Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2015024
Category:	Surgery
Initiated:	August 2015
Last Review:	August 2023

Ablative Procedures for Benign Prostatic Hyperplasia (BPH) and Minimally Invasive Benign Prostatic Hyperplasia Treatments

Description:

Benign Prostatic Hyperplasia

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

Two scores are widely used to evaluate BPH-related symptoms. The American Urological Association Symptom Index (AUASI) is a self-administered 7-item questionnaire assessing the severity of various urinary symptoms (Barry, 1992). Total AUASI scores range from 0 to 35, with overall severity categorized as mild (≤7), moderate (8-19), or severe (20-35) (Sarma, 2012). The International Prostate Symptom Score incorporates the questions from the AUASI and a quality of life question or “Bother score (O’Leary 2005)”.

Management of BPH

Evaluation and management of BPH includes evaluation for other causes of lower urinary tract dysfunction (eg, prostate cancer). Symptom severity and the degree that symptoms are bothersome determine the therapeutic approach.

Medical Therapy

A discussion about medical therapy is generally indicated for patients with moderate-to-severe symptoms (eg, AUASI score, ≥8), bothersome symptoms, or both. Available medical therapies for BPH-related lower urinary tract dysfunction include α-adrenergic blockers (eg, alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (eg, finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents (eg, darifenacin, solifenacin, oxybutynin), and phosphodiesterase-5 inhibitors (eg, tadalafil) (Sarma, 2012).

Surgical and Ablative Therapies

Various surgical or ablative procedures are used to treat BPH. Transurethral resection of the prostate (TURP) is generally considered the reference standard for comparisons of BPH treatments (AUA, 2010). In the perioperative period, TURP is associated with risks of any operative procedure (eg, anesthesia risks, blood loss). Although short-term mortality risks are generally low, 1 large prospective study with 10,654 patients reported the following short-term complications: “failure to void (5.8%), surgical revision (5.6%), significant urinary tract infection (3.6%), bleeding requiring transfusions (2.9%), and transurethral resection syndrome (1.4%) (Reich, 2008)”. Incidental carcinoma of the prostate was diagnosed by histologic examination in 9.8% of patients. In the longer term, TURP is associated with risk of sexual dysfunction and incontinence.

Several minimally invasive prostate ablation procedures have also been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate.

Prostatic Urethral Lift

The prostatic urethral lift procedure involves placement of 1 or more implants in the lateral lobes of the prostate using a transurethral delivery device. The implant device is designed to retract the prostate to allow expansion of the prostatic urethra. The implants are retained in the prostate to maintain an expanded urethral lumen.

One device, the NeoTract UroLift® System (NeoTract, Pleasanton, CA), has clearance for marketing by the U.S. Food and Drug Administration (FDA; see Regulatory Status section). The device has 2 main components: the delivery device and the implant. Each delivery device comes preloaded with 1 UroLift implant.

Water Vapor Thermal Therapy (e.g., Rezum System) and Transurethral Waterjet Ablation (e.g., Aquabeam, Aquablation)

Transurethral water vapor thermal therapy and aquablation have been investigated as minimally invasive alternatives to transurethral resection of the prostate. Transurethral water vapor thermal therapy uses convective radiofrequency (RF) water vapor energy to ablate prostate tissue. Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra.

Prostatic Artery Embolization (PAE)

Outcome Measures Used in Evaluating 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, ejaculatory dysfunction, overall sexual health, and overall quality of life. Some validated scales are shown below.

Health Status Measure Relevant to Benign Prostatic Hypertrophy

Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EiD) (Rosen, 2007)

Outcome Evaluated: Ejaculatory function

Description: Patient-administered, 4-item scale

Sexual Health Inventory for Men (SHIM) (Cappelleri, 2005)

Outcome Evaluated: Erectile function

Description: Patient-administered, 5-item scale, final score range 1-25

American Urological Association Symptom Index (AUASI) (Sarma, 2012; Barry, 1995)

Outcome Evaluated: Severity of lower urinary tract symptoms

Description: Patient-administered, 7-item scale, final score range, 0-35

Clinically Meaningful Minimum of 3-point change difference

International Prostate Symptom Score (IPSS) (O”Leary, 2005)

Outcome Evaluated: Severity of lower urinary tract symptoms

Description: Patient-administered, 8-item scale

Benign Prostatic Hyperplasia Impact Index (BPH-II) (AUA, 2010; Barry, 1995)

Outcome Evaluated: Effect of urinary symptoms on health domains

Description: Patient-administered, Leary-item scale, final score range, 0-13 Clinically Meaningful Minimum of 0.4-point change difference

Regulatory Status

One implantable transprostatic tissue retractor system has been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. In December 2013, the NeoTract UroLift® System UL400 (NeoTract, Pleasanton, CA) was cleared (after receiving clearance through FDA’s de novo classification process in March 2013; K130651/DEN130023). In March 2016, FDA determined that the UL500 was substantially equivalent to existing devices (UL400) for the treatment of symptoms of urinary flow obstruction secondary to benign prostatic hyperplasia in men age 50 years and older. In 2017, the FDA expanded the indication for the UL400 and UL500 to include lateral and median lobe hyperplasia in men 45 years or older. An additional clearance in 2019 (K193269) modified one contraindication from men with prostate volume of >80 cc to men with prostate volume of >100 cc. FDA product code: PEW.

