Medical Policy


Subject:Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) and Other Genitourinary Conditions
Policy #:  SURG.00028Current Effective Date:  04/16/2013
Status:ReviewedLast Review Date:  02/14/2013

Description/Scope

Multiple procedures have been developed to treat benign prostatic hyperplasia (BPH). This document addresses various surgical and minimally invasive procedures used in the treatment of BPH, and the use of these procedures for other genitourinary conditions.

Note: Please see the following related documents for additional information:

Position Statement

Medically Necessary:

The following surgical procedures are considered medically necessary as an alternative to open prostatectomy or transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH):

  1. Laser-based procedures that have received U.S. Food and Drug Administration (FDA) approval include, but are not limited to the following:
    • Contact laser ablation of the prostate (CLAP)
    • Holmium laser procedures, including Holmium laser ablation of the prostate (HoLAP), Holmium laser enucleation of the prostate (HoLEP), and Holmium laser resection of the prostate (HoLRP)
    • Interstitial laser coagulation of the prostate (ILCP)
    • Photoselective laser vaporization of the prostate (PVP)
    • Transurethral ultrasound guided laser induced prostatectomy (TULIP)
    • Visually guided laser ablation of the prostate (VLAP), also called non-contact laser ablation of the prostate
  2. Transurethral incision of the prostate (TUIP).
  3. Transurethral radiofrequency needle ablation (RFNA), also called transurethral needle ablation (TUNA).
  4. Transurethral vapor resection of the prostate (TUVRP), also called transurethral electrovaporization of the prostate (TUEVP, TUVAP, or TUEVAP), transurethral evaporation (TUEP), or transurethral vaporization of the prostate (TUVP, TVP).

The following minimally invasive procedures are considered medically necessary as an alternative to open prostatectomy or TURP for the treatment of BPH:

  1. Water-induced thermotherapy (WIT), also called thermourethral hot-water therapy.
  2. Transurethral microwave thermotherapy (TUMT).

Not Medically Necessary:

Endoscopic balloon dilation of the prostatic urethra for the treatment for BPH is considered not medically necessary.

Investigational and Not Medically Necessary:

High-intensity focused ultrasound (HIFU) ablation for the treatment for BPH is considered investigational and not medically necessary.

Cryosurgical ablation of the prostate for the treatment for BPH is considered investigational and not medically necessary.

Placement of temporary prostatic stents is considered investigational and not medically necessary for all indications, including, but not limited to treatment of BPH, following surgical treatment of BPH, prostate cancer, or radiation therapy.

The following procedures are considered investigational and not medically necessary for all genitourinary conditions other than BPH:

  1. Contact laser ablation of the prostate (CLAP).
  2. Holmium laser procedures of the prostate (HoLAP, HoLEP, HoLRP).
  3. Interstitial laser coagulation of the prostate (ILCP).
  4. Photoselective laser vaporization of the prostate (PVP).
  5. Transurethral microwave thermotherapy (TUMT).
  6. Transurethral radiofrequency needle ablation (RFNA), also called transurethral needle ablation (TUNA).
  7. Transurethral ultrasound guided laser induced prostatectomy (TULIP).
  8. Visually guided laser ablation of the prostate (VLAP), also called non-contact laser ablation of the prostate.
  9. Water-induced thermotherapy (WIT), also called thermourethral hot-water therapy.
Rationale

Standard surgical treatments for BPH are some of the most common therapies in medical practice but as a management option are typically performed in the operating room setting, require anesthesia, and may be associated with a greater risk for morbidity. Surgical treatments such as open prostatectomy and TURP may be accompanied by undesirable complications such as blood loss, need for transfusion and absorption of irrigation fluids, and in side effects such as retrograde ejaculation and incontinence. Newer surgical techniques have been developed using lasers, as well as minimally invasive techniques using various sources of energy including heat, microwaves, radiofrequency, and ultrasound. There are a number of outcome variables to examine in comparing these surgical and minimally invasive treatments to other major surgical procedures. "Traditionally, the gold standards have been an open prostatectomy (retropubic, suprapubic) for very large prostates or those with large bladder calculi and a monopolar transurethral resection of the prostate (TURP). For small prostates (less than 30 gm), the option for a transurethral incision of the prostate (TUIP) has been found to be associated with fewer complications but comparable efficacy" (AUA, 2010).

