Medical Policy

 

Subject: Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) and Other Genitourinary Conditions
Document #: SURG.00028 Publish Date:    08/29/2018
Status: Reviewed Last Review Date:    07/26/2018

Description/Scope

This document addresses various surgical and minimally invasive procedures used in the treatment of benign prostatic hyperplasia, and the use of these procedures for other genitourinary conditions. This document does not address the use of open prostatectomy or transurethral resection of the prostate.

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

Position Statement

Medically Necessary:

  1. The following surgical procedures are considered medically necessary as an alternative to open prostatectomy or transurethral resection of the prostate for the treatment of benign prostatic hyperplasia:
    1. Laser-based procedures that have received U.S. Food and Drug Administration approval include, but are not limited to, any of the following:
      1. Contact laser ablation of the prostate; or
      2. Holmium laser procedures, including Holmium laser ablation of the prostate, Holmium laser enucleation of the prostate, and Holmium laser resection of the prostate; or
      3. Interstitial laser coagulation of the prostate; or
      4. Photoselective laser vaporization of the prostate; or
      5. Transurethral ultrasound guided laser induced prostatectomy; or
      6. Visually guided laser ablation of the prostate, also called non-contact laser ablation of the prostate; or
    2. Transurethral incision of the prostate; or
    3. Transurethral radiofrequency needle ablation, also called transurethral needle ablation; or
    4. Transurethral vapor resection of the prostate, also called transurethral electrovaporization of the prostate, transurethral evaporation, or transurethral vaporization of the prostate.
  2. The following minimally invasive procedures are considered medically necessary as an alternative to open prostatectomy or transurethral resection of the prostate for the treatment of benign prostatic hyperplasia:
    1. Water-induced thermotherapy, also called thermourethral hot-water therapy; or
    2. Transurethral microwave thermotherapy.

Not Medically Necessary:

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

Investigational and Not Medically Necessary:

  1. The following procedures are considered investigational and not medically necessary for the treatment of benign prostatic hyperplasia:
    1. Cryosurgical ablation; or
    2. Prostatic arterial embolization; or
    3. Prostatic urethral lift; or
    4. Transurethral convective water vapor thermal ablation.
  2. Placement of temporary prostatic stents is considered investigational and not medically necessary for all indications including, but not limited to, treatment of benign prostatic hyperplasia, following surgical treatment of benign prostatic hyperplasia, prostate cancer, or radiation therapy.
  3. The following procedures are considered investigational and not medically necessary for all genitourinary conditions other than benign prostatic hyperplasia:
    1. Contact laser ablation of the prostate; or
    2. Holmium laser procedures of the prostate; or
    3. Interstitial laser coagulation of the prostate; or
    4. Photoselective laser vaporization of the prostate; or
    5. Transurethral microwave thermotherapy; or
    6. Transurethral radiofrequency needle ablation, also called transurethral needle ablation; or
    7. Transurethral ultrasound guided laser induced prostatectomy; or
    8. Visually guided laser ablation of the prostate, also called non-contact laser ablation of the prostate; or
    9. Water-induced thermotherapy, also called thermourethral hot-water therapy.
Rationale

Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH)

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 transurethral resection of the prostate (TURP) may be accompanied by undesirable complications such as blood loss, need for transfusion, and absorption of irrigation fluids. Postoperative side effects may include retrograde ejaculation and incontinence. 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.

According to the American Urological Association (AUA, 2010):

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.

Laser-based prostatectomy procedures including potassium-titanyl-phosphate photovaporization (Al-Ansari, 2010; Araki, 2008; Elmansy, 2010; Elshal, 2015; Rusvat, 2008, Stafinski, 2008, Tugcu, 2008) and other surgical and minimally invasive treatments including TUIP (Riehmann, 1995; Tkocz, 2002), transurethral microwave thermotherapy (TUMT), transurethral radiofrequency needle ablation (RFNA)/transurethral needle ablation (TUNA) (Bouza, 2006; Boyle, 2004; Hill, 2004; Hindley, 2001; Roehrborn, 1999), and transurethral vaporization of the prostate (TUVP) (Ekengren, 2000; Poulakis, 2004; Van Melick, 2002; Van Melick, 2003) have been established as useful and alternative procedures to TURP. Holmium laser procedures including Holmium laser ablation of the prostate (HoLAP) (Elmansy, 2010), Holmium laser enucleation of the prostate (HoLEP) (Ahyai, 2007; Elzayat, 2007; Kuntz, 2008; Shah, 2007; Tan, 2007; Wilson, 2006) and Holmium laser resection of the prostate (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 water-induced thermotherapy (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 an 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; Kaye, 2008; Miller, 2003; Mynderse, 2011; Norby, 2002; Ohigashi, 2007; Vesely, 2005).

Other Minimally Invasive Treatments for BPH

In June 2018, the AUA published guidelines on the Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia. These guidelines include recommendations for clinicians when considering minimally invasive treatment options, including prostatic arterial embolization, prostatic urethral lift and transurethral convective water vapor thermal ablation for the treatment of LUTS attributed to BPH. The guideline includes the following methodology when considering the evidence:

When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions. 

Prostatic Arterial Embolization (PAE)

PAE has been proposed as a treatment for BPH to reduce the blood supply of the prostate gland which results in some of the gland undergoing necrosis with subsequent shrinkage. The procedure is performed with the individual under local anesthetic using a percutaneous transfemoral approach. Embolization is achieved using microparticles (such as gelatin sponge, polyvinyl alcohol [PVA], and other synthetic biocompatible materials) introduced by super-selective catheterization to block small prostatic arteries. In June 2017, the U.S. Food and Drug Administration (FDA) granted a de novo classification to the intravascular implant, Embosphere Microspheres (BioSphere Medical, S.A., France), as a class II biocompatible PAE device for use as a minimally invasive treatment for symptomatic BPH.

Early results from a United States clinical trial evaluate the efficacy and safety of PAE in 20 men with BPH (Bagla, 2014). Following embolization, 19 of 20 participants experienced average AUA symptom score improvements of 10.8 points (p<0.0001), 12.1 points (p=0.0003) and 9.8 points (p=0.007) at 1, 3, and 6 months, respectively. Improvements were also reported in quality of life-related symptoms and sexual function. Prostate volume decreased 18% (p=0.05) in 5 individuals at 6 months. Limitations of this trial include lack of a comparator treatment group, blinding, and randomization, the small sample size, and short-term follow-up of outcome measures.

Pisco and colleagues (2013) conducted two prospective, nonrandomized studies in Portugal evaluating short-, intermediate-, and mid-term outcomes of PAE in men with BPH. The largest study with mid-term results evaluated 255 participants for a mean follow-up period of 10 months (range 1-36 months). All participants were on medical therapy for BPH with persistent moderate to severe symptoms for more than 6 months. Eight participants had TURP years before and 32 participants had bladder catheters at the time due to acute urinary retention. PAE was reported as “technically successful” in 238 of 250 participants, defined as PAE completed in at least one pelvic side. Clinical success was reported as the mean value over time of response to effectiveness variables including International Prostate Symptom Score (IPSS), quality of life score, International Index Erectile Function (IIEF), uroflowmetry, and prostate specific antigen (PSA) levels and volume. Most clinical changes and success occurred in the first month after PAE in 195 (81.9%) participants with clinical failures in 43 (18.1%) participants. Cumulative rates of clinical success, defined as improving symptoms and quality of life, at 6 and 12 months were 78% and 75%, respectively. A statistically significant improvement over time of all evaluated parameters was observed; however, there was not a relationship between the reduction in prostatic volume and the clinical outcome (p=0.12). An improvement in the mean uroflowmetry obtained after PAE was modest compared to individuals who are treated surgically by TURP, reported as 51% for PAE compared to 125% for TURP. Additional study with long-term follow-up is needed to address the question of longevity of this PAE outcome. There was only one major complication reported (bladder ischemia) and no cases of sexual dysfunction including impotence or retrograde ejaculation. Limitations of this single-center study include lack of randomization, absence of a comparator treatment group, and short-term follow-up of outcome measurements; a potential bias also exists concerning the use of questionnaires to validate subjective outcome measures.