In September 2016, The Rezum System (NxThera. Inc. acquired by Boston Scientific in 2018) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K150786). The FDA determined that this device was substantially equivalent to existing devices (Medtronic Prostiva devices). Rezum is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia. It is indicated for men > 50 years of age with a prostate volume > 30cm3 and < 80 cm3. The Rezum System is also indicated for the treatment of prostate with hyperplasia of the central zone and/or a median lobe.

In April 2017, the Aquabeam System (Procept Robotics Corporation) was cleared for marketing by the FDA through the 513 (F)(2) (de novo) classification process (Den170024). The device is intended for the resection and removal of prostate tissue in males suffering from LUTS due to benign prostatic hyperplasia.

In June 2017, the U.S. 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.

Coding

There are specific CPT/HCPCS codes for prostatic urethral lift procedure:

52441 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant

52442 each additional permanent adjustable transprostatic implant (List separately in addition to code for primary procedure)

C9739 Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants

C9740 Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants

Note: HCPCS codes C9739 and C9740 are not accepted for processing claims.

There are specific CPT codes for water vapor thermal therapy (e.g., Rezum System):

53854 Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy

0582T - Transurethral ablation of malignant prostate tissue by high-energy water vapor thermotherapy, including intraoperative imaging and needle guidance

There is a specific CPT code for the aquablation procedure (e.g., Aquabeam):

0421T Transurethral waterjet ablation of prostate, including control of post-operative bleeding, including ultrasound guidance, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included when performed)

There is not a specific code for prostatic artery embolization (PAE). The following codes may be used to report PAE:

36245 Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower extremity artery branch, within a vascular family

36246 Selective catheter placement, arterial system; initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family

36247 Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family

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

75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation

Policy/
Coverage:

Effective September 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

The use of prostatic urethral lift in individuals with moderate-to-severe lower urinary tract obstruction due to benign prostatic hyperplasia meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when all of the following criteria are met:

Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months; AND
Prostate gland volume is less than or equal to 80 mL; AND
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND
Patient does not have any of the following:

Urinary retention OR
Urinary tract infection OR
Prostatitis (within past year); AND

Patient has had appropriate testing to exclude diagnosis of prostate cancer; AND
Patient does not have a known allergy to nickel, titanium, or stainless steel; AND
Procedure is performed in either an outpatient facility, ambulatory surgery center, or office setting.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of prostatic urethral lift in any other situation, including repeat procedures does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, the use of prostatic urethral lift in any other situation, including repeat procedures is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

The use of greater than 8 total implants for a prostatic urethral lift procedure does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, the use of greater than 8 total implants for a prostatic urethral lift procedure is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Transurethral convective water vapor thermal ablation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, transurethral convective water vapor thermal ablation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Prostatic artery embolization does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, prostatic artery embolization is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

The use of transurethral waterjet ablation (e.g., Aquablation) as a treatment of benign prostatic hyperplasia does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, the use of transurethral waterjet ablation (e.g., Aquablation) as a treatment of benign prostatic hyperplasia is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Ablative techniques for the treatment of benign prostatic hyperplasia, except for those identified as a covered service, do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, ablative techniques for the treatment of benign prostatic hyperplasia, except for those identified as a covered service, are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective prior to September 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months; AND
Prostate gland volume is less than or equal to 80 mL; AND
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND
Patient does not have any of the following:

Urinary retention OR
Urinary tract infection OR
Prostatitis (within past year); AND

Patient has had appropriate testing to exclude diagnosis of prostate cancer; AND
Patient does not have a known allergy to nickel, titanium or stainless steel; AND
Procedure is performed in either an outpatient facility, ambulatory surgery center, or office setting.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of prostatic urethral lift in any other situation, including repeat procedures does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of prostatic urethral lift in any other situation, including repeat procedures is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

The use of greater than 8 total implants for a prostatic urethral lift procedure does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of greater than 8 total implants for a prostatic urethral lift procedure is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Transurethral convective water vapor thermal ablation does not meet member benefit certificate primary coverage criteria and is not covered. For members with contracts without primary coverage criteria, transurethral convective water vapor thermal ablation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Prostatic artery embolization does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.

For members with contracts without primary coverage criteria, prostatic artery embolization is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

The use of transurethral waterjet ablation (e.g., Aquablation) as a treatment of benign prostatic hyperplasia does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, the use of transurethral waterjet ablation (e.g., Aquablation) as a treatment of benign prostatic hyperplasia is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective January 2021 to November 20, 2021

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months; AND
Prostate gland volume is ≤80 mL; AND
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND
Patient does not have any of the following:

Urinary retention OR
Urinary tract infection OR
Prostatitis (within past year); AND

Patient does not have prostate-specific antigen level ≥3 ng/mL, or has had appropriate testing to exclude diagnosis of prostate cancer; AND
Procedure is performed in either an outpatient facility, ambulatory surgery center, or office setting.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Prostatic artery embolization does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.

Effective Prior to January 2021

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months; AND
Prostate gland volume is ≤80 mL; AND
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND
Patient does not have any of the following:

Urinary retention OR
Urinary tract infection OR
Prostatitis (within past year); AND

Patient does not have prostate-specific antigen level ≥3 ng/mL, or has had appropriate testing to exclude diagnosis of prostate cancer; AND
Procedure is performed in either an outpatient facility or ambulatory surgery center.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Prostatic urethral lift performed in an office setting does not meet member benefit certificate primary coverage criteria and is not covered. For members with contracts without primary coverage criteria, prostatic urethral lift performed in an office setting is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Prostatic artery embolization does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.