Laser-based prostatectomy procedures including potassium-titanyl-phosphate photovaporization (Al-Ansari, 2010; Araki, 2008; Elmansy, 2010; Rusvat, 2008, Stafinski, 2008, Tugcu, 2008) and other surgical and minimally invasive treatments including TUIP (Riehmann, 1995; Tkocz, 2002), TUMT, RFNA/TUNA (Bouza, 2006; Boyle, 2004; Hill, 2004; Hindley, 2001; Roehrborn, 1999), and TUVP (Poulakis, 2004; Ekengren, 2000; Van Melick, 2002 and 2003) have been established as useful and alternative procedures to TURP. Holmium laser procedures including HoLAP (Elmansy, 2010), HoLEP (Ahyai, 2007; Elzayat, 2007; Kuntz, 2008; Shah, 2007; Tan, 2007; Wilson, 2006) and HoLRP (Ruzat, 2008; Westenberg, 2004) have been evaluated in clinical trials and compared with TURP in meta-analyses and systematic reviews. The data in the peer-reviewed medical literature suggests that these procedures may provide improvement in BPH symptoms, voiding function, and urinary retention, in addition to comparing favorably in the long-term to TURP with equally low complication rates. Although there is a lack of data directly comparing WIT with either TURP or other surgical procedures, the safety and efficacy of WIT has been shown to relieve the symptoms of BPH without the occurrence of blood loss, incontinence, and impotence which are sometimes associated with TURP (Breda, 2002; Muschter, 2000). 

TUMT (CoreTherm®, Prostalund® AB, Uppsala, Sweden; Prolieve Thermodilatation® System, Boston Scientific Corp. U.S.A, Natick, MA; Prostatron® and Targis® Systems, Cooled ThermoTherapy™, Urologix®, Minneapolis, MN; TMx-2000™-TherMatrx®, American Medical Systems, Inc., Minnetonka, MN) is another effective alternative treatment to TURP for BPH (Albala, 2002; Dahlstrand, 1995; Wagrell, 2004). Several randomized controlled and comparative trials have demonstrated that TUMT has similar efficacy as TURP in symptom relief and satisfaction (Albala, 2002; Floratos, 2001; Hoffman, 2012; Kaplan, 2004; Kaye, 2008; Miller, 2003; Mynderse, 2011; Norby, 2002; Ohigashi, 2007; Pace, 2001; Vesely, 2005).

The efficacy of these procedures has not been established as treatment in individuals with prostatic or other genitourinary conditions other than BPH. The American Urological Association's Guideline for the Management of Clinically Localized Prostate Cancer (AUA, 2010), the National Cancer Institute's Prostate Cancer Treatment (PDQ®) (NCI, 2012), and the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines inOncology-Prostate Cancer (NCCN, 2012) do not address these procedures as a treatment option for prostate carcinoma and related conditions. The level of evidence supporting the use of the technologies mentioned for conditions other than BPH is insufficient to draw conclusions regarding safety and efficacy. Further studies are needed before they can be considered a standard method of treatment for any condition other than BPH.

The AUA's updated Guideline on the Management of Benign Prostatic Hyperplasia (BPH) excludes a number of procedures from consideration in their treatment outcome analysis as there is insufficient and inadequate evidence available to make a recommendation for these procedures as a treatment alternative for an individual with moderate to severe symptoms of BPH (AUA, 2010). The level of evidence regarding the safety and utility of endoscopic balloon dilation, HIFU ablation, cryosurgical ablation, and the placement of stents, including no treatment outcome analysis for temporary prostatic stents, is insufficient to draw any conclusions. Further studies are needed before determining the role of these treatments in the routine management of men with BPH.

Endoscopic balloon dilation for treatment of BPH involves the insertion of a balloon catheter tip through the urethra into the prostatic channel where it is inflated to stretch the urethra narrowed by the prostate. Based on the research, endoscopic balloon dilation has been inadequately studied with limited controlled trials, few long-term studies, and "a fallout in enthusiasm" for this treatment (Lukkarinen, 1999). The 4th International Consultation on BPH has rated balloon dilation as an unacceptable treatment option since 1995 (Denis, 1998).

HIFU ablation is a minimally invasive procedure using a transrectal ultrasound probe to image the prostate and deliver timed bursts of heat to create coagulation necrosis in a targeted area without harming adjacent healthy tissue (Leslie, 2006). A clinical trial by Schatzl and colleagues (2000) compared the efficacy of TURP to four less invasive treatment options including HIFU. Randomization was attempted but could not be carried out because participant characteristics such as prostate size, prostatic calcifications and middle lobes limited the types of individuals who could receive the different treatments. The individuals who received HIFU tended to have smaller prostates and less severe symptoms than those who received TURP. A second study reported by Madersbacher and colleagues (2000) attempted to determine the long-term outcome after HIFU therapy for individuals with lower urinary tract symptoms (LUTS) due to BPH. The data collected between June 1992 and March 1995 indicated that HIFU therapy for BPH, at least in its present form, did not stand the test of time, as 43.8% of individuals had to undergo TURP within four years after initial therapy. Additional long-term studies are warranted to reliably assess the role of HIFU as an established alternative to standard treatments for BPH.

The use of temporary prostatic stents has been proposed for the treatment of urinary obstruction due to BPH, following surgical treatment of BPH or prostate cancer, or following radiation therapy. Intraprostatic stenting has been investigated as a short-term treatment option permitting voluntary urination as an alternative to a Foley catheter with an external collection system. A temporary prostatic stent, The Spanner™ (Abbeymoor Medical, Inc., Parkers Prairie, MN; stent since acquired by SRS Medical, North Billerica, MA), received premarket approval (PMA) from the FDA based on a multi-center, prospective, controlled, randomized clinical investigation designed to evaluate the safety and effectiveness of The Spanner to manage lower urinary symptoms and bladder emptying following TUMT treatment after an initial period of catheterization. Based on the study results, the FDA indicates "The device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization."