PAE for symptomatic BPH has been assessed in small case series and single-center studies evaluating measures of clinical symptom improvement (Carneval, 2013; Rio Tinto, 2012), laboratory and urodynamic findings (Antunes, 2013), use of different PVA particle sizes (Bilhim, 2013a), clinical outcomes comparing unilateral to bilateral PAE (Bilhim, 2013b), and quality of life measures. Few post-PAE complications were reported in these studies, including urinary tract infection requiring antibiotics and acute post-PAE urinary retention requiring temporary catheterization. Despite some promising preliminary results, including the potential for reduced morbidity and avoidance of general anesthesia, additional multicenter randomized controlled trials with long-term follow-up are needed to evaluate the safety and durability of the clinical benefits of PAE over standard surgical procedures for the treatment of moderate to severe lower urinary tract symptoms (LUTS) secondary to BPH.

Grosso and colleagues (2015) reported clinical outcomes after PAE in a small cohort of 13 consecutive individuals (mean age 75.9 years) with treatment refractory BPH and LUTS. Seven participants had failed drug therapy and were dependent on an indwelling bladder catheter. The clinical follow-up (mean follow-up time of 244 days) was performed using the IPSS, the IIEF, blood PSA testing, transrectal prostatic ultrasound scan with volume and weight calculation, and quality of life measures at 3, 6, and 12 months. Embolization was performed using 300 to 500 micron Embosphere Microspheres® (Merit Medical Systems, Inc., South Jordan, UT). Technical success was defined when selective PAE was completed in at least one pelvic side. Clinical success was defined as improvement in symptoms and quality of life measures. PAE was reported as technically successful in 12 of 13 participants (92 %). PAE was not performed in 1 participant because of tortuosity and atherosclerosis of iliac arteries. Bilateral PAE was completed in 9 of 13 (75 %) participants and unilaterally in 3 (27 %). All participants had their indwelling bladder catheter removed from 4 days to 4 weeks postoperative PAE. Participants experienced a reduction in IPSS (mean of 17.1 points), an increase in IIEF (mean of 2.6 points), an improvement in quality of life measures (mean of 2.6 points), and a volume reduction (mean of 28 %) at 12 months. The authors concluded that PAE may be an option for the management of individuals in whom medical therapy has failed for BPH and LUTS. Limitations of this study include the small sample size and lack of a comparator group. Additional study is needed to evaluate the long-term safety and efficacy of PAE in medically refractory individuals who are not candidates for surgery or TURP or refuse any surgical treatment for indwelling bladder catheter-dependent BPH and LUTS.

Wang and colleagues (2016) evaluated the use of PAE for large (> 80 mL) and medium-sized (50-80 mL) prostate glands to determine whether preoperative gland size affects treatment outcomes. A total of 115 individuals (mean age 71.5 years) diagnosed with LUTS attributed to treatment-refractory BPH underwent PAE. Group A (n=64) included individuals with a mean prostate volume of 129 mL; group B (n=51) included those with a mean prostate volume of 64 mL. PAE was performed using 100-μm embolization particles. There were no significant differences between groups in baseline measurements of IPSS, peak urinary flow rate (Qmax), post-void residual urine volume (PVR), and IIEF-5 scores. In addition to these measures, quality of life, PSA, and prostate volume measured by magnetic resonance imaging (MRI) was performed at 1, 3 and 6 months, and every 6 months thereafter. The technical success rate of PAE was 93.8% in group A and 96.8% in group B (p=0.7). A total of 101 participants (n=55, group A; n=46, group B) completed the mean (range) follow-up of 17 (12-33) months. Compared with baseline, there were significant improvements in IPSS, quality of life, Qmax, prostate volume, and PVR in both groups after PAE. The outcomes in group A were significantly better than in group B for the mean IPSS (standard deviation [SD], -14 ± 6.5 vs. -10.5 ± 5.5, respectively), Qmax (6.0 ± 1.5 vs. 4.5 ± 1.0 mL/s, respectively), PVR (-80.0 ± 25.0 vs. -60.0 ± 20.0 mL, respectively), prostate volume (-54.5 ± 18.0 mL [-42.3%] vs. -18.5 ± 5.0 mL [-28.9%], respectively), and quality of life scores (-3.0 ± 1.5 vs. -2.0 ± 1.0) (p<0.05, all measures). The mean IIEF-5 score was not significantly different from baseline in both groups. The investigators reported no major complications with PAE and clinical and imaging outcomes were better in individuals with larger prostate glands than medium-sized ones. Limitations of this study include evaluation of individuals from a single institution, short-term follow-up of outcome measures, and lack of matched-pair comparisons to other procedures for the treatment of LUTS attributed to BPH.

Pisco and colleagues (2016) reported on the medium- and long-term effect of PAE in symptomatic BPH. A total of 630 individuals with BPH and moderate to severe LUTS refractory to medical therapy for at least 6 months or who refused any medical therapy underwent PAE. Outcomes were evaluated at baseline, 1, 3, and 6 months; every 6 months between 1 and 3 years; and, yearly thereafter up to 6.5 years. The mean participant age was 65.1 years ± 8.0 (range, 40-89 years). There were 12 (1.9%) technical failures with the procedure. Bilateral PAE was performed in 572 (92.6%) participants and unilateral PAE was performed in 46 (7.4%) participants. A total of 10 of 58 participants who underwent repeat PAE were lost to follow-up before any data could be obtained. There was a statistically significant change from baseline to last observed value reported in all clinical parameters including IPSS, quality of life, PVR, PSA, Qmax, and IIER, defined as clinical success rates of 81.9% and 76.3% at medium- (1-3 year) and long-term (> 3-6.5 years) follow-up, respectively (p<0.0001). There was one PAE-related major adverse event, a case of bladder wall ischemia treated by simple surgery, and another participant experienced uncomfortable perineal pain lasting for 3 months. Limitations of this study include the nonrandomized study design and lack of a control group of participants treated with other BPH therapies for comparison.

Shim and colleagues (2017) conducted a systematic review and meta-analysis/meta-regression analysis to determine the overall treatment efficacy and safety of PAE compared with standard therapy for the treatment of BPH. Meta-analyses were performed of randomized, controlled and single group trials. Meta-regression analysis of the moderator effect was performed with single group analysis. A total of 16 studies, 3 comparative studies (n=297 subjects; n=149 in the experimental groups and N=148 in the control groups) and 13 noncomparative studies (n=750 subjects), were included in the meta-analysis. The outcomes measures were mean changes in IPSS, quality of life, Qmax, prostate volume, PVR and PSA. Adverse events were compared as proportional differences between the embolization group and groups receiving other therapies in comparative studies. Pooled overall standardized mean difference (SMD) in the mean change from baseline for the PAE compared with the control group were 0.88 (95% CI, 0.10-1.66) for IPSS, -1.44 (95% CI, -2.30 to -0.58) for Qmax, and 0.48 (95% CI, 0.14-0.82) for prostate volume. Pooled overall SMDs of the PAE group in IPSS, Qmax and prostate volume were significantly reduced compared with the control group. Pooled overall SMDs in the mean change from baseline for the PAE compared with the control group were 0.25 (95% CI, -0.28-0.77) for quality of life, 0.14 (95% CI, -0.18-0.46) for PVR, 0.05 (95% CI, -1.52-1.62) for IIEF and 0.46 (95% CI, -0.02-0.95) for PSA. There were no statistical differences in these measures between the 2 groups. Sensitivity analysis of study duration showed that all outcome measurements did not differ before PAE and 6 months after PAE. There are several limitations to meta-analysis, including the small number of comparative studies and lack of trials comparing PAE to other treatment modalities, including laser resection procedures. The authors concluded that PAE for the treatment of BPH “…should still be considered an experimental treatment modality.”