Effective Prior to October 2020

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months; AND
Prostate gland volume is ≤80 mL; AND
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND
Patient does not have urinary retention, urinary tract infection, or recent prostatitis (within past year); AND
Patient does not have prostate-specific antigen level ≥3 ng/mL, or has had appropriate testing to exclude diagnosis of prostate cancer; AND
Procedure is performed in either an outpatient facility or ambulatory surgery center.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Prostatic artery embolization does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.

Effective Prior to August 2020

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months; AND
Prostate gland volume is ≤80 mL; AND
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND
Patient does not have urinary retention, urinary tract infection, or recent prostatitis (within past year); AND
Patient does not have prostate-specific antigen level ≥3 ng/mL, or has had appropriate testing to exclude diagnosis of prostate cancer; AND
Procedure is performed in either an outpatient facility or ambulatory surgery center.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of prostatic urethral lift does not meet member benefit certificate primary coverage criteria in any other situations. For members with contracts without primary coverage criteria, the use of prostatic urethral lift in any other situation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Prostatic artery embolization does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness and is not covered.

Effective Prior to October 2019

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months; AND
Prostate gland volume is ≤80 mL; AND
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND
Patient does not have urinary retention, urinary tract infection, or recent prostatitis (within past year); AND
Patient does not have prostate-specific antigen level ≥3 ng/mL, or has had appropriate testing to exclude diagnosis of prostate cancer; AND
Procedure is performed in either an outpatient facility or ambulatory surgery center.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Effective Prior to March 2019

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Patient has persistent or progressive lower urinary tract symptoms or is unable to tolerate medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months; AND
Prostate gland volume is ≤80 mL; AND
Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND
Patient does not have urinary retention, urinary tract infection, or recent prostatitis (within past year); AND
Patient does not have prostate-specific antigen level ≥3 ng/mL, or has had appropriate testing to exclude diagnosis of prostate cancer; AND
Procedure is performed in either an inpatient or outpatient facility or ambulatory surgery center.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

EFFECTIVE PRIOR TO MAY 2018

The prostatic urethral lift procedure for all indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members without primary coverage criteria, the prostatic urethral lift procedure is considered investigational for all indications. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:

“Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com”

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Systematic Reviews

Several systematic reviews on prostatic urethral lift (PUL) have been published. They include a similar set of trials and noncomparative studies.

In 2015, Perera et al reported on results of a systematic review and meta-analysis (Perera, 2015) of studies reporting outcomes after the PUL procedure, which included 7 prospective cohort studies, (Garrido, 2013; Hoffman, 2012; Shore, 2014; McNicholas, 2013; Chin, 2012; Woo, 2012; Woo, 2011) a crossover study (Cantwell, 2014), and the LIFT RCT (Roehrborn , 2013;, McVary, 2014). The pooled standardized mean gain estimates for prostate symptoms scores (International Prostate Symptom Score [IPSS], Benign Prostatic Hyperplasia Impact Index [BPH-II]), and sexual health scores used responses from 452 to 680 patients. The standardized mean gain for prostatic symptoms scores ranged from -1.3 (95% confidence interval [CI], -1.4 to -1.2) to -1.6 (95% CI, -1.7 to -1.3), which translated into a clinically meaningful improvement. The standardized mean gain for sexual health scores ranged from 0.3 (95% CI, 0.2 to 0.4) to 0.4 (95% CI, 0.3 to 0.5), suggesting a small improvement.

In 2015, Shore performed a systematic review of UroLift studies, which included the LIFT RCT (Roehrborn, 2013; Roehrborn, 2015; McVary, 2014), a crossover study (Cantwell, 2014), and 4 prospective cohort studies (Garrido Abad, 2013; Chin, 2012; Woo, 2012; McNicholas, 2013) (Shore, 2015). Only data that showed absolute change, supported by a 95% CI or standard deviation, was included in the weighted analysis. Reviewers reported that, from 0.5 to 1.5 months to 2 years, mean peak urinary flow rate (Qmax) increased from 3.3 to 4.15, IPSS improved from -4.5 to -9.2 relative to baseline, quality of life improved from -1.2 to -2.2 relative to baseline, and BPH-II scores improved from -0.1 to -3.8 relative to baseline. Changes in postvoid residual volume were not statistically significant.

In 2016, Jones et al performed a systematic review of UroLift studies with at least 12 months of follow-up (Jones, 2016). Seven studies were identified, which included 4 noncomparative studies (Woo, 2011; Chin, 2012; McNicholas, 2013; Bozkurt, 2016), a crossover study (Cantwell, 2014), and 2 RCTs [LIFT (Roehrborn, 2013) and BPH6 (Sonksen, 2015) ]. Reviewers included data from 440 patients. Only the data from men in the UroLift arms of these RCTs were included. Results were combined to create summaries, but the meta-analytic methods used to combine the data were not described, and precision estimates were not given. The authors reported that 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 International Index of Erectile Function score improved from 17.7 to 18.2. The most frequent complications reported were dysuria, hematuria and pelvic pain.