In The Spanner clinical investigation (Shore, 2007; Dineen, 2008), a total of 186 male subjects, 45 years of age and older, were randomized into two groups at a visit 3-10 days following TUMT for BPH, Foley catheter removal, and demonstration of a successful voiding trial (defined as a post-void residual (PVR) less than 250 ml with mean voided volume of at least 100 ml). A total of 100 subjects who received The Spanner and 86 subjects in the control group were studied for changes in International Prostate Symptom Score (IPSS), post-void residuals, and adverse events. Both groups were evaluated at one, two, and four week intervals during The Spanner indwelling period and at one and four weeks after The Spanner removal. Beginning with preoperative IPSS scores of approximately 22 points, The Spanner group score decreased by 7.28 points compared to 4.42 points in the control group, a difference of 2.86 points (p=0.019). However, although evaluation at the one week interval revealed a significant difference of three points between the groups (p=0.047), at two weeks and at subsequent visits, this was no longer the case (e.g. p=0.084 at two weeks). Mean post void residual urine (PVR) was significantly less in The Spanner group compared to controls up to four weeks following randomization, with the mean decrease from pre-insertion baseline being 6.5 mls in The Spanner group versus a 28.5 ml increase in the control group. However, after four weeks there was no significant difference in PVR between the groups.

The FDA summary reported the majority of adverse events, greater than 75% for both groups, occurred during weeks one to four following insertion. Adverse events also occurred following removal of the device and included bleeding/hematuria, urinary frequency/retention/urgency, perineal pain, and symptomatic urinary tract infection. There were 385 adverse events reported by 99 subjects in The Spanner group and 273 adverse events reported by the 80 control group subjects. Of the urological adverse events requiring treatment, bacturemia occurred in 16.0% of The Spanner group compared to 10.5% in the control group. Micturition-burning was noted in 9.0% and 5.8%; perineal pain in 5.0% and 2.3%, respectively. However, the overall incidence of perineal pain was 26% in The Spanner group compared to 12.8% in the control group. Urinary retention (undefined) occurred in 10% and 15.1%, respectively. In The Spanner group, two of these occurred after removal of the temporary stent and 3% were associated with migration. The study results are limited in demonstrating meaningful improvement in clinical outcomes in the group that received the temporary prostatic stent compared to the subjects studied who had a successful voiding trial after BPH surgery. The clinical significance of decreased IPSS scores at one week only with a difference of three points at that visit is questionable as is the difference in post-void residual noted up to four weeks, in the absence of increased urinary tract infections or other PVR related adverse effects in the control group compared to The Spanner group. On the other hand, perineal pain was noted to occur more frequently in The Spanner treated group.

Grimsley and colleagues (2007) retrospectively reviewed a series of 43 consecutive individuals who were treated with The Spanner for bladder-outlet obstruction because they were unfit for surgery (e.g. comorbidity, usually pulmonary, cardiac, or both). Six (14%) of the individuals were receiving concomitant treatment for prostate cancer. It was reported that more than half of the individuals (63%) had unsatisfactory outcomes; the remaining 37% were considered to have had satisfactory outcomes with a stent in situ after a mean of five changes or stent-free after a successful voiding trial. The authors suggest that, in this population, a temporary stent might be reasonably used only as a trial for placement of a permanent stent if voiding is unsuccessful. Additional study is needed to establish if use of The Spanner stent results in clinically significant improvement in health outcomes.

There is insufficient evidence in the peer-reviewed literature to conclude that cryosurgery ablation procedures would improve health outcomes in the treatment of BPH. In addition, additional research is needed to determine the safety and efficacy of CLAP, ILCP, PVP, VLAP, and holmium laser procedures, TULIP, RFNA/TUNA, TUMT, and WIT procedures for the treatment of individuals with genitourinary conditions other than BPH.

Background/Overview

Description of Condition

BPH is a disorder caused by the overgrowth of the prostate gland, which then interferes with the function of the bladder and urethra. BPH is sometimes referred to as benign prostatic hypertrophy. This condition usually results in the increased frequency of urination, frequent nighttime urination (nocturia), urinary hesitancy and urgency, and weak urinary stream. These symptoms appear slowly and progress gradually over years. BPH is relatively rare in younger men, affecting about 8% of men age 31 to 40 years. The incidence of BPH increases with age occurring in approximately 40-50% of men aged 51 to 60 years and over 80% of men older than age 80 years. Unless a man with BPH demonstrates symptoms that interfere with his quality of life and cannot be controlled with medical therapy, surgical intervention is rarely indicated.

