4):211-218.
  76. Isotalo T, Talja M, valimma T, et al. A bioabsorbable self-expandable, self-reinforced poly-L-lactic acid urethral stent for recurrent urethral strictures: Long-term results. J Endourol. 2002;16(10):759-762.
  77. Finnish Medical Society Duodecim. Benign prostatic hyperplasia. In: EBM Guidelines. Evidence-Based Medicine [CD-ROM]. Helsinki, Finland: Duodecim Medical Publications Ltd.; April 10, 2004.
  78. van Dijk MM, de la Rosette J. Prostatic stents in the treatment of benign prostatic hyperplasia.  Business Briefing: Global Surgery. 2003:1-6.
  79. Pizzoccaro M, Cantanzaro M, Stubinski R, et al. [The use of temporary stents in the treatment of urethral stenosis]. Arch Ital Urol Androl. 2002;74(3):111-112.
  80. Azuma H, Chancellor MB. Overview of biodegradable urethral stents. Rev Urol. 2004;6(2))98-99.
  81. Tammela TL, Talja M. Biodegradable urethral stents. BJU Int. 2003;92:843-850.
  82. AbbeyMoor Medical, Inc. The Spanner Prostatic Stent [website]. Miltona, MN: AbbeyMoor Medical; 2004. Available at: http://www.abbeymoormedical.com/. Accessed October 22, 2004.
  83. Hoffman RM, MacDonald R, Wilt TJ. Laser prostatectomy for benign prostatic obstruction. Cochrane Database Syst Rev. 2000;(1):CD001987.
  84. California Technology Assessment Forum (CTAF). Water-induced thermotherapy for benign prostatic hyperplasia. San Francisco, CA: CTAF; February 13, 2002. Available at: http://ctaf.org/ass/viewfull.ctaf?id=6048341339. Accessed March 23, 2005.
  85. National Institute for Health and Clinical Excellence (NICE). Potassium-titanyl-phosphate (KTP) laser vaporisation of the prostate for benign prostatic obstruction. Interventional Procedure Guidance 120. London, UK: NICE; May 2005.
  86. Naspro R, Salonia A, Colombo R, et al. Update of the minimally invasive therapies for benign prostatic hyperplasia. Curr Opin Urol. 2005;15(1):49-53.
  87. Tan AH, Gilling PJ. Lasers in the treatment of benign prostatic hyperplasia: An update. Curr Opin Urol. 2005;15(1):55-58.
  88. Webber R. Benign prostatic hyperplasia. In: Clinical Evidence. London, UK: BMJ Publishg Group; May 2004.
  89. National Institute for Health and Clinical Excellence (NICE). Transurethral electrovaporisation of the prostate, guidance. Interventional Procedure Guidance 14. London, UK: NICE; October 2003. Available at: http://www.nice.org.uk/page.aspx?o=ipg014guidance. Accessed January 26, 2007.
  90. Nuhoglu B, Ayyildiz A, Fidan V, et al. Transurethral electrovaporization of the prostate: Is it any better than standard transurethral prostatectomy? 5-year follow-up. J Endourol. 2005;19(1):79-82.
  91. Fowler C, McAllister W, Plail R, et al. Randomsed evaluation of alternative electrosurgical modalities to treat bladder outflow obstruction in men with benign prostatic hyperplasia. Health Tech Assess. 2005;9(4):iii-iv, 1-30. Available at: http://www.hta.ac.uk/execsumm/summ904.htm. Accessed January 26, 2007.
  92. Thomas CA, Chuang YC, Giannantoni A, Chancellor MB. Botulinum A toxin for the treatment of benign prostatic hyperplasia/lower urinary tract symptoms. Curr Urol Rep. 2006;7(4):266-271.
  93. Azzouzi AR, Fourmarier M, Desgrandchamps F, et al. Other therapies for BPH patients: Desmopressin, anti-cholinergic, anti-inflammatory drugs, and botulinum toxin. World J Urol. 2006;24(4):383-388.
  94. Chuang YC, Chancellor MB. The application of botulinum toxin in the prostate. J Urol. 2006;176(6 Pt 1):2375-2382.
  95. Armitage JN, Rashidian A, Cathcart PJ, et al. The thermo-expandable metallic stent for managing benign prostatic hyperplasia: A systematic review. BJU Int. 2006;98(4):806-810.
  96. Ontario Ministry of Health and Long-Term Care, Medical Advisory Secretariat (MAS).  Energy delivery systems for treatment of benign prostatic hyperplasia: Health Technology Policy Assessment. Toronto, ON: MAS; August 2006.
  97. Murtagh J, Foerster V. Photoselective vaporization for benign prostatic hyperplasia. Issues in Emerging Health Technologies Issue 95. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); 2006.
  98. Fried NM. New laser treatment approaches for benign prostatic hyperplasia. Curr Urol Rep. 2007;8(1):47-52.
  99. Daehlin L, Frugård J. Interstitial laser coagulation in the management of lower urinary tract symptoms suggestive of bladder outlet obstruction from benign prostatic hyperplasia: Long-term follow-up. BJU Int. 2007;100(1):89-93..
  100. Vanderbrink BA, Rastinehad AR, Badlani GH. Prostatic stents for the treatment of benign prostatic hyperplasia. Curr Opin Urol. 2007;17(1):1-6.
  101. Armitage JN, Cathcart PJ, Rashidian A, et al. Epithelializing stent for benign prostatic hyperplasia: A systematic review of the literature. J Urol. 2007;177(5):1619-1624.  
  102. Plante MK, Marks LS, Anderson R, et al. Phase I/II examination of transurethral ethanol ablation of the prostate for the treatment of symptomatic benign prostatic hyperplasia. J Urol. 2007;177(3):1030-1035; discussion 1035.