The National Institute for Health and Care Excellence (NICE) published a technical guidance on prostatic lift procedures in 2016 (Ray, 2016). NICE performed a literature search and data synthesis to support the development of the guidance. Studies selected were the same studies included in Perera, et al (2015), except for the exclusion of Hoffman et al (2012) and the inclusion of Garrido Abad et al (2013) in the analysis. Comparators for the review were transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP). When the literature search was performed, there were no studies directly comparing PUL with either TURP or HoLEP. Therefore NICE extracted data from a TURP vs HoLEP systematic review to perform a “pragmatic indirect comparison” of these comparators with prostatic lift procedures. Reviewers concluded that while PUL provided a significant improvement in IPSS, BPH-II, and quality of life, those improvements were smaller than those seen with TURP or HoLEP; however, it should be noted that the PUL procedure was associated with a slight improvement in erectile or ejaculatory function.

Randomized Controlled Trials

Two RCTs of PUL have been performed. A brief description of each trial is provided in the following section.

BPH6 Study

In 2015, Sonksen et al reported on results of a multicenter RCT comparing the PUL procedure with TURP among individuals ages 50 and older with lower urinary tract symptoms, secondary to benign prostatic obstruction (Sonksen, 2015). Eligible patients had an IPSS above 12, a Qmax of 15 mL/s or less for a 125-mL voided volume, a postvoid residual volume less than 350 mL, and prostate volume of 60 cm3 or less on ultrasound. Patients were excluded if there was median lobe obstruction in the prostate or signs of active infection. The study used a novel composite end point, referred to as the BPH6, which included the following criteria:

Lower urinary tract symptom relief: Reduction in IPSS by ≥30% within 12 months, relative to baseline

Recovery experience: Self-assessed by patients as ≥70% within 1 month, using a visual analog scale

Erectile function: Reduction in Sexual Health Inventory for Men (SHIM) score by ≤6 points within 12 months, relative to baseline

Ejaculatory function: Emission of semen as assessed by question 3 in the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)

Continence preservation: Incontinence Severity Index ≤4 points at all follow-up visits

Safety: No treatment-related adverse events exceeding grade 1 on the Clavien-Dindo classification system at time or procedure or any follow-up.

Patients were considered treatment responders if they met all 6 composite criteria. While this composite end point had not been previously validated, core components of the composite score have been independently validated in a clinical setting. The trial used a non-inferiority design with a margin of 10% for the primary end point, BPH6. Study investigators modified two of the original end point definitions in the study’s analysis, including changing the sexual function element assessment from a single time point (12 months) to assess sustained effects during 12 months of follow-up; and lowering the threshold of quality of recovery on visual analog scale from 80 to 70.

Ninety-one patients were randomized to TURP (n=45) or PUL (n=46). Ten patients in the TURP group and 1 patient in the PUL group declined treatment, leaving an analysis group of 80 subjects. The analysis was per-protocol, including 35 in the TURP group and 44 in the PUL group (87% of those randomized; 1 patient was excluded for violation of the active urinary retention exclusion criterion). Groups were similar at baseline, except for the MSHQ-EjD Function score. For procedure recovery, 82% of the PUL group achieved the recovery end point by 1 month compared with 53% of the TURP group (p=0.008). For the study’s primary outcome, the proportion of participants who met the original BPH6 primary end point was 34.9% for the PUL group, and 8.6% for the TURP group (noninferiority p<0.001; superiority p=0.006). The modified BPH6 primary end point was met by 52.3% of the PUL group and 20.0% of the TURP group (noninferiority p<0.001; superiority p=0.005). Both groups demonstrated improvements over IPSS, IPSS quality of life score, BPH-II score, and Qmax over time, as described in Table 3. There were 60 grade 1 adverse events in 30 (68%) PUL patients and 79 adverse events in 26 (74%) TURP patients. The number of patients experiencing grade 2 and 3 adverse events was similar between groups. Intention-to-treat analyses were not reported.

Gratzke et al (2017) reported on 2-year results from BPH6.31 Two additional patients were excluded from analysis: 1 TURP patient who discontinued participation; and 1 PUL patient who had a protocol violation. Composite scores for the 2 groups were not reported in this study. Both groups continued to show significant improvements in IPSS score, IPSS quality of life, BPH-II score, and Qmax during the 2-year follow-up. Six (14%) PUL patients and 2 (6%) TURP patients had secondary treatment (PUL, intradetrusor botulinum toxin, laser or TURP procedure), showing moderate durability over 2 years.

Subsection Summary: BPH6 Study

In the BPH6 study, PUL was both noninferior (p<0.001) and superior (p=0.005) to TURP for the study’s composite end point. This end point was calculated using the concurrent achievement of validated measures of symptoms and complications and is sufficient to describe patient health outcomes. TURP was associated with greater improvements in urinary tract obstruction symptom outcomes and with greater declines in ejaculatory function compared with PUL.