Description of Technology

Treatment alternatives for individuals with moderate to severe symptoms of BPH may include watchful waiting, medical therapies, complementary and alternative medicines (CAM), minimally invasive therapies, and surgical therapies (AUA, 2010). The oldest form of surgical treatment includes open prostatectomy, either approaching the surgical site through the abdomen or through the perineum. However, this approach has been associated with significant morbidity and long hospital stays and is currently reserved for treating prostates greater than 100 grams. TURP has been the preferred treatment modality for men with BPH for many years and it remains the standard against which other treatments are compared. During this procedure, surgical equipment is inserted into the urethra and guided to the area where the prostate constricts the urethral canal. Using a cutting tool, prostate tissue is excised leaving a cleared canal and a less massive prostate. The high rate of serious complications associated with TURP, along with the high prevalence of BPH, has encouraged development of alternative surgical treatments. Newer transurethral surgical treatments are designed as an alternative to long-term medical therapy, but with the potential benefits of shorter hospital length of stay, and decreasing recovery time when compared to TURP. Other surgical approaches include laser-based procedures, TUIP, TUVP, and minimally invasive procedures including TUMT, TUNA, and WIT. In these procedures, prostate tissue is removed through a heating method that destroys the desired amount of tissue that is reabsorbed by the body or expelled during urination. Following these procedures, as with TURP, a temporary catheter (tube) is left in the urethra to keep the urinary canal open while the surgical site heals. The catheter is then removed during a follow-up visit a few days after the surgery.

Definitions

Ablation: To surgically remove or excise a body part.

Balloon dilation of the prostate: A procedure proposed to relieve urinary retention due to BPH where a flexible balloon catheter is placed in the urethra, moved up to the prostate, and then inflated for a short period of time to expand the urethra in this area.

Benign prostate hyperplasia (BPH): A condition that causes an increase in the size of the prostate gland in men, commonly causing difficulty in urination; also referred to as benign prostatic hypertrophy.

Contact laser ablation of the prostate (CLAP): A procedure where the tip of an Nd:YAG laser is placed in direct contact with prostate tissue, vaporizing it.

Cryosurgical: A treatment performed with an instrument that freezes and destroys abnormal tissue.

High-intensity focused ultrasound (HIFU) ablation of the prostate: A procedure that uses timed bursts of ultrasound to create coagulation necrosis in a targeted area of the prostate.

Holmium laser procedures of the prostate (HoLAP, HoLEP, HoLRP): Procedures that use a holmium laser fiber and specially adapted resectoscope to either ablate (HoLAP), enucleate (HoLEP), or resect (HoLRP) prostate tissue.

Hyperplasia: Enlargement of an organ or tissue because of an increase in the number of cells in that organ or tissue.

Hypertrophy: Enlargement or overgrowth of an organ or tissue due to an increase in size of its cells, rather than the number.

International Prostate Symptom Score (IPSS): An eight question, self-administered tool (seven symptom questions plus one quality of life question) used to screen for BPH-related symptoms.

Laser prostatectomy: A procedure that uses laser-generated heat to remove prostate tissue obstructing the urethra.

Lower urinary tract symptoms (LUTS): The chief complaint associated with BPH, typified by urinary frequency, urgency, nocturia, decreased and intermittent force of stream and the sensation of incomplete bladder emptying.

Stent: A tube made of metal or plastic that is inserted into a vessel or passage to keep the lumen open and prevent closure due to a stricture or external compression.

Transurethral: A surgical approach to prostate surgery that involves the insertion of surgical tools through the urethra instead of through an incision in the skin.

Transurethral vaporization of the prostate (TUVP): A surgical procedure where prostate tissue is vaporized using a grooved or spiked rollerball or thicker band-loop electrode, considered a modification of a transuretheral resection of the prostate (TURP); also referred to as transurethral electrovaporization of the prostate (TUEVP, TUVAP, TUEVAP), transurethral evaporation (TUEP), or transurethral vapor resection of the prostate (TUVRP).

Transuretheral incision of the prostate (TUIP): A surgical procedure involving one or more lengthwise incisions in the prostate near the bladder, which opens the bladder neck and prostate to reduce pressure on the urethra; usually limited to treating smaller prostate glands (equal to or less than 30 grams).

Transurethral microwave thermotherapy (TUMT): A minimally invasive treatment that uses microwave energy to heat and shrink the prostate to provide relief of urinary obstruction due to BPH.

Transurethral radiofrequency needle ablation (TUNA, RFNA): A non-surgical procedure in which low-level radiofrequency energy is delivered through a needle to a small area of the prostate, with the goal of relieving symptoms associated with BPH.

Vaporization procedures of the prostate: Procedures that use electrical energy to vaporize prostate tissues, differing from TURP and each other according to the type of electrode used and the magnitude of electrical energy applied. Prostate tissue is vaporized, resected into pieces or "chips," or coagulated. 

Visually guided laser ablation of the prostate (VLAP): A non-contact laser ablation procedure where a Nd:YAG laser is held a short distance (two millimeters) from the prostate tissue, destroying it by coagulation and allowing it to slough away over several weeks; reserved for treating small or moderately small prostates (less than 80 grams).