Other Considerations

The 2018 AUA guideline on Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (2018) does not recommend PAE “…for the treatment of LUTS attributed to BPH outside the context of a clinical trial (Expert Opinion).”

A Society of Interventional Radiology (SIR) (McWilliams, 2014) position statement for use of prostate artery embolization for the treatment of benign disease of the prostate states:

Although there maybe emergency indications for PAE for post-operative bleeding or other urgent indications, elective PAE for BPH requires additional investigation before its acceptance into routine therapy. Additional studies, some of which are ongoing, should investigate midterm and long-term efficacy of the procedure, including subjective symptom scores and objective measures such as peak flow rate, prostate volume, and post void residual volume. Prospective, randomized comparison versus TURP and other surgical therapies will help delineate the role of PAE among the many treatment options for LUTS. Safety of the procedure should continue to be verified by tracking and reporting of adverse events.

In summary, most studies evaluating PAE for the treatment of LUTS secondary to BPH lack a control group, have a degree of variation in the reported rates of symptom improvement, and lack comparisons to standard therapies such as TURP or open prostatectomy. Additional well-designed randomized controlled trials are needed to determine the net health benefit of PAE compared to other procedures in the treatment of LUTS secondary to BPH.

Prostatic Urethral Lift (PUL) System

The PUL system is a minimally invasive treatment for symptomatic LUTS secondary to BPH. The NeoTract UroLift® System (NeoTract Inc., Pleasanton, CA) received FDA 510(k) designation (K130651) on September 13, 2013 as a de novo device indicated for the treatment of men 50 years of age and older with LUTS secondary to BPH. The procedure is performed by transurethral delivery of small PUL implants to secure the prostatic lobes in an open position, thereby reducing the obstruction of the urethral lumen.

Chin and colleagues (2012) evaluated the 2-year results of the UroLift in an industry-sponsored, prospective, nonrandomized multicenter Australia-based trial of 64 men, ages 55 years or older, with moderate to severe symptomatic BPH. The implant technique was refined during the course of the study using cystoscopic and symptomatic results from participants treated early in the study. To evaluate effectiveness, a general estimating equation model was adapted to each output parameter, including IPSS, quality of life, BPH Impact Index (BP-HII), and peak urethral flow rate assessed at 2 weeks, and 3, 6, 12, and 24 months. In the evaluable participants, IPSS was reduced from the baseline by 42%, 49%, and 42% at 2 weeks, 6 months, and 2 years, respectively. No compromise in sexual function was observed after treatment and the average Sexual Health Inventory for Men (SHIM) questionnaire score at each follow-up interval was slightly increased compared with baseline, although these differences were not statistically significant. The early postoperative course was typical of an endoscopic procedure in terms of irritative symptoms, including dysuria and mild hematuria, which resolved in the first week. Other post-procedure adverse events included epididymo-orchitis (n=1), rigor (n=1), prostatitis (n=1), and urinary tract infection (n=7). A total of 34 of 64 participants (53%) required postoperative catheterization; however, 75% of the catheters were removed the day after the implant procedure. Two participants underwent TURP within 30 days due to lack of response to the PUL. No compromise in erectile or ejaculatory function was observed. At the end of 2-year follow-up, 20% (13 of 64) of participants underwent TURP, photoselective laser vaporization of the prostate (PVP), or repeat PUL procedures due to return of LUTS. Limitations of this study include lack of an active or sham control group, limited sample size for some outcome measures, lack of inclusion criteria related to sexual function or sexual activity, limited durability of results for some participants as the device was changed and implant procedural technique refined during the course of the study, and lack of sustained response and return of LUTS in 20% of participants after PUL implant (which required repeat treatment).

L.I.F.T Study

Roehrborn and colleagues (2013) reported results of the multicenter prospective trial (L.I.F.T.) of the UroLift System for the treatment of LUTS secondary to BPH. The 2-phase study included a randomized single-blinded period, starting at the time of the procedure and ending at the participant’s 3-month visit, followed by a nonrandomized open-label period. After the 3-month follow-up visit, if symptoms returned and treatment was required, participants were allowed to receive treatment with the UroLift System or any other approved BPH treatment. A total of 206 men, ages 50 years or older, with AUA Symptom Index (AUASI) 13 or greater, maximum flow rate 12 milliliters per second or less, and a prostate size of 30 to 89 cubic centimeters were randomized 2:1 between PUL device (n=140) or sham treatment (n=66). The primary efficacy endpoint (intention-to-treat [ITT]) was demonstration of a reduction in AUASI at least 25% greater than that of sham treatment at 3 months post-PUL procedure; all participants in the PUL group were followed through 1 year to evaluate durability of effect. Secondary effectiveness endpoints included measurements in Qmax at 3 and 12 months, IPSS at 2 weeks, and quality of life and BPH-II at 12 months. The primary safety endpoint was to demonstrate an observed rate of ≤ 10% postoperative urinary catheterization for more than 7 days. After the 3-month endpoint, all participants were unblinded to treatment; 53 of 66 participants in the sham treatment group elected to undergo the PUL procedure. Follow-up outcomes for those individuals were not reported in this study. At 12 months, 123 participants were included in the analysis: 1 participant dropped out, 2 were excluded due to significant protocol deviations, 5 participants elected to undergo PUL revision because of insufficient response, 2 participants elected prostate resection, and 7 participants were removed due to BPH medication use. The primary study endpoint was met, as the mean PUL and sham AUASI was reduced by 11.1 (± 7.67) and 5.9 (± 7.66), respectively (p=0.003). PUL participants experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months, respectively (p<0.001). Qmax improvement increased 4.4 milliliters per second at 3 months and was sustained at 4.0 milliliters per second at 12 months (p<0.001). There was no statistical difference between groups in IIEF. Two serious adverse events were determined as related to the procedure (clot retention coincident with reinitiating warfarin therapy and removal of a bladder stone at 12 months). Less serious adverse events, including postoperative dysuria, hematuria, pain/discomfort and urgency were typically mild to moderate and resolved within 2 weeks. Limitations of this study include the lack of blinding and absence of a comparator treatment group beyond the primary study endpoint follow-up visit. The rate of blinding for participants was reported at 57% at the 3-month follow-up. Of the 140 participants in the treatment arm, 20% (17 participants) were excluded in the final analysis (unblinded phase) at 12 months.

Cantwell and colleagues (2014) reported outcomes from an industry-sponsored crossover study recruiting participants who received sham treatment during the L.I.F.T. trial (Roehrborn, 2013). A total of 53 participants who crossed over and were unblinded to treatment at 3 months elected to undergo PUL. At 12 months after PUL and with each participant serving as his own control, the clinical effects of PUL associated with early symptom relief, low morbidity and preservation of sexual function corroborated findings in the randomized L.I.F.T. trial; however, as the study was unblinded, the possibility of a placebo effect cannot be excluded. In addition, the durability of PUL was not evaluated beyond 1 year.