LIFT Study

In 2013, Roehrborn et al reported results of the pivotal LIFT study, an RCT comparing prostatic urethral lift with sham control among 206 men aged 50 and older with lower urinary tract symptoms secondary to BPH (Roehrborn, 2013). Eligible patients had an American Urological Association Symptom Index (AUASI) of 13 or greater, Qmax of 12 mL/s or less for a 125-mL voided volume, and a prostate volume between 30 and 80 mL. Patients were excluded if there was median lobe obstruction in the prostate, postvoid obstruction of more than 250 mL, or signs of active infection. Patients underwent washout of BPH mediations before enrollment; the washout period was 2 weeks for alpha blockers and 3 months for 5 alpha reductase inhibitors. Patients were randomized to prostatic urethral lift (n=140) or sham control (n=66) and evaluated at 3 months postprocedure for the study’s primary efficacy end point. After that, all patients were unblinded and sham control patients were permitted to undergo the prostatic urethral lift procedure. Fifty-three control subjects eventually underwent a prostatic urethral lift procedure. Analysis was intention-to-treat. The study met its primary efficacy end point that the reduction in AUASI score at 3 months postprocedure was at least 25% greater after the prostatic urethral lift than that seen with sham (p=0.003). The AUASI score decreased from 24.4 at baseline to 18.5 at 3-month follow-up for sham control patients and from 22.2 at baseline to 11.2 at 3-month follow-up for prostatic urethral lift patients. The 3-month change in Qmax was 4.28 mL/s for prostatic urethral lift patients and 1.98 mL/s for sham control patients (p=0.005). Compared with sham control patients, prostatic urethral lift patients had greater decreases in quality of life scores (note that specific quality of life scoring device was not specified) and BPH-II score. Nine serious adverse events in 7 patients were reported in the prostatic urethral lift group and 1 serious adverse event was reported in the sham group during the first 3 months of follow-up.

McVary et al reported on sexual function outcomes in a subset of patients from the L.IFT study (McVary, 2014). At baseline, 53 (38%) prostatic urethral lift subjects and 23 (53%) sham control subjects were sexually inactive or had severe erectile dysfunction and were censored from the primary sexual function analysis. Scores on the SHIM and MSHQ-EjD Function scale and the MSHQ-EjD Bother scale did not differ significantly between groups.

In 2014, Cantwell et al reported on the outcomes for the 53 subjects in the LIFT sham control group who underwent prostatic urethral lift after unblinding at 3 months postprocedure (Cantwell, 2014). Crossover (unblinded) patients had a change in IPSS score from 23.4 to 12.3 at 3 months postprocedure compared with the change in IPSS score from 25.2 to 20.2 at 3 months after the sham procedure. Subjects had greater improvements in BPH-II score in the crossover period than in the sham period (-3.3 vs -1.9, p=0.024), but did not have significant differences in improvement in Qmax. Change in sexual function scores did not differ significantly after sham procedure compared with after active procedure.

Rukstalis et al (2016) reported on 24-month outcomes for 42 of the 53 participants in the LIFT sham group who underwent PUL after unblinding.33 During the 24 months, 4 patients were known to have had TURP, and 1 patient required additional PUL implants. The change in IPSS from baseline to 24 months was -9.6 (-35%; 95% CI, NR; p<0.001) and there were significant score improvements in Qmax, BPH-II scores, and quality of life. There were no significant changes compared with baseline for SHIM scores; however, MSHQ-EjD scores improved by 41% (p<0.001).

In 2015, Roehrborn et al reported 3-year results from patients randomized to prostatic urethral lift in the LIFT study (Roehrborn, 2015). After exclusion of 11 subjects who were lost to follow-up, 36 subjects who either had missing data, protocol deviations, medication treatment for BPH, or other prostate procedures, and 15 subjects who underwent surgical retreatment for lower urinary tract symptoms (6 with repeat prostatic urethral lift procedures, 9 with TURP or laser vaporization), the 3-year effectiveness analysis included 93 subjects. For subjects included in the follow-up data, change in IPSS score was -8.83 (95% CI, -10.35 to -7.30, p<0.001). Significant improvements were also reported for quality of life score, BPH-II score, and Qmax. Sexual function was unchanged. Implants were removed from 10 participants.

In 2016, Roehrborn et al reported on 4-year results from patients randomized to PUL in the LIFT study.34 Of the 140 originally randomized patients, 32 were lost by the 4-year follow-up visit (six losses were deaths). Of the remaining 108 patients for whom data were available, an additional 29 patients were excluded from analysis for BPH retreatment or protocol deviations. For the 79 (56%) of the 140 subjects 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 (vs baseline) were also reported for scores relating to quality of life, BPH-II, and Qmax. Authors reported that 14% “of the 140 originally enrolled” participants had surgical retreatment at some point during the 4 years; however, the 4-year follow-up included 79 patients, so the denominator for the 14% is not clear, and estimated retreatment rates are likely underestimated since individuals lost to follow-up could also have received retreatment. Attributes of patients who received retreatment were not analyzed. SHIM scores did not differ statistically from baseline.

Roehrborn et al (2017) reported on 5-year results from patients randomized to PUL in the LIFT study.32 The authors reported 2 analyses. The first was called a per-protocol analysis, which censored patients who had additional BPH procedures, started a BPH medication or had a protocol deviation. A second analysis was called intention-to-treat analysis which used last-observation carried forward to impute values that were censored in the per-protocol analysis. While there were 104 participants with 5-year data, only 72 patients were included in the per protocol analysis after exclusion for protocol violations, additional BPH procedures, or treatment with BPH medication In the intention-to-treat analysis, change in IPSS was -7.85 at 5 years (-35%; 95% CI, -41% to -29%; p<0.001). In the per-protocol analysis, change in IPSS was -7.56 at 5 years (-35.9%; 95% CI, -44% to -27%). Significant improvements, when compared with baseline, continued to be reported for scores associated with quality of life, Qmax, and BPH-II.