  103. Hoffman RM, Monga M, Elliot SP, et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2007;(4):CD004135.
  104. National Institute for Health and Clinical Excellence (NICE). Laparoscopic prostatectomy for benign prostatic obstruction. Interventional Procedure Guidance 275. London, UK: NICE; November 2008.
  105. Kaye JD, Smith AD, Badlani GH, et al. High-energy transurethral thermotherapy with CoreTherm approaches transurethral prostate resection in outcome efficacy: A meta-analysis. J Endourol. 2008;22(4):713-718.
  106. O'Leary MP, Roehrborn CG, Black L. Dutasteride significantly improves quality of life measures in patients with enlarged prostate. Prostate Cancer Prostatic Dis. 2008;11(2):129-133.
  107. Lourenco T, Pickard R, Vale L, et al; Benign Prostatic Enlargement team. Alternative approaches to endoscopic ablation for benign enlargement of the prostate: Systematic review of randomised controlled trials. BMJ. 2008;337:a449.
  108. Lourenco T, Armstrong N, N'Dow J, et al. Systematic review and economic modelling of effectiveness and cost utility of surgical treatments for men with benign prostatic enlargement. Health Technol Assess. 2008;12(35):iii, ix-x, 1-146, 169-515.
  109. Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Non-drug local procedures in the treatment of benign prostatic hyperplasia. Executive Summary. IQWiG Reports - Commission No. N04-01. Cologne, Germany: IQWiG; 2008.
  110. Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Non-drug local procedures in the treatment of benign prostatic hyperplasia - update. Executive Summary. IQWiG Reports - Commission No. N09-01. Cologne, Germany: IQWiG; 2009.
  111. Paz-Valinas L. Photoselective vaporization for benign prostatic hyperplasia with KTP (potassium-titanyl-phosphate) laser or GreenLight [summary]. CT2007/04. Santiago de ComPostela. Spain: Galician Agency for Health Technology Assessment (AVALIA-T); December 2007.
  112. Paz-Valinas L, Atienza G. Holmium laser enucleation of benign prostatic hyperplasia [summary]. CT2009/01. Santiago de ComPostela, Spain: Galician Agency for Health Technology Assessment (AVALIA-T); March 2009.
  113. Ruszat R, Wyler SF, Seitz M, et al. Comparison of potassium-titanyl-phosphate laser vaporization of the prostate and transurethral resection of the prostate: Update of a prospective non-randomized two-centre study. BJU Int. 2008;102(10):1432-1438; discussion 1438-1439.
  114. Richter M, Schwarz J, De Geeter P, Albers P. Holmium laser ablation of the prostate. An alternative to GreenLight photoselective vaporization of the prostate. Urologe A. 2009;48(3):291-295.
  115. Erol A, Cam K, Tekin A, et al. High power diode laser vaporization of the prostate: Preliminary results for benign prostatic hyperplasia. J Urol. 2009;182(3):1078-1082.
  116. Van Cleynenbreugel B, Srirangam SJ, Van Poppel H. High-performance system GreenLight laser: Indications and outcomes. Curr Opin Urol. 2009;19(1):33-37.
  117. Naspro R, Bachmann A, Gilling P, et al. A review of the recent evidence (2006-2008) for 532-nm photoselective laser vaporisation and holmium laser enucleation of the prostate. Eur Urol. 2009;55(6):1345-1357.
  118. Chung DE, Te AE. New techniques for laser prostatectomy: An update. Therapeut Advances Urol. 2009;1(2):85-97.
  119. Elmansy HM, Elzayat E, Elhilali MM. Holmium laser ablation versus photoselective vaporization of prostate less than 60 cc: Long-term results of a randomized trial. J Urol. 2010;184(5):2023-2028.
  120. Oeconomou A, Madersbacher H. Botulinum neurotoxin A for benign prostatic hyperplasia. Curr Opin Urol. 2010;20(1):28-36.
  121. Hashim H, Abrams P. Emerging drugs for the treatment of benign prostatic obstruction. Expert Opin Emerg Drugs. 2010;15(2):159-174.
  122. Wang C. Phosphodiesterase-5 inhibitors and benign prostatic hyperplasia. Curr Opin Urol. 2010;20(1):49-54.
  123. Andersson KE, de Groat WC, McVary KT, et al. Tadalafil for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: Pathophysiology and mechanism(s) of action. Neurourol Urodyn. 2011;30(3):292-301.
  124. Food and Drug Administration. FDA approves Cialis to treat benign prostatic hyperplasia. October 6, 2011. FDA: Silver Spring, MD. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274642.htm. Accessed January 12, 2012.
  125. Gravas S, Bachmann A, Reich O, et al. Critical review of lasers in benign prostatic hyperplasia (BPH). BJU Int. 2011;107(7):1030-1043.
  126. Herrmann TR, Liatsikos EN, Nagele U, et al; EAU Guidelines Panel on Lasers, Technologies. EAU guidelines on laser technologies. Eur Urol. 2012;61(4):783-795.
  127. Chin PT, Bolton DM, Jack G, et al. Prostatic urethral lift: Two-year results after treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urology. 2012;79(1):5-11.
  128. Barkin J, Giddens J, Incze P, et al. UroLift system for relief of prostate obstruction under local anesthesia. Can J Urol. 2012;19(2):6217-6222.
  129. Roehrborn CG, Gange SN, Shore ND, et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: The L.I.f.T. Study. J Urol. 2013;190(6):2161-2167.