Additional case series have evaluated data obtained from the 2-year nonrandomized trial (Chin, 2012) and the L.I.F.T. trial (Roehrborn, 2013) for treatment of LUTS secondary to BPH. These retrospective reviews evaluate preservation of sexual function (McVary, 2014; Woo, 2012) and improvement in voiding flow, symptom relief, and the surgical technique involved with minimally invasive PUL in men with a history of symptomatic BPH (McNicholas, 2013). In the McNicholas study (2013), 102 participants were successfully implanted with a mean of 4.5 implants with no reported serious adverse events. The mean IPSS, quality of life, and peak flow rate score improved 36%, 39%, and 38% by 2 weeks, and 52%, 53%, and 51% at 2 months (p<0.001), respectively. The analysis did not collect sexual function data using a validated data collection tool. A total of 4 (6.5%) participants experienced insufficient improvement and TURP was performed without complications. Limitations of this study include analysis of participant records from a nonblinded single-arm registry, lack of comparator treatments, and short-term follow-up intervals. Shore and colleagues (2014) performed an open-label study of 51 participants treated with PUL for BPH, attempting to further characterize the “perioperative subject experience” with the procedure, in terms of tolerability of local anesthesia, perioperative recovery and work productivity (return to work/days absent from work). The procedure was tolerated under local anesthesia and 86% of participants reported achieving a high quality of recovery by 1 month. The results of these studies corroborate the prior published results; however, larger prospective randomized studies with comparator treatment groups and long-term follow-up are needed to confirm the durability of the clinical benefits of PUL over standard surgical procedures for the treatment of LUTS secondary to BPH.

The long-term safety, efficacy, and durability of PUL for moderate to severe BPH are reported in the 3-year results of the L.I.F.T study (Roehrborn, 2015). After randomized comparison at 3 months, 129 of 140 (92.1%) participants were followed for 3 years (n=11, lost to follow-up) and assessed for LUTS severity (IPSS), quality of life, peak flow rate, sexual function, and adverse events. To evaluate per protocol change from baseline, the authors used a general estimating equation (GEE) model for each output parameter to calculate p values for each follow-up interval compared to baseline. Change from baseline was the dependent variable; visit and baseline score were used as independent variables. A total of 93 of the original cohort of 140 (66.4%) participants (that is, participants allocated to PUL and included in the ITT analysis performed at 3 months) were included in the final 3-year effectiveness analysis. Of the 36 participants excluded, 13 participants had used alpha-blocker or 5-alpha reductase inhibitors, 3 participants had missing data, 3 participants deviated from the study protocol, and 2 participants had an unrelated prostate procedure. For the remaining 15 participants (of the original 140 participants randomized to PUL [10.7%]), 6 men received additional PUL implants and 9 men required surgical intervention with TURP or laser vaporization for treatment failure; however, the authors state “this rate is similar to rates reported after TURP (2.3-4.3% at 1 year, 5.8%-9.7% at 5 years) and laser vaporization (1.7%-5.3% at 1 year, 6.7% at 2 years, 6.8%-34% at 5 years).” The therapeutic effects of PUL, reported as average improvements from baseline through 3 years, were significant for total IPSS (41.1%), quality of life (48.8%), peak flow rate score (53.1%), and individual IPSS symptoms (p<0.0001 [GEE], respectively). For PUL participants, sexual function was preserved with no reported adverse events or de novo sustained erectile or ejaculatory dysfunction. Concerning the latter, the authors state “most medications and all of the invasive options for the management of benign prostatic obstruction (BPO) have been shown to have a negative impact on ejaculatory function.” In addition, “prostate volume, prostate length, number of placed implants, and the density of placed implants are not correlated with symptom relief and do not appear to predict response to the procedure.” Despite the lack of direct comparison data, the authors state the results of this study “suggest that the overall secondary procedure rate after PUL would be considerably less than after TUMT (31%-40% at 3 years) and TUNA (20%-36% at 2-3 years).” Limitations of this study include the methodological use of a GEE (estimation) model for each parameter to correlate data from baseline to 3 years for repeated study measures. This methodology may result in underestimation of errors unless the sample size is very large. In addition, ITT analysis of data was performed at 3 months but not at the 3-year follow-up, as only 93 of the 140 (66.4%) PUL-treated participants were included in the final “per protocol” analysis. Additional randomized studies with ITT analysis of longitudinal data are needed to compare the clinical efficacy and durability of PUL to other minimally invasive and surgical interventions for the treatment of LUTS from BPH.

Roehrborn (2016) described the surgical technique (including preoperative planning, surgical approach and procedure, postoperative care, and rehabilitation and recovery) involved with use of the PUL procedure to treat LUTS secondary to BPH. This review article also reports the 4-year data from the crossover study originally published in 2013 (L.I.F.T. trial). In that study, 206 participants were randomized 2:1 between the PUL procedure and a sham procedure. The study was unblinded at 3 months, and 53 of 66 participants who underwent the sham procedure elected to undergo PUL. The data reported includes a summary table of composite (mean) IPSS improvements from four published but unspecified studies. Sustained improvements in a variety of outcomes over a 4-year period are reported, but the summary table showing this data does not clearly attribute the reported numbers to any specific studies. The initial trial treated 193 participants, but a matched-paired analysis reported 4-year outcomes for only 55 to 79 participants (depending on the outcome measure), and to whom the study subjects were matched is unclear. Of the 140 originally randomized participants, 32 participants were lost by the 4-year follow-up visit (6 losses were deaths). Of the remaining 108 participants for whom data were available, an additional 29 participants were excluded from analysis for BPH retreatment or protocol deviations. For the 79 (56%) of the 140 participants included in the analysis, change in IPSS score was -8.8 (precision not given) or -41% (95% CI, -49% to -33%; p<0.001). Significant improvements compared to baseline were also reported for quality of life, Benign Prostatic Hyperplasia Impact Index (BPH-II), and Qmax. A total of 140 participants (14%) had surgical retreatment by 4 years. SHIM scores did not differ statistically from baseline. Adverse events in the large studies were reported as mild to moderate hematuria (26%- 80%), dysuria (38%-74%), irritative symptoms/discomfort (21%-52%), urinary tract infection (7%-11%), urinary retention (9%), and urge incontinence (2%-9%), with most events resolving within 2 to 4 weeks.    

Roehrborn and colleagues (2017a) reported 5-year results from the crossover study (L.I.F.T. trial) published in 2013 in which the PUL procedure was used to treat LUTS secondary to BPH. After randomized comparison at 3 months when additional implants were allowed, participants were followed to 5 years. PUL participants were assessed on symptom control (IPSS), quality of life, BPH-II, Qmax, sexual function, and adverse events. Participants who underwent an additional BPH procedure, were taking a BPH medication, or deviated from study protocol were excluded from the per protocol (PP) analysis; for participants in the ITT analysis, the last value prior to study exclusion was carried forward. The ITT and PP analysis results were reported as “durable” through 5 years in IPSS (ITT, 35%; PP, 36%), quality of life (ITT, 44%; PP, 50%), BPH-II (ITT, 47%; PP, 52%), and Qmax (ITT, 50%; PP, 44%). For 72 (51.4%) of 140 participants included in the PP analysis, change in IPSS score from baseline to 5 years was -7.56 or -35.9% (95% CI, -44.4% to -27.3%; p<0.0001). For the 140 participants included in the ITT analysis, change in IPSS score from baseline to 5 years was -7.85 or -35.0% (95% CI, -41.0 to -29.0%; p<0.0001). There was no significant difference in any efficacy measures between the PP and ITT analysis. Of the 140 originally randomized participants, data were available for 104 (74.3%) participants at 5 years of follow-up. Of the 36 not available, 18 (12.9%) participants were lost to follow-up, 9 (6.4%) died of unrelated causes, and 9 (6.4%) participants exited the study for either treatment of unrelated cancer (n=5) or after undergoing TURP (n=4). A total of 19 (13.6%) participants were surgically retreated for “failure to cure” following PUL at 5 years: 6 (4.3%) received additional PUL implants and 13 (9.3%) participants were treated with TURP or laser ablation (including 4 participants that exited the study). There was one adverse event occurring in one participant over the time period of 49 to 60 months (hematuria). Sexual function was stable over 5 years with no de novo, sustained erectile or ejaculatory dysfunction.