Water-induced thermotherapy (WIT): A minimally invasive approach to the treatment of BPH involving the use of very hot water to shrink prostate tissue; also referred to as thermourethral hot water therapy.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference.  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 are Medically Necessary:

CPT 
52450Transurethral incision of prostate [TUIP]
  
ICD-9 Diagnosis 
 All diagnoses
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
 All diagnoses

When services are also Medically Necessary:

CPT 
52647Laser coagulation of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included if performed)
52648Laser 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)
52649Laser enucleation of the prostate with morcellation, 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) [HoLRP]
53850Transurethral destruction of prostate tissue; by microwave thermotherapy [TUMT]
53852Transurethral destruction of prostate tissue; by radiofrequency thermotherapy [needle ablation, TUNA, RFNA]
53899Unlisted procedure, urinary system [when specified as transurethral destruction of prostate tissue: by water-induced thermotherapy (WIT)]
  
ICD-9 Procedure 
60.21Transurethral (ultrasound) guided laser induced prostatectomy (TULIP)
60.96Transurethral destruction of prostate tissue by microwave thermotherapy
60.97Other transurethral destruction of prostate tissue by other thermotherapy
  
ICD-9 Diagnosis 
596.0Bladder neck obstruction
600.00-600.91Hyperplasia of prostate
788.20-788.29Retention of urine
  
ICD-10 ProcedureICD-10-PCS draft codes; effective 10/01/2014:
0V507ZZDestruction of prostate, via natural or artificial opening
0V508ZZDestruction of prostate, via natural or artificial opening endoscopic
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
N13.8Other obstructive and reflux uropathy
N32.0Bladder neck obstruction
N40.0-N40.3Enlarged prostate
R33.8Other retention of urine
R33.9Retention of urine, unspecified
R39.11-R39.19Other difficulties with micturition

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above, 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 Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as not medically necessary.

CPT 
53899Unlisted procedure, urinary system [when specified as transurethral balloon dilation of the prostatic urethra]
  
ICD-9 Procedure 
60.95Transurethral balloon dilation of the prostatic urethra
  
ICD-9 Diagnosis 
 All diagnoses
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
 All diagnoses

When services are Investigational and Not Medically Necessary:

CPT 
53855Insertion of a temporary prostatic urethral stent, including urethral measurement
  
ICD-9 Diagnosis 
 All diagnoses
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
 All diagnoses

When Services are also Investigational and Not Medically Necessary:

CPT 
55873Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)
  
ICD-9 Diagnosis 
600.00-600.91Hyperplasia of prostate
  
ICD-10 DiagnosisICD-10-CM draft codes; effective 10/01/2014:
N40.0-N40.3Enlarged prostate
  
References

Peer Reviewed Publications:

  1. Ahyai SA, Lehrich K, Kuntz RM. Holmium laser enucleation versus transurethral resection of the prostate: 3-year follow-up results of a randomized clinical trial. Eur Urol. 2007; 52(5):1456-1463.
  2. Al-Ansari A, Younes N, Sampige VP, et al. GreenLight HPS 120-W laser vaporization versus transurethral resection of the prostate for treatment of benign prostatic hyperplasia: a randomized clinical trial with midterm follow-up. Eur Urol. 2010; 58(3):349-355.
  3. Albala DM, Fulmer BR, Turk TM, et al. Office-based transurethral microwave thermotherapy using the TherMatrx TMx-2000. J Endourol. 2002; 16(1):57-61.
  4. Arai Y, Aoko Y, Okubo K, et al. Impact of interventional therapy for benign prostatic hyperplasia on quality of life and sexual function: a prospective study. J Urol. 2000; 164(4):1206-1211.
  5. Araki M, Lam PN, Wong C. High-power potassium-titanyl-phosphate laser photoselective vaporization prostatectomy for symptomatic benign prostatic hyperplasia. J Endourol. 2008; 22(6):1311-1314.
  6. Bouza C, Lopez T, Magro A, et al. Systematic review and meta-analysis of transurethral needle ablation in symptomatic benign prostatic hyperplasia. BMC Urol. 2006; 6:14.
  7. Boyle P, Robertson C, Vaughan ED, et al. A meta-analysis of trials of transuretheral needle ablation for treating symptomatic benign prostatic hyperplasia. BJU Int. 2004; 94(1):83-88.
  8. Breda G, Isgro A. Treatment of benign prostatic hyperplasia with water-induced thermotherapy: experience of a single institution. J Endourol. 2002; 16(2):123-126.
  9. Brookes ST, Donovan JL, Peters TJ, et al. Sexual dysfunction in men after treatment for lower urinary tract symptoms: evidence from randomized controlled trial. BMJ. 2002; 324(7345):1059-1061.
  10. Cabelin MA, Te AE, Kaplan SA. Transurethral vaporization of the prostate: current techniques. Curr Urol Rep. 2000; (2):116-123.
  11. 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.
  12. Corica FA, Cheng L, Ramnani D, et al. Transurethral hot-water balloon thermoablation for benign prostatic hyperplasia: patient tolerance and pathologic findings. Urology. 2000; 56(1):76-80.
  13. Dahlstrand C, Waldén M, Geirsson G, Pettersson S. Transurethral microwave thermotherapy versus transurethral resection for symptomatic benign prostatic obstruction: a prospective randomized study with a 2-year follow-up. Br J Urol. 1995; 76(5):614-618.
  14. Dineen MK, Shore ND, Lumerman JH, et al. Use of a temporary prostatic stent after transurethral microwave thermotherapy reduced voiding symptoms and bother without exacerbating irritative symptoms. Urology. 2008; 71(5):873-877.
  15. Donovan JL, Peters TJ, Neal DE, et al. A randomized trial comparing transurethral resection of the prostate, laser therapy and conservative treatment of men with symptoms associated with benign prostatic enlargement: the CLasP study. J Urol. 2000; 164(1):65-70.
  16. Ekengren J, Haendler, Hahn RG. Clinical outcome 1 year after transurethral vaporization and resection of the prostate. Urology. 2000; 55(2):231-235.
  17. 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.
  18. Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): long-term results, reoperation rate, and possible impact of the learning curve. Eur Urol. 2007; 52(5):1465-1471.
  19. Floratos DL, Kiemeney LA, Rossi C, et al. Long-term followup of randomized transurethral microwave thermotherapy versus transurethral prostatic resection study. J Urol. 2001; 165(5):1533-1538.
  20. Grimsley SJ, Khan MH, Lennox E, Paterson PH. Experience with the spanner prostatic stent in patients unfit for surgery: an observational study. J Endourol. 2007; 21(9):1093-1096.
  21. Gujral S, Abrams P, Donovan JL, et al. A prospective randomized trial comparing transurethral resection of the prostate and laser therapy in men with chronic urinary retention: the ClasP study. J Urol. 2000; 164(1):59-64.
  22. Gupta NP, Doddamani D, Aron M, Hemal AK. Vapor resection: a good alternative to standard loop resection in the management of prostates >40 cc. J Endourol. 2002; 16(10):767-771.
  23. 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.
  24. Hill B, Belville W, Bruskewitz R, et al. Transurethral needle ablation versus transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia: 5-year results of a prospective, randomized, multicenter clinical trial. J Urol. 2004; 171(6 Pt 1):2336-2340.
  25. Hindley R, Mostafid A, Brierly R et al. The 2-year symptomatic and urodynamic results of a prospective randomized trial of interstitial radiofrequency therapy vs transurethral resection of the prostate. BJU Int. 2001; 88(3): 217-220.
  26. 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.
  27. Keoghane SR, Lawrence KC, Gray AM, et al. A double-blind randomized controlled trial and economic evaluation of transurethral resection vs contact laser vaporization for benign prostatic enlargement: a 3-year follow-up. BJU Int. 2000; 85(1):74-78.
  28. Keoghane SR, Sullivan ME, Doll HA, et al. Five-year data from the oxford laser prostatectomy trial. BJN Int. 2000; 86(3):227-228.
  29. Kuntz RM. Current role of lasers in the treatment of benign prostatic hyperplasia (BPH). Eur Urol. 2006; 49(6):961-969.
  30. Kuntz RM, Lehrich K, Ahyai SA. Holmium laser enucleation of the prostate versus open prostatectomy for prostates greater than 100 grams: 5-year follow-up results of a randomized clinical trial. Eur Urol. 2008; 53(1):160-166.
  31. Kupeli S, Yilmaz E, Soygur T, et al. Randomized study of transurethral resection of the prostate and combined transurethral resection and vaporization of the prostate as a therapeutic alternative in men with benign prostatic hyperplasia. J Endourology. 2001; 15(3):317-321.
  32. Leslie TA, Kennedy JE. High-intensity focused ultrasound principles, current uses, and potential for the future. Ultrasound Q. 2006; 22(4):263-272.
  33. Lourenco T, Pickard R, Vale L, et al. Alternative approaches to endoscopic ablation for benign enlargement of the prostate: systematic review of randomized controlled trials. BMJ. 2008; 337; a449.
  34. Lukkarinen O, Lehtonen T, Talja M, et al. Finastreride following balloon dilatation of the prostate. A double-blind, placebo-controlled multicenter study. Ann Chir Gynaecol. 1999; 88(4):299-303.
  35. Madersbacher S, Schatzl G, Djavan B, et al. Long-term outcome of transrectal high-intensity focused ultrasound therapy for benign prostatic hyperplasia. Eur Urol. 2000; 37(6):687-694.
  36. Michel MS, Koehrmann KU, Knoll T, et al. Clinical evaluation of a newly developed endoscopic resection device (Rotoresect): physical principle and first clinical results. Surg Endosc. 2001; 15(2):1395-1400.
  37. Miller PD, Kastner C, Ramsey EW, Parsons K. Cooled thermotherapy for the treatment of benign prostatic hyperplasia: durability of results obtained with the Targis System. Urology. 2003; 61(6):1160-1164.
  38. Muschter R, Schorsch I, Danielli L, et al. Transurethral water-induced thermotherapy for the treatment of benign prostatic hyperplasia: a prospective multicenter clinical trial. J Urol. 2000; 164(5):1565-1569.