Subsection Summary: LIFT Study

The LIFT RCT compared PUL with a sham procedure in individuals who were washed out of BPH medications before enrollment. The PUL procedure was associated with greater improvements in lower urinary tract symptoms compared with sham; additionally, the PUL procedure was found to have not worsened sexual function after 3 months of follow-up. After 3 months, patients were given the option to have PUL surgery and about 80% of the sham patients had PUL. Functional improvements, when compared with baseline, appear durable in patients over 2 years and are consistent with the BPH6 study. Follow-up over 3 to 5 years was notable for a high number of patients who were either excluded or lost.

Section Summary: Randomized Controlled Trials

The BPH6 study demonstrated that PUL is noninferior to TURP when assessed by a composite score, which reflects concurrent improvements in validated scales of symptoms, safety, and sexual function. These findings are reflected in analysis of the individual aspects of the composite score. PUL demonstrates measurable improvements in urinary symptoms to 2 years, and is superior to TURP in preserving sexual function. These findings were confirmed in the LIFT study, which compared PUL with a sham treatment. Prior to crossover at 3 months, patients were found to have greater improvement in urinary symptoms and preserved sexual function relative to patients receiving sham treatment. After 3 months, 80% of patients who had received a sham treatment chose to have the PUL procedure. Patients treated with PUL had improvement of urinary symptoms with preservation of sexual function, consistent with the BPH6 study. These findings were preserved in a subset of patients over 3 to 5 years; there was a high number of patients who were either excluded or lost to follow-up during this time.

SUMMARY OF EVIDENCE

For individuals who have lower urinary tract obstruction symptoms (due to BPH) and receive a PUL, the evidence includes systematic reviews, randomized controlled trials, and noncomparative studies. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. One randomized controlled trial, the BPH6 study, compared the PUL procedure with transurethral resection of the prostate and reported that the PUL procedure was noninferior for the study’s composite end point, which required concurrent fulfilment of 6 independently validated measures of symptoms, safety, and sexual health. While transurethral resection of the prostate was superior to PUL in managing lower urinary tract symptoms, PUL did provide significant symptom improvement over 2 years. PUL was further superior to transurethral resection of the prostate in preserving sexual function. These findings were corroborated by another randomized controlled trial, entitled the LIFT study, which compared PUL with sham control. Patients underwent washout of BPH medications before enrollment. LIFT reported that patients with the PUL procedure, compared with patients who had sham surgery and no BPH medication, had greater improvements in lower urinary tract symptoms without worsened sexual function at 3 months. After 3 months, patients were given the option to have PUL surgery; 80% of the patients with sham procedures chose that option. Publications from this trial reported that functional improvements were durable over 3-, 4-, and 5-year follow-ups in a subset of patients treated with PUL; there was a high number of exclusions and loss to follow-up in that group. The evidence is sufficient to determine the effects of the technology on health outcomes.

2019 Update

Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

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 (103 o C) 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.

In 2015, Dixon and colleagues 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 (Dixon, 2015). 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 cm 3 . The largest lesion volume was reported as 35.1 cm 3 . 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 et al in 2016 reported outcomes from a multicenter, randomized controlled study using transurethral prostate convective water vapor thermal energy to treat LUTS associated with BPH (McVary, 2016a; McVary, 2016b). 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 evaluated participant satisfaction rates in erectile and ejaculatory function post-treatment with the Rezūm System (McVary, 2016a). 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.

In 2017, Roehrborn et al reported 2-year outcomes of the multicenter randomized controlled study 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 (Roehrborn, 2017b). 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 (AUA, 2018):

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) 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, 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 4 th International Consultation on BPH has rated balloon dilation as an unacceptable treatment option since 1995 (Denis, 1998).

In a 2018 Hayes Health Technology Brief, the authors report “a very-low-quality body of evidence suggesting that the Rezum System may improve LUTS associated with BPH. However, substantial uncertainty remains regarding the comparative effectiveness and safety due to a lack of comparative studies, as well as limited long-term evidence regarding the durability and safety of this treatment”.

At this time there is insufficient evidence in the peer-reviewed scientific evidence comparing water vapor thermal therapy (e.g., Rezum System) to other treatment options for BPH. Water vapor thermal therapy (e.g., Rezum System) and its role in the treatment of BPH has not yet been established.

October 2019 Update

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. 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.

The published literature on PAE has been summarized in systematic reviews and meta-analyses (Jiang, 2019; Malling, 2019; Shim, 2017). Malling reviewed controlled and uncontrolled studies on PAE for BPH that had at least 10 participants and at least 6 months of follow-up (Malling, 2019). A total of 13 studies met the review's eligibility criteria, including 2 randomized controlled trials (RCTs). One RCT had only 2 participants and the other included 114 individuals (Carnevale, 2016; Gao, 2014). The primary outcome of interest was mean change in the International Prostate Symptom Score (IPSS). In a pooled analysis of symptom improvement at 12 months among individuals receiving PAE, the mean reduction (indicating symptom improvement) in IPSS was -16.2 points (95% confidence interval [CI], -18.3 to -14.0). Secondary outcomes, including quality of life and prostate volume, also improved after PAE. The meta-analysis is limited by lack of comparative analysis and the literature on PAE is limited by the small number of comparative studies.

The meta-analysis by Jiang focused on studies comparing PAE to TURP and evaluated short-term outcomes. Four studies were included in the review, the 2 RCTs mentioned above as well as 2 comparative observational studies (Jiang, 2019). In a pooled analysis of data from 2 studies, there was no significant difference in post-operative IPSS. The post-operative peak flow rate (Qmax) was significantly higher in the TURP group than the PAE group. Similarly, the post-operative prostate volume and quality of life improved significantly more in the TURP group. Data from 2 studies found no statistically significant differences in complications in the 2 groups.