BPH6 Study

Sonksen and colleagues (2015) reported on the 12-month results of the BPH6 study, a prospective, randomized study conducted across three European countries (10 centers) comparing PUL (n=45) to TURP (n=35) in 80 participants 50 years of age and older who were candidates for TURP. After initial randomization (n=91), 10 individuals (10.9%) allocated to TURP and 1 individual (1%) allocated to PUL withdrew from the study, declining the index treatment. The primary study endpoint assessed a composite of six elements (that is, symptom relief, quality of recovery, erectile function preservation, ejaculatory function preservation, continence preservation, and safety) with the overall objective “to show that the success rate for PUL is not inferior to TURP in terms of the composite endpoint at 12 mo.” Noninferiority was evaluated using a 1-sided lower 95% CI for the difference between PUL and TURP performance. Participants were matched between the study arms, with no statistically significant differences in baseline parameters except for Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EJD) score; only 1 participant was excluded from the final analysis for a study protocol violation. In addition to PUL participants consistently demonstrating a more rapid recovery than TURP participants, significant improvements were observed in both study groups over time in IPSS, IPSS quality of life, BPH impact index, and Qmax; however, IPSS, Qmax, and PVR were better after TURP than after PUL (p<0.05). Erectile function was preserved in both PUL and TURP groups with only 1 participant in the PUL group (2.6%) and 2 participants in the TURP group (6.1%) experiencing a consistent drop in SHIM score after the procedure. The proportion of participants who met the original BPH6 primary endpoint was 34.9% for the PUL group and 8.6% for the TURP group (noninferiority, p=0.0002; superiority, p=0.006). After adjusting for any difference in baseline parameters between the enrollment arms, the refined BPH6 primary endpoint was also met by 52.3% of PUL participants and 20.0% of TURP participants (noninferiority, p<0.0001; superiority, p=0.005). Reintervention for treatment failure occurred in 6.8% (3 of 44) of PUL participants and 5.7% (2 of 35) TURP participants. Two participants in the TURP group required surgical intervention for adverse events; in addition, PUL participants experienced fewer treatment-related infections (7%) than TURP participants (14%) (p=0.46). In the final analysis, the PUL procedure met the primary study endpoint of noninferiority and demonstrated superiority in the BPH6 primary endpoint; however, TURP was superior in reducing IPSS reduction goal of ≥ 30% (73% vs. 91%; p=0.05) where PUL was superior for quality of recovery (p=0.008) and preservation of ejaculatory function (p<0.0001). Limitations of this study include the short-term follow-up of 1 year and the study sample size, which was insufficiently powered to detect meaningful differences in secondary endpoints.

Gratzke and colleagues (2017) reported on 2-year participant-centered and quality of life assessment outcomes of the prospective, randomized, controlled, non-blinded BPH6 trial (n=45 PUL participants; n=35 TURP participants) following PUL for symptomatic BPH. At 24-month follow-up, the mean difference (change) in IPSS between PUL and TURP favored TURP (6.1; standard deviation, -9.2 to -15.3, respectively; p<0.001). Subjective outcomes of participant-reported quality of life were similar between PUL (n=45) and TURP (n=35) participants at all follow-up intervals. TURP was superior with regard to Qmax scores at all study time points, while changes in health-related quality of life and BPH-II improvements were not statistically different; changes in prostate volume were not reported. Ejaculatory function bother scores did not change significantly in either treatment arm while PUL resulted in statistically significant improvement in sleep. Reoperation rates due to symptom recurrence among PUL and TURP participants did not differ significantly over the 2-year study. Six participants in the PUL arm (13.6%) and 2 participants in the TURP arm (5.7%) underwent secondary treatment for return of LUTS. The participant-reported incidence for incontinence (incontinence severity index [ISI]) change from baseline over time was statistically significant at 2 weeks and 3 months following TURP compared with PUL; however, the change over time was statistically insignificant after 6 months through 24 months of follow-up. Limitations of this study include the small sample size, “…which may not have provided sufficient statistical power to detect differences in some of the secondary outcome variables.” Another study limitation includes use of the BPH6 composite endpoint, as it is not a validated study instrument, despite being composed of individually validated instruments. Additionally, subjective, patient-reported questionnaires assessing 2-year study outcomes, including the Patient Global Impression of Improvement (PGI-I), Short-Form Health Survey (SF-12), and other surveys, are not historically used in reporting quality of life outcomes in urological studies or in the other studies of PUL for the treatment of symptomatic BPH. The authors state ‘this finding supports the need for a future BPH6 validation study assessing all BPO-related LUTS therapies.”

Other Considerations for PUL for BPH

Perera and colleagues (2014) performed a systematic review and meta-analysis of the retrospective and prospective studies evaluating symptomatic, functional, and sexual outcomes following the PUL procedure. A total of 10 publications (including the studies previously addressed in the Rationale of this document) were included in the analysis pooling estimates from 452 and 680 treated individuals. At 12 months follow-up, an improvement of LUTS symptoms was observed when estimated on the IPSS scale (improvement of -0.8 points, 95% confidence interval [CI], -8.8 to 7.2). Assessment of functional outcomes (that is, Qmax, PVR) was limited due to inconsistent reporting at selected intervals in some of the studies. Pooled estimates were observed for Qmax with an improvement of between 3.80 ml/s (95% CI, 3.0-4.6) and 4.0 ml/s (95% CI, 3.4-4.6) during 1 month and 12 months in three studies; however, the authors suggested “the values obtained are not suitable for direct comparisons with alternative therapies, and the resulting improvements in Qmax should be considered with caution.”  Despite the functional improvements in Qmax which appear noninferior in this meta-analysis, when compared with current medical and minimally invasive therapies, these “...improvements following PUL are fewer than those following surgical interventions including TURP and PVP, which are associated with an improved Qmax of between 10 and 13 ml/s at 12 months follow-up.” Sexual function was reported as preserved with a consistently small improvement estimated throughout follow-up (standardized mean gain range, 0.3-0.4). Limitations of this analysis include a high degree of heterogeneity and varying quality in the reviewed studies. The long-term durability of the device could not be commented on by the authors with only a 12-month follow-up. Publication bias and favorable reporting could not be discounted “owing to commercial interests with the current method of PUL.” The authors concluded that longer follow-up and larger randomized comparative studies are needed as the “current evidence suggests that the currently described PUL procedure requires alteration to improve functional performance for equivalence with surgical interventions.”  Jones and colleagues (2016) performed a systematic review of UroLift studies with at least 12 months of follow-up. A total of seven studies were identified, which included four noncomparative studies (Bozkurt, 2016; Chin, 2012; McNicholas, 2013; Woo, 2012), one crossover study (Cantwell, 2014), and two randomized controlled trials (Roehrborn, 2013; Sonksen, 2015). The review included data from 440 subjects; however, only data were included from men in the UroLift arms of the randomized controlled trials. Summaries were created from the combined study results, but the methods used to combine the data for meta-analysis were not described and precision estimates were not given. The authors reported that mean Qmax increased from 8.4 mL/s to 11.8 mL/s, mean IPSS improved from 24.1 to 14, mean quality of life improved from 4.5 to 2.3, and mean 5-item IIEF score improved from 17.7 to 18.2. The most frequent complications reported were dysuria, hematuria and pelvic pain.