  130. U.S. Food and Drug Administration (FDA). New medical device treats urinary symptoms related to enlarged prostate. FDA News. Silver Spring, MD: FDA; September 13, 2013. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368325.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 13, 2013.
  131. Pisco JM, Pinheiro LC, Bilhim T, et al. Prostatic arterial embolization to treat benign prostatic hyperplasia. J Vasc Interv Radiol. 2011;22(1):11-19; quiz 20.
  132. Fernandes L, Rio Tinto H, Pereira J, et al. Prostatic arterial embolization: Post-procedural follow-up. Tech Vasc Interv Radiol. 2012;15(4):294-299.
  133. Pisco J, Campos Pinheiro L, Bilhim T, et al. Prostatic arterial embolization for benign prostatic hyperplasia: Short- and intermediate-term results. Radiology. 2013;266(2):668-677.
  134. McNicholas TA, Woo HH, Chin PT, et al. Minimally invasive prostatic urethral lift: Surgical technique and multinational experience. Eur Urol. 2013;64(2):292-299.
  135. McVary KT, Gange SN, Shore ND, et al; L.I.F.T. Study Investigators. Treatment of LUTS secondary to BPH while preserving sexual function: Randomized controlled study of prostatic urethral lift. J Sex Med. 2014;11(1):279-287.
  136. National Institute for Health and Clinical Excellence (NICE). Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. Interventional Procedure Guidance 475. London, UK: NICE; January 2014.
  137. Cantwell AL, Bogache WK, Richardson SF, et al. Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. BJU Int. 2014;113(4):615-622.
  138. Chughtai B, Dunphy C, Lee R, et al. Randomized, double-blind, placebo controlled pilot study of intradetrusor injections of onabotulinumtoxinA for the treatment of refractory overactive bladder persisting following surgical management of benign prostatic hyperplasia. Can J Urol. 2014;21(2):7217-7221.
  139. Bagla S, Martin CP, van Breda A, et al. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia. J Vasc Interv Radiol. 2014;25(1):47-52.
  140. Russo A, La Croce G, Capogrosso P, et al. Latest pharmacotherapy options for benign prostatic hyperplasia. Expert Opin Pharmacother. 2014;15(16):2319-2328.
  141. Leoci R, Aiudi G, Silvestre F, et al. Effect of pulsed electromagnetic field therapy on prostate volume and vascularity in the treatment of benign prostatic hyperplasia: A pilot study in a canine model. Prostate. 2014;74(11):1132-1141.
  142. Grosso M, Balderi A, Arno M, et al. Prostatic artery embolization in benign prostatic hyperplasia: Preliminary results in 13 patients. Radiol Med. 2015;120(4):361-368.
  143. Faber K, Castro de Abreu AL, Ramos P, et al. Image-guided robot-assisted prostate ablation using water jet-hydrodissection: Initial study of a novel technology for benign prostatic hyperplasia. J Endourol. 2015;29(1):63-69.
  144. Talja M, Tammela T, Petas A, et al. Biodegradable self-reinforced polyglycolic acid spiral stent in prevention of postoperative urinary retention after visual laser ablation of the prostate-laser prostatectomy. J Urol. 1995;154(6):2089-2092.
  145. Petas A, Talja M, Tammela T, et al. A randomized study to compare biodegradable self-reinforced polyglycolic acid spiral stents to suprapubic and indwelling catheters after visual laser ablation of the prostate. J Urol. 1997;157(1):173-176.
  146. Devonec M, Dahlstrand C. Temporary urethral stenting after high-energy transurethral microwave thermotherapy of the prostate. World J Urol. 1998;16(2):120-123.
  147. Djavan B, Fakhari M, Shariat S, et al. A novel intraurethral prostatic bridge catheter for prevention of temporary prostatic obstruction following high energy transurethral microwave thermotherapy in patients with benign prostatic hyperplasia. J Urol. 1999a;161(1):144-151.
  148. Djavan B, Ghawidel K, Basharkhah A, et al. Temporary intraurethral prostatic bridge-catheter compared with neoadjuvant and adjuvant alpha-blockade to improve early results of high-energy transurethral microwave thermotherapy. Urology. 1999b;54(1):73-80.
  149. Petas A, Isotalo T, Talja M, et al. A randomised study to evaluate the efficacy of a biodegradable stent in the prevention of postoperative urinary retention after interstitial laser coagulation of the prostate. Scand J Urol Nephrol. 2000;34(4):262-266.
  150. Shore ND, Dineen MK, Saslawsky MJ, et al. A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. J Urol. 2007;177(3):1040-1046.
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  152. Geavlete B, Stanescu F, Iacoboaie C, Geavlete P. Bipolar plasma enucleation of the prostate vs open prostatectomy in large benign prostatic hyperplasia cases -- a medium term, prospective, randomized comparison. BJU Int. 2013;111(5):793-803.
  153. Koca O, Keles MO, Kaya C, et al. Plasmakinetic vaporization versus transurethral resection of the prostate: Six-year results. Turk J Urol. 2014;40(3):134-137.
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Coding Section 