The RCT by Gao included individuals with lower urinary tract symptoms (LUTS) due to BPH who had an IPSS score greater than 7, a prostate volume of 20-100 mL and peak urinary flow of less than 15 mL per second. A total of 114 individuals met the eligibility criteria and were randomized to PAE (n=57) or TURP (n=57) (Gao, 2014). Participants were followed for a mean of 22.4 months. Efficacy outcomes included IPSS, quality of life, peak urinary flow and post-voiding residual urine volume. At the 1- and 3-month follow-ups, there was significantly greater improvement in these outcomes in the TURP group. At all time-points, there was significantly greater reduction in prostate volume in the TURP group. A significantly higher percentage of individuals in the PAE group had complications; most of these were minor complications. In the PAE group, there were 22 (38.6%) minor complications and 8 (14%) major complications whereas in the TURP group, there were 13 (22.8%) minor complications and 4 (7%) major complications. Technical and clinical treatment failure were included in the calculation of major complication.

A randomized non-inferiority trial was published by Abt and colleagues in 2018. The study included 103 individuals with refractory LUTS due to BPH who were randomized to undergo PAE (n=48) or TURP (n=51). Non-inferiority for the primary outcome was defined as less than a 3 point difference in IPSS improvement at 12 weeks. From baseline to 12 weeks, change in the IPSS was -9.23 pints after PAE and -10.77 after TURP. Thus, non-inferiority of PAE to TURP was not established. Functional outcomes at 12 weeks favored the TURP group. The risk of one or more treatment-related adverse events was similar in the 2 groups but more individuals in the TURP group had 2 or more treatment-related adverse events.

There are a number of uncontrolled studies evaluating PAE for treatment of BPH. One of the larger series was published by Pisco and colleagues in 2016. 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, post-void residual urine volume (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.

PAE for symptomatic BPH has been assessed in a number of case series and single-center studies, mainly with small sample sizes. These studies evaluated measures of clinical symptom improvement, laboratory and urodynamic findings, use of different PVA particle sizes, clinical outcomes comparing unilateral to bilateral PAE, and quality of life measures (Bagla, 2014; Carneval, 2013; Grosso, 2015; Pisco, 2013; Rio Tinto, 2012; Wang, 2016; Antunes, 2013; Bilhim, 2013a; Bilhim, 2013b). Few post-PAE complications were reported in these studies, including urinary tract infection requiring antibiotics and acute post-PAE urinary retention requiring temporary catheterization.

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) position statement for use of prostate artery embolization for the treatment of benign disease of the prostate states (McWilliams, 2014):

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.

2020 Update

Prostatic Urethral Life (PUL)

Tanneru et al published a systematic review and meta-analysis of studies with at least 24 months of follow-up (Tanneru, 2020). Five studies were included: 3 noncomparative and 2 RCTs (LIFT and BPH6) (Chin, 2012; Rukstalis, 2016; Sievert, 2020).

Perera et al, Shore, Jones et al, and Tanneru analyzed data from the PUL arms of the studies only and the National Institute for Health and Care Excellence review was published before the BPH6 RCT (Perera, 2015; Shore, 2015; Jones, 2016; Tanneru, 2020). Therefore, these systematic reviews will not be discussed further.

Jung et al published a Cochrane systematic review of PUL parallel-group RCTs published up to Jan 2019 (Jung, 2019). The 2 included RCTs (n=297) were the LIFT and BPH6 trials described in detail in the following section (Roehrborn, 2013; Gratzke, 2017). The two RCTs included different comparators and results were not combined meta-analytically. The authors used the GRADE approach to rate the certainty of the evidence. The conclusions were as follows:

PUL appears less effective than TURP in improving urological symptoms, both in the short-term and long-term (low-certainty evidence);
PUL may result in a similar quality of life compared to TURP (low-certainty evidence);
PUL may result in similar erectile function compared to TURP (moderate-certainty evidence);
PUL may result in better ejaculatory function compared to TURP (moderate-certainty evidence);
Rates of major adverse events are unclear (very low-certainty evidence);
Rates of retreatment are unclear (very low-certainty evidence).

Surgical Reinterventions

Miller et al reported results of a systematic review and meta-analysis on surgical reintervention rate of PUL (Miller, 2020). Randomized or nonrandomized controlled studies, prospective and retrospective observational studies published through January 2020 were eligible for inclusion. Eleven studies (9 observational, 2 RCTs) were included with a total of 2,016 patients. The two RCTs (LIFT, BPH6) are described in the following section. There were 153 surgical reinterventions performed (TURP, 51.0%; repeat PUL, 32.7%, device explant, 19.6%). Overall, the annual rate of surgical reintervention was 6.0% per year (95% CI, 3.0% to 8.9%): 4.3% per year in studies with ≤1 year mean follow-up, 10.7% per year in studies with >1 year to 3 years mean follow-up, and 5.8% per year in one study with >3 years mean follow-up. No information was provided on the success of the reinterventions.

Sievert et al reported results of a noncomparative study that included 5 men with prostate volume greater than 80 mL (Sievert, 2019). Results were not presented stratified by prostate volume.