The 2018 AUA guideline on the Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia includes the following recommendations for use of PUL for LUTS attributed to BPH:

Clinicians should consider PUL as an option for patients with LUTS attributed to BPH provided prostate volume <80g and verified absence of an obstructive middle lobe; however, patients should be informed that symptom reduction and flow rate improvement is less significant compared to TURP (Moderate Recommendation; Evidence Level: Grade C).

PUL may be offered to eligible patients concerned with erectile and ejaculatory function for the treatment of LUTS attributed to BPH (Conditional Recommendation; Evidence Level: Grade C).

Summary for Use of PUL for BPH

The evidence for the clinical use of PUL for individuals with lower urinary tract obstruction symptoms due to BPH includes noncomparative studies, randomized controlled trials, and systematic reviews. Relevant outcomes include functional outcomes, health status measures, quality of life, symptoms, and treatment-related morbidity. The L.I.F.T. study (Roehrborn, 2013) was a randomized controlled trial comparing PUL with sham control that reported the PUL procedure is associated with greater improvements in LUTS than medical management, without worsened sexual function. Two publications from this trial reported that functional improvements were durable over 3-, 4-, and 5-year follow-ups in a subset of subjects, but this conclusion is limited because only treated subjects were included in the longer follow-up and there was a high loss to follow-up in the treated group. Another randomized controlled trial, the BPH6 study (Sønksen, 2015) compared the PUL procedure with TURP and reported that PUL was noninferior for the study’s composite endpoint, which included multiple measures of symptoms and complications combined into a single score. While TURP was associated with greater improvements in urinary tract obstruction symptom outcomes, it was also associated with greater declines in sexual function than PUL. This small trial was limited by unequal dropout rates between groups after enrollment, and uncertainty about the validity of its primary composite outcome measure. The composite measure was composed mostly of safety items, which may have biased outcomes in favor of the PUL group. Because of limitations with the BPH6 trial, its results do not definitively demonstrate the noninferiority of PUL to TURP; more evidence is needed to corroborate these results. In addition, follow-up in the available studies was inadequate to identify longer term adverse events. The evidence is insufficient to determine the long-term efficacy of PUL to improve health outcomes in symptomatic individuals with lower urinary tract obstruction due to BPH.

Temporary Prostatic Stents

The use of temporary prostatic stents has been proposed as 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 an indwelling bladder catheter with an external collection system. A temporary prostatic stent, The Spanner™ (SRS Medical, North Billerica, MA), received premarket approval (PMA) from the FDA based on a multicenter, prospective, randomized clinical trial designed to evaluate the safety and effectiveness of The Spanner to manage LUTS 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 (Dineen, 2008; Shore, 2007), a total of 186 male subjects, 45 years of age and older, were randomized into 2 groups at a visit 3 to 10 days following TUMT for BPH, indwelling bladder catheter removal, and demonstration of a successful voiding trial (defined as a PVR less than 250 milliliters with mean voided volume of at least 100 milliliters). A total of 100 subjects who received The Spanner and 86 subjects in the control group were studied for changes in IPSS, PVR, and adverse events. Both groups were evaluated at 1-, 2-, and 4-week intervals during The Spanner indwelling period and at 2 and 4 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 1-week interval revealed a significant difference of 3 points between the groups (p=0.047), at 2 weeks and at subsequent visits, this was no longer the case (p=0.084 at 2 weeks). Mean PVR was significantly less in The Spanner group compared to controls up to 4 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 4 weeks there was no significant difference in PVR between the groups. The most notable limitation of this study is the lack of long-term follow-up, as uroflowmetry, PVR, and IPSS data was only collected up to 1 week following stent removal; therefore, the durability of the results are not evident.

The FDA summary reported the majority of adverse events, greater than 75% for both groups, occurred during weeks 1 to 4 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, 2 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 1 week only with a difference of 3 points at that visit is questionable as is the difference in PVR noted up to 4 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 (for example, 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.

In summary, the peer-reviewed medical literature regarding use of temporary prostatic stents for the treatment of urinary obstruction due to BPH and other genitourinary conditions (such as bladder outlet obstruction) consists primarily of small case series, retrospective studies (Roach, 2017), analysis of a BPH database (Tyson, 2012), and review articles. Additional study is needed to determine if use of temporary prostatic stents will result in clinically significant improvement in urinary function and symptom control with less adverse effects, especially in individuals who may be unfit for surgical intervention for BPH or other genitourinary conditions.  

Transurethral Convective Water Vapor Thermal Ablation

Transurethral convective water vapor thermal ablation therapy is being evaluated as a treatment for LUTS due to BPH. The Rezūm System (NxThera, Inc., Maple Grove, MN) received FDA 510(k) designation (K150786) on August 27, 2015 as a sterile water vapor (103oC) system to treat BPH by delivering targeted, controlled doses of stored thermal energy (created with radiofrequency current) directly to the transition zone of the prostate gland. A narrow sheath, similar in shape and size to a cystoscope, is inserted transurethrally and positioned within the prostatic urethra between the bladder neck and the verumontanum. A thin needle is positioned through the urethra into the transition zone, and a short (8-10 second) delivery of water vapor is injected directly into the hyperplastic tissue, retracted, and then repositioned to additional treatment sites as needed. Upon contact with the tissue, the vapor condenses into its liquid state, releasing the stored thermal energy contained within the vapor. This thermal energy is released directly against the walls of the tissue cells within the treatment zone. The treatment can be customized to the shape and location of the gland including the median lobe.

Dixon and colleagues (2015) evaluated the Rezūm System in a series of histological and radiographic studies to determine whether convective thermal energy was capable of rapid and effective ablation of prostate tissue in men with BPH. A total of 7 participants were treated with transurethral intra-prostatic injections of sterile steam under endoscopic visualization followed by previously scheduled open adenectomies. The number of steam injections was determined by prostatic urethral length and presence or absence of a median lobe. Post-procedure, the extirpated adenomas were grossly examined followed by whole mount sectioning and staining with triphenyl-tetrazolium chloride (TTC) to evaluate thermal ablation. Selected areas from the TTC-stained fresh whole mounts of one prostate were then dissected and histological analysis was performed after hematoxylin and eosin staining. After analyzing extirpated tissues from the first 7 participants, an additional 15 participants with clinical BPH were treated followed by gadolinium-enhanced MRI at 1 week to assess volume and location of the ablative lesions. In the first 7 participants, gross examination of TTC-stained tissue showed thermal ablation in the transition zone; and, there was a distinct interface between viable and necrotic prostatic parenchyma. Histopathologic examination revealed TTC staining-outlined necrotic versus viable tissue. Gadolinium-enhanced MRIs demonstrated lesion defects in the next 15 participants at 1 week post-procedure. Coalesced lesions were noted with a mean (SD) lesion volume of 9.6 ± 8.5 cm3. The largest lesion volume was reported as 35.1 cm3. Ablation using vapor was rapid and remained confined to the transition zone, consistent with the thermodynamic principles of convective thermal energy transfer. The authors concluded that thermal ablation was observed in all specimens and that the resulting coalescing ablative lesions, as seen on MRI, were confined to the transition zone. The results of this early study confirming the ablative capabilities of vapor and convective heating on prostate tissue require further investigation to confirm the safety and clinical benefit of prostatic ablation in individuals with BPH.