Code Number Description
CPT 52441 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant, single implant
  52442 Each additional permanent adjustable transprostatic implant (List separately in addition to code for primary procedure)
  52601 Transurethral electrosurgical resection of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation and internal urethrotomy are included)
  52630 Transurethral resection; residual or regrowth of obstructive prostate tissue including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation and internal urethrotomy are included)
  52647 Non-contact laser coagulation of prostate (code descriptor revised 1/1/06 - Laser coagulation of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation and internal urethrotomy are included if performed) 
  52648 Contact laser vaporization of prostate (code descriptor revised 1/1/06 – Laser vaporization of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)
  52649 Prostate laser enucleation
  53850

Transurethral destruction of prostate tissue; by microwave thermotherapy

  53852

Transurethral destruction of prostate tissue; by Radiofrequency thermotherapy

  53854 (effective 01/01/2019)

by radiofrequency generated water vapor thermotherapy  

  53899 Unlisted procedure, urinary system
HCPCS C9739 Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants
  C9740 Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants
  C9747 (effective 7/1/2017)  Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance. 
ICD-9 Dignosis 185 Malignant neoplasm of prostate
  600.01 Hypertrophy (benign) of prostate with urinary obstruction and other lower urinary tract symptoms (LUTS)
  600.11 Nodular prostate with urinary obstruction
  600.21 Benign localized hyperplasia of prostate with urinary obstruction and other lower urinary tract symptoms (LUTS)
  600.91 Hyperplasia of prostate, unspecified with urinary obstruction
  V10.46 Personal history of malignant neoplasm of prostate
ICD-10-CM C61 Malignant neoplasm of prostate
  N40.1 Enlarged prostate with lower urinary tract symptoms
  N40.3 Nodular prostate with lower urinary tract symptoms
  Z85.46 Personal history of malignant neoplasm of prostate
ICD-9 Procedure   No Codes
ICD-10-PCS   No Codes

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2016 Forward     

01/31/2019 

Annual review, no change to policy intent. 

11/27/2018 

Updated policy with 2019 coding. No other changes made.

03/13/2018 

Annual review, updating procedures to indicate ILCP, CLAP, TULIP, VLAP, TUIP and ultrasonic aspiration may be considered medically necessary if criteria are met. Categorizing water induced thermotherapy as investigational. Limited update to description/background. Also updating references. 

05/22/2017 

Interim Review. Updated coding section 

02/06/2017 

Annual review, no change to policy intent. 

05/25/2016 

Corrected coding for CPT code 53852.

02/09/2016

NEW POLICY

 


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