  39. Mynderse LA, Roehrborn CG, Partin AW, et al. Results of a 5-year multicenter trial of a new generation cooled high energy transurethral microwave thermal therapy catheter for benign prostatic hyperplasia. J Urol. 2011; 185(5):1804-1810. Erratum in: J Urol. 2011; 186(1):355.
  40. Norby B, Nielsen HV, Drimodt-Moller PC. Transurethral interstitial laser coagulation of the prostate and transurethral microwave thermotherapy vs. transurethral resection or incision of the prostate: results of a randomized, controlled study in patients with symptomatic BPH. BJU Int. 2002; 90(9):853-862.
  41. Ohigashi T, Nakamura K, Nakashima J, et al. Long-term results of three different minimally invasive therapies for lower urinary tract symptoms due to benign prostatic hyperplasia: comparison at a single institute. Int J Urol. 2007; 14(4):326-330.
  42. Pace G, Selvaggio O, Palumbo F, Selvaggi FP. Initial experience with a new transurethral microwave thermotherapy treatment protocol "30-Minute TUMT." Eur Urology. 2001; 39(4):405-411.
  43. Poulakis V, Dahm P, Witzsch U, et al. Transurethral electrovaporization vs transurethral resection for symptomatic prostatic obstruction: a meta-analysis. BJU Int. 2004; 94(1):89-95.
  44. Riehmann M, Knes JM, Heisey D, et al. Transurethral resection versus incision of the prostate: a randomized, prospective study. Urology. 1995; 45(5):768-775.
  45. Roehrborn C, Burkhard F, Bruskewitz R, et al. The effects of transurethral needle ablation and resection of the prostate on pressure flow urodynamic parameters: analysis of the United States randomized study. J Urol. 1999; 162(1):92-97.
  46. 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. 
  47. Savoca G, De Stefani S, Gattuccio I, et al. Percutaneous ethanol injection of the prostate as minimally invasive treatment of benign prostatic hyperplasia: preliminary report. Eur Urol. 2001; 40(5):504-508.
  48. Schatzl G, Madersbacher S, Djavan B, et al. Two-year results of transurethral resection of the prostate versus four 'less invasive' treatment options. Eur Urol. 2000; 37(6):695-701.
  49. Shah HN, Mahajan AP, Hegde SS, Bansal MB. Peri-operative complications of holmium laser enucleation of the prostate: experience in the first 280 patients, and a review of literature. BJU Int. 2007; 100(1):94-101.
  50. Shingleton WB, Farabaugh P, May W. Three-year follow-up of laser prostatectomy versus transurethral resection of the prostate in men with benign prostatic hyperplasia. Urology. 2002; 60(2):305-308.
  51. Shore ND, Dineen MK, Saslawsky MJ, Lumerman JH. A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. J Urol. 2007; 177(3):1040-1046.
  52. Stafinski T, Menon D, Harris K, et al. Photoselective vaporization of the prostate for the treatment of benign prostatic hyperplasia. Can Urol Assoc J. 2008; 2(2):124-134.
  53. Tan A, Liao C, Mo Z, Cao Y. Meta-analysis of holmium laser enucleation versus transurethral resection of the prostate for symptomatic prostatic obstruction. Br J Surg. 2007; 94(10):1201-1208.
  54. Te AE. The next generation in laser treatments and the role of the GreenLight™ high-performance system laser. Rev Urol. 2006; 8 (Suppl 3):S24-S30.
  55. Tkocz M, Prajsner A. Comparison of long-term results of transurethral incision of the prostate with transurethral resection of the prostate, in patients with benign prostatic hypertrophy. Neurourol Urodyn. 2002; 21(2):112-116.
  56. Tugcu V, Tasci AI, Sahin S, Zorluoglu F. Comparison of photoselective vaporization of the prostate and transurethral resection of the prostate: a prospective nonrandomized bicenter trial with 2-year follow-up. J Endourol. 2008; 22(7):1519-1525.
  57. Van Melick HEH, van Venrooij GEPM, Eckhardt MD, Boon TA. A randomized controlled trial comparing transurethral resection of the prostate, contact laser prostatectomy and electrovaporization in men with benign prostatic hyperplasia: analysis of subjective changes, morbidity and mortality. J Urol. 2003; 169(4):1411-1416.
  58. Van Melick HEH, van Venrooij GEPM, Eckhardt MD, Boon TA. A randomized controlled trial comparing transurethral resection of the prostate, contact laser prostatectomy and electrovaporization in men with benign prostatic hyperplasia: urodynamic effects. J Urol. 2002; 168(3):1058-1062.
  59. Vesely S, Knutson T, Dicuio M, et al. Transurethral microwave thermotherapy: clinical results after 11 years of use. J Endourol. 2005; 19(6):730-733.
  60. Wagrell L, Schelin S, Nordling J, et al. Three-year follow-up of feedback microwave thermotherapy versus TURP for clinical BPH: a prospective randomized multicenter study. Urology. 2004; 64(4):698-702.
  61. Westenberg A, Gilling P, Kennet K, et al. Holmium laser resection of the prostate versus transurethral resection of the prostate: results of a randomized trial with 4-year minimum long-term follow-up. J Urol. 2004; 172(2):616-619.
  62. Wilson LC, Gilling PJ, Williams A, et al. A randomized trial comparing holmium laser enucleation versus transurethral resection in the treatment of prostates larger than 40 grams: results at 2 years. Eur Urol. 2006; 50(3):569-573.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Urological Association (AUA). Clinical guidelines. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm. Accessed on December 26, 2012.
    • Guideline for the Management of Clinically Localized Prostate Cancer. 2007. Reviewed and validity confirmed 2011.
    • Guideline on the Management of Benign Prostatic Hyperplasia (BPH). Revised 2010.
  2. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination for Laser Procedures. NCD #140.5. Effective May 1, 1997. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=140.5&ncd_version=1&basket=ncd%3A140%2E5%3A1%3ALaser+Procedures. Accessed on December 26, 2012.
  3. Denis L, McConnell J, Khoury S, et al. Recommendations of the International Scientific Committee: the evaluation and treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction. Proceedings of the Fourth International Consultation on Benign Prostatic Hyperplasia. United Kingdom: Health Publications, Ltd. 1998; 669-684.
  4. Hoffman RM, MacDonald R, Wilt T. Laser prostatectomy for benign prostatic obstruction. Cochrane Database Syst Rev. 2004; (1):CD001987.
  5. Hoffman RM, Monga M, Elliot SP, et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2012; (9):CD004135.
  6. NCCN Clinical Practice Guidelines in Oncology™. © 2012 National Comprehensive Cancer Network, Inc. Prostate cancer. V1.2013. December 4, 2012. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on December 26, 2012.
Web Sites for Additional Information
  1. National Cancer Institute (NCI). Prostate cancer treatment (PDQ®). September 21, 2012. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/patient. Accessed on December 26, 2012.
  2. National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC, NIH). Prostate enlargement: benign prostatic hyperplasia. Available at: http://kidney.niddk.nih.gov/kudiseases/pubs/prostateenlargement/. Accessed on December 26, 2012.
Index