McVary and colleagues (2016a; 2016b) reported outcomes from a multicenter, randomized controlled study using transurethral prostate convective water vapor thermal energy to treat LUTS associated with BPH. A total of 197 men aged 50 years or older with an IPSS of 13 or greater, maximum flow rate of 15 ml per second or less, and prostate size 30 cc to 80 cc were randomized 2:1 between thermal therapy with the Rezūm System (n=136) and control (n=61). Thermal water vapor was injected into the transition zone and median lobe as needed. The control procedure was rigid cystoscopy with simulated active treatment sounds. The primary endpoint compared a reduction in IPSS at 3 months, with the subjects in the Rezūm group followed for 12 months. Thermal therapy and control IPSS was reported as reduced by 11.2 ± 7.6 and 4.3 ± 6.9, respectively (p<0.0001). Participants in the Rezūm group had an IPSS reduction of 22 points from baseline at 2 weeks (p=0.0006) post-treatment and by 50% or greater at 3, 6 and 12 months (p<0.0001). The peak flow rate increased by 6.2 ml per second at 3 months and was sustained throughout 12 months (p<0.0001). Adverse events were reported as mild to moderate and resolved quickly. In a subset analysis, McVary and colleagues (2016a) evaluated participant satisfaction rates in erectile and ejaculatory function post-treatment with the Rezūm System. Blinded group (active = 136, control = 61) comparison occurred at 3 months and the active arm was followed to 12 months for IPSS, peak flow rate, and sexual function using IIEF and MSHQ-EJD scores. The minimal clinically important difference in erectile function perceived by participants as beneficial was determined for each erectile function severity category. Participants who were not sexually active were excluded from sexual function analysis. No treatment- or device-related de novo erectile dysfunction occurred after Rezūm therapy. The IIEF and MSHQ-EJD scores were not different from the control group at 3 months or from baseline at 1 year. Ejaculatory bother score improved 31% over baseline (p=0.0011). A total of 32% of participants achieved minimal clinically important differences in erectile function scores at 3 months, and 27% at 1 year, including those with moderate to severe erectile dysfunction. Treatment group IPSS and peak flow rates were statistically significant in comparison to controls at 3 months and throughout 1 year (p<0.0001). While convective water vapor thermal therapy provided sustained improvements for 12 months in LUTS and urinary flow while preserving erectile and ejaculatory function, some limitations in the study design and subset analysis are apparent. There were no direct comparisons of convective water vapor thermal therapy with other minimally invasive treatments for LUTS associated with BPH. The study design did not account for confounding factors, such as the existence of other medical conditions in the sample population, including, but not limited to, androgen deficiency, metabolic syndrome, and lifestyle factors.

Roehrborn and colleagues (2017b) reported 2-year outcomes of the multicenter randomized controlled study (McVary, 2016a) plus 1-year results of a crossover trial after transurethral prostate convective water vapor thermal energy treatment with Rezūm to treat LUTS associated with BPH. After unblinding at 3 months, 53 of 61 (86.9%) control group participants who met IPSS and Qmax criteria elected and requalified for crossover to active treatment. Crossover study participants were assessed per protocol at 3 months (n=50), 6 months (n=49), and 12 months (n=45, 84.9%). Per protocol participants were assessed at 3, 6, 12 and 24 months after treatment with Rezūm. The primary efficacy endpoint was a change in IPSS at 24 months. At 3 months (n=134), 6 months (n-129), and 12 months (n=121), per protocol participants treated with Rezūm reported a significant improvement over controls in IPSS and a sustained reduction from baseline to 24 months (n=106 [80.7%] participants) (-51% change; 95% CI, -57 to -45; p<0.0001). Crossover participants experienced improvement in IPSS (p=0.004), Qmax (p<0.0001), and quality of life (p=0.0024) measures after Rezūm therapy compared to after the control procedure. During the 24-month follow-up, 8 participants received secondary treatment, including open prostatectomy (n=1), a second Rezūm procedure (n=3), and TURP (n=4). A total of 9 participants withdrew from the study and 2 participants in the crossover group experienced a total of 3 serious procedure-related adverse events (bladder neck contracture, bladder calculi, and urosepsis). The most common mild to moderate adverse events were dysuria (18.9%) and hematuria (11.3%). The investigators reported that preservation of sexual function in Rezūm-treated participants was sustained in participants after the crossover procedure and throughout the 2-year follow-up.

In summary, additional longer-term data is needed from larger randomized, comparative studies to determine the net health benefit of convective water vapor thermal therapy compared to standard treatments for LUTS associated with BPH.

Other Considerations for Transurethral Convection Water Vapor Thermal Therapy for BPH

The 2018 AUA guideline on Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia includes the following recommendations for use of water vapor thermal therapy for LUTS attributed to BPH:

Water vapor thermal therapy may be offered to patients with LUTS attributed to BPH provided prostate volume <80 g; however, patients should be informed that evidence of efficacy, including longer-term retreatment rates, remains limited (Conditional Recommendation; Evidence Level: Grade C).

Water vapor thermal therapy may be offered to eligible patients who desire preservation of erectile and ejaculatory function (Conditional Recommendation; Evidence Level: Grade C).

Other Treatments for BPH

The earlier AUA’s Guideline on the Management of Benign Prostatic Hyperplasia (BPH) (AUA, 2010) 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. The level of evidence regarding the safety and utility of endoscopic balloon dilation, cryosurgical ablation, and the placement of stents, including a lack of 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).

Surgical and Minimally Invasive Treatments for Genitourinary Conditions Other Than BPH

The efficacy of surgical and minimally invasive procedures including contact laser ablation of the prostate (CLAP), holmium laser procedures, interstitial laser coagulation of the prostate (ILCP), PVP, RFNA/TUNA, transurethral ultrasound guided laser induced prostatectomy (TULIP), TUMT, visually guided laser ablation of the prostate (VLAP), and WIT has not been established as treatment for prostatic or other genitourinary conditions other than BPH. The AUA, American Society for Radiation Oncology (ASTRO), and the Society for Urologic Oncology’s (SUO) Guideline for the Management of Clinically Localized Prostate Cancer (AUA, 2017), the National Cancer Institute’s Prostate Cancer Treatment (PDQ®) (NCI, 2017), and the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology-Prostate Cancer (V2.2017) 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.

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% to 50% of men ages 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.

Outcome Measures to Evaluate BPH Symptoms

A number of health status measures are used to evaluate symptoms relevant to BPH and adverse effects of treatment for BPH, including urinary dysfunction, severity of LUTS, ejaculatory dysfunction, overall sexual health, and overall quality of life. These measures include the AUASI, Benign Prostatic Hyperplasia Impact Index (BPH-II), IPSS, MSHQ-EjD, and the SHIM questionnaire. Please see the Definitions section for a description of each measurement scale or questionnaire as it evaluates symptoms related to BPH.

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.

Other transurethral surgical and minimally invasive treatments for BPH are designed as an alternative to long-term medical therapy with the potential benefits of shorter hospital length of stay and decreased recovery time when compared to TURP. These 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.

American Urological Association /Symptom Index (AUASI): A self-administered, 7-item questionnaire with a final score range of “0” (no symptoms) to “35” (worst symptoms), used to report the severity of lower urinary tract symptoms.

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.

Benign Prostatic Hyperplasia Impact Index (BPH-II): A self-administered, 4-item questionnaire with a final score range of “0” (best) to “13” (worst), used to measure the effect of urinary symptoms on health domains.

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.

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.

Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD): A self-administered questionnaire consisting of a 4-item scale measuring ejaculatory function.

Prostatic urethral lift (PUL): A permanently implanted lift device intended to hold the lateral prostatic lobes apart and create a passage through an obstructed prostatic urethra to improve the voiding channel.

Sexual Health Inventory for Men (SHIM): A self-administered, 5-item questionnaire consisting of a final score range of “1” (worst symptoms) to “25” (fewest symptoms) measuring erectile function.

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.

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.

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 transurethral 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).