Cooled Thermotherapy
GreenLight HPS® Laser System
GreenLight XPS™ Laser System
Holmium Laser (Ho:YAG)
Indigo LaserOptic Treatment® System
Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) Laser
Proleive Thermodilatation System
ProstraLund CoreTherm System
Prostatron System
Prostiva RF Therapy
Targis System
The Spanner Temporary Prostatic Stent
TherMatrx Office Thermo Therapy

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.

Document History
StatusDateAction
Reviewed02/14/2013Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale, Coding, References, Web Sites for Additional Information, and Index.
Reviewed02/16/2012MPTAC review. Updated Rationale, Discussion, Coding, References, Web Sites for Additional Information, and Index.
Reviewed05/19/2011MPTAC review. Updated Rationale, Background, Definitions, References, and Index. Added section: Web Sites for Additional Information.
Reviewed05/13/2010MPTAC review. Updated Rationale, Coding, and References.
 01/01/2010Updated Coding section with 01/01/2010 CPT changes; removed CPT 0084T deleted 12/31/2009.
Reviewed05/21/2009MPTAC review. Clarified medically necessary Position Statement, adding HoLAP and HoLEP as Holmium laser procedures; clarified VLAP statement, adding non-contact laser ablation of the prostate; added transurethral to electrovaporization and (TURVP, TUVP, TVP) acronyms. Clarified investigational and not medically necessary statement, adding (HoLAP, HoLEP) as Holmium laser prodecures and non-contact laser ablation of the prostate to the VLAP statement. Updated Rationale, Discussion, Definitions, Index, and References.
 01/01/2009Updated Coding section with 01/01/2009 CPT changes; removed CPT 53853 deleted 12/31/2008.
Revised05/14/2008MPTAC review. Revised document title to address the surgical and minimally invasive treatments that are considered investigational and not medically necessary for all genitourinary conditions other than BPH. Updated Rationale and References.
Revised02/21/2008MPTAC review. Revised document title from Surgery for Benign Prostatic Hypertrophy (BPH) to Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH). Reformatted and separated Position Statements to identify surgical and minimally invasive procedures. Updated Rationale, Background, Definitions, and References.
 01/01/2008Updated Coding section with 01/01/2008 CPT changes; removed CPT 52510 deleted 12/31/2007.  The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."  This change was approved at the November 29, 2007 MPTAC meeting.
Revised03/08/2007MPTAC review. Position Statement change, medically necessary criteria revised. Rationale and References updated.
Reviewed03/23/2006MPTAC review. Updated References.
 01/01/2006Updated Coding section with 01/01/2006 CPT/HCPCS changes
 11/18/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
Revised04/28/2005MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review DateDocument NumberTitle

Anthem, Inc.

 

01/13/2005SURG.00028Surgery for Benign Prostatic Hypertrophy (BPH)
WellPoint Health Networks, Inc.12/02/20043.08.02Treatment of Benign Prostatic Hypertrophy
 12/02/20043.08.05Temporary Prostatic Stent