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. 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

 

52450

Transurethral incision of prostate [TUIP]

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are also Medically Necessary:

CPT

 

52647

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

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

Laser 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]

53850

Transurethral destruction of prostate tissue; by microwave thermotherapy [TUMT]

53852

Transurethral destruction of prostate tissue; by radiofrequency thermotherapy [when specified as RF needle ablation, RF TUNA, RFNA]

53899

Unlisted procedure, urinary system [when specified as transurethral destruction of prostate tissue: by water-induced thermotherapy (WIT)]

 

 

ICD-10 Procedure

 

0V507ZZ

Destruction of prostate, via natural or artificial opening

0V508ZZ

Destruction of prostate, via natural or artificial opening endoscopic

 

 

ICD-10 Diagnosis

 

N13.8

Other obstructive and reflux uropathy

N32.0

Bladder neck obstruction

N40.0-N40.3

Benign prostatic hyperplasia

R33.8

Other retention of urine

R33.9

Retention of urine, unspecified

R39.11-R39.198

Other 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

 

53899

Unlisted procedure, urinary system [when specified as transurethral balloon dilation of the prostatic urethra]

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are Investigational and Not Medically Necessary:

CPT

 

52441

Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant

52442

Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant

53855

Insertion of a temporary prostatic urethral stent, including urethral measurement

 

 

HCPCS

 

C9739

Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants

C9740

Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants

C9748

Transurethral destruction of prostate tissue; by radiofrequency water vapor (steam) thermal therapy

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When Services are also Investigational and Not Medically Necessary:

CPT

 

37243

Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction [when specified as prostatic arterial embolization]

53852

Transurethral destruction of prostate tissue; by radiofrequency thermotherapy [when specified as transurethral convective water vapor thermal ablation]

55873

Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)

53899

Unlisted procedure, urinary system [when specified as transurethral convective water vapor thermal ablation]

55899

Unlisted procedure, male genital system [when specified as destruction of prostate tissue by transurethral convective water vapor thermal ablation]
Note: Since there is no specific CPT code for transurethral convective water vapor thermal ablation, the unlisted procedure codes 53899 or 55899 would be appropriate. If transurethral convective water vapor thermal ablation is billed with CPT code 53852, as may be advocated by specialty societies, the service would be considered investigational and not medically necessary.

 

 

ICD-10 Diagnosis

 

N13.8

Other obstructive and reflux uropathy

N32.0

Bladder neck obstruction

N40.0-N40.3

Benign prostatic hyperplasia

R33.8

Other retention of urine

R33.9

Retention of urine, unspecified

R39.11-R39.198

Other difficulties with micturition

References

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Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Urological Association (AUA). Clinical guidelines. Available at: http://www.auanet.org/guidelines. Accessed on June 28, 2018.
    • Guideline for the Management of Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline 2017.
    • Guideline on the Management of Benign Prostatic Hyperplasia (BPH). Reviewed and confirmed 2014.
    • Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (2018).
  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 June 28, 2018.
  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. McWilliams JP, Kuo MD, Rose SC, et al. Society of Interventional Radiology position statement: prostate artery embolization for treatment of benign disease of the prostate. J Vasc Interv Radiol. 2014; 25(9):1349-1351.
  7. NCCN Clinical Practice Guidelines in Oncology®. © 2017 National Comprehensive Cancer Network, Inc. Prostate cancer. V.2.2017. February 21, 2017. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on September 28, 2017.
Websites for Additional Information
  1.  National Cancer Institute (NCI). Prostate cancer treatment (PDQ®). March 29, 2018. Available at: http://www.cancer.gov/types/prostate/hp/prostate-treatment-pdq. Accessed on June 28, 2018.
  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 June 28, 2018.
Index

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
ProstaLund CoreTherm System
Prostatron System
Prostiva RF Therapy
Rezūm System
Targis System
The Spanner Temporary Prostatic Stent
TherMatrx Office Thermo Therapy
UroLift System

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

Status

Date

Action

Reviewed

07/26/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale with AUA guideline recommendations for minimally invasive surgical techniques for management of LUTS attributed to BPH, References, and Websites for Additional Information sections.

Revised

11/02/2017

MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Administrative updates to the MN, NMN, and INV and NMN statements (removed abbreviations). Updated Description, Rationale, References, and Websites for Additional Information sections.  Updated Coding section with 01/01/2018 HCPCS changes.

Reviewed

05/04/2017

MPTAC review. Updated Rationale, References, and Websites for Additional Information sections.

Revised

11/03/2016

MPTAC review. Clarification to the NMN statement. Revised INV and NMN statement for BPH, removing high-intensity focused ultrasound (HIFU) ablation from the document, with procedure being added to rescoped document, MED.00057. Updated Description, Rationale, Background, Definitions, Coding, References, and Websites for Additional Information sections.

Revised

08/04/2016

MPTAC review. Updated formatting in Position Statement section. Updated the Position Statement for treatments considered INV and NMN for BPH, adding transurethral convective water vapor thermal ablation (Rezūm System). Updated Description, Rationale, Background, References, Websites for Additional Information, and Index sections. Updated Coding section to include ICD-10-CM changes effective 10/01/2016 and removal of ICD-9 codes.

Reviewed

08/06/2015

MPTAC review. Updated Rationale, Definitions, References, and Websites for Additional Information sections.

Reviewed

11/13/2014

MPTAC review. Updated Description, Rationale, References, and Websites for Additional Information sections. Other format changes throughout document. Updated Coding section with 01/01/2015 CPT changes.

Revised

02/13/2014

MPTAC review. Combined existing investigational and not medically necessary statements for cryosurgical ablation and HIFU, adding new criteria for prostatic artery embolization (PAE) and prostatic urethral lift (PUL) for the treatment of symptomatic BPH. Updated and reordered Rationale section. Updated Background, Definitions, References, Websites for Additional Information, and Index sections. Updated Coding section to include 04/01/2014 HCPCS changes.

Reviewed

02/14/2013

MPTAC review. Updated Rationale, Coding, References, Websites for Additional Information, and Index.

Reviewed

02/16/2012

MPTAC review. Updated Rationale, Discussion, Coding, References, Websites for Additional Information, and Index.

Reviewed

05/19/2011

MPTAC review. Updated Rationale, Background, Definitions, References, and Index. Added section: Websites for Additional Information.

Reviewed

05/13/2010

MPTAC review. Updated Rationale, Coding, and References.

 

01/01/2010

Updated Coding section with 01/01/2010 CPT changes; removed CPT 0084T deleted 12/31/2009.

Reviewed

05/21/2009

MPTAC 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 procedures and non-contact laser ablation of the prostate to the VLAP statement. Updated Rationale, Discussion, Definitions, Index, and References.

 

01/01/2009

Updated Coding section with 01/01/2009 CPT changes; removed CPT 53853 deleted 12/31/2008.

Revised

05/14/2008

MPTAC 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.

Revised

02/21/2008

MPTAC 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.

 

01/01/2008

Updated 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.

Revised

03/08/2007

MPTAC review. Position Statement change, medically necessary criteria revised. Rationale and References updated.

Reviewed

03/23/2006

MPTAC review. Updated References.

 

01/01/2006

Updated Coding section with 01/01/2006 CPT/HCPCS changes.

 

11/18/2005

Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

Revised

04/28/2005

MPTAC review.  Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations Last Review Date Document Number

Title

Anthem, Inc. 01/13/2005 SURG.00028

Surgery for Benign Prostatic Hypertrophy (BPH)

WellPoint Health Networks, Inc.

12/02/2004

3.08.02

Treatment of Benign Prostatic Hypertrophy

 

12/02/2004

3.08.05

Temporary Prostatic Stent