Shah et al reported a retrospective review of 74 patients at a single institution that had undergone PUL between 2014 and 2015 (Shah, 2018). Twenty-three of the patients had prostates larger than 80 g (median: 112 g, range: 81–254 g); 5 of the men with larger prostates had obstructive median lobe. Overall, median follow-up time between the date of PUL procedure and the last reported symptom rating during follow-up was 144 days; follow-up was not reported separately for the men with larger prostate volume follow-up. In the men with larger prostate volume, the median pre-operative AUA symptom score was 12. Twenty of the 23 men had post-operative AUA symptom score with a median of score of 3 (median improvement = 9, p<0.001). Three (13%) of men with larger prostate volume had repeat outlet procedure.

Eure included 38 men with prostate volume >80 mL (Eure, 2019). Although the authors reported that 'no significant differences in symptom response emerged based on prostate volume, results were not presented stratified by prostate volume.

Bozkurt, Woo and Chin included men with prostate volume greater than 80 mL but had mean volume in the 40 to 60 range and it is unclear how many patients had volume greater than 80 (Bozkurt, 2016; Woo, 2012; Chin, 2012). Given the limited amount of published data on outcomes for men with prostate volume greater than 80 mL and limited follow-up, the risks and benefits cannot be evaluated.

American Urological Association

In 2018, the American Urological Association published guidelines on the surgical management of LUTS attributed to BPH; the 2018 guidelines were amended in 2019 and 2020. The guidelines made the following recommendations and statements regarding prostatic urethral lift (PUL) (Foster, 2018).

"PUL [prostatic urethral lift] may be offered as an option for patients with LUTS [lower urinary tract symptoms] attributed to BPH [benign prostatic hyperplasia] provided prostate volume <80g and verified absence of an obstructive middle lobe."

"Moderate Recommendation; Evidence Level: Grade C indicating "Benefits > Risks/Burdens (or vice versa); Net benefit (or net harm) appears moderate. Applies to most patients in most circumstances but better evidence is likely to change confidence"

"PUL may be offered to eligible patients concerned with erectile and ejaculatory function for the treatment of with LUTS attributed to BPH."

"Conditional Recommendation; Evidence Level: Grade C indicating" Risks/Burdens unclear; Alternative strategies may be equally reasonable. Better evidence likely to change confidence"
"Clinicians should inform patients of the possibility of treatment failure and the need for additional or secondary treatments when considering surgical and minimally-invasive treatments for LUTS secondary to BPH."

2020 Update

Annual policy review completed with a literature search using the MEDLINE database through August 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

Transurethral Convective Water Vapor Thermal Ablation

Kang et al conducted a Cochrane review of transurethral water vapor thermal therapy for management of LUTS in men with BPH (Kang, 2020). In literature searches conducted through February 2020, the reviewers identified only one RCT, conducted by McVary et al. The reviewers concluded that there was moderate-to low-certainty evidence that the procedure appears to improve urologic symptom scores and quality of life compared to a sham procedure. However, there was very low certainty of evidence about the effects of the intervention on major adverse events.

Prostatic Urethral Lift (PUL)

AUA recommends surgical intervention for patients who have "renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with LUTS attributed to BPH refractory to and/or unwilling to use other therapies (Foster, 2020)."

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2021. The key identified literature is summarized below.

Aquablation for treatment of BPH has been assessed in 1 RCT, known as WATER (Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue)(Gilling, 2018). WATER was a noninferiority trial comparing aquablation with TURP in 181 participants at 17 sites in 4 countries. Participants were men ages 45 to 80 years with moderate-to-severe LUTS, defined as IPSS 10 score greater than or equal to 12, and prostate size between 30 and 80 cc. The primary efficacy endpoint was the difference between groups in the change in IPSS at 6 months, and the primary safety endpoint was the development of Clavien-Dindo persistent grade 1 or 2 or higher operative complications at 3 months. Primary endpoint results were reported by Gilling et al in 2018, 12 month results in Gilling et al in 2019, and 3 year results in Gilling et al in 2020 ( Gilling, 2018; Gilling, 2019;, Gilling, 2020). Additionally, a synthesis of the trial results up to 12 months was reported in a Cochrane systematic review conducted bye Hwang et al (Hwang, 2019).

On the primary efficacy outcome, aquablation was noninferiror to TURP. At 6 months, mean IPSS decreased from baseline by 16.9 points for aquablation and 15.1 points for TURP (mean difference 1.8 points; p< .0001 for noninferiority and p=.1347 for superiority). The primary safety endpoint rate was lower in the aquablation group compared to the TURP group (26% vs 42%, p=.0149). The rate of grade 2 and greater events was similar in the 2 groups (20% for aquablation and 23% for TURP; p=.3038).

Reviewers of the WATER trial results at 12 months, assessed the certainty of the evidence for each outcome using the GRADE approach (Hwang, 2019). The reviewers concluded that up to 12 months, aquablation likely results in a similar improvement in urologic symptom scores to TURP and may result in similar quality of life when compared to TURP. They also concluded that aquablation may result in little to no difference in major adverse events, but considered the evidence for this finding very low certainty due to study limitations and imprecision of estimates.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

The American Urological Association (AUA) recommends surgical intervention for patients who have "renal insufficiency secondary to BPH, refractory urinary retention secondary to BPH, recurrent urinary tract infections (UTIs), recurrent bladder stones or gross hematuria due to BPH, and/or with lower urinary tract symptoms (LUTS) attributed to BPH refractory to and/or unwilling to use other therapies". (Lerner, 2021).

In 2022, Franco et al published a Cochrane network meta-analysis assessing the comparative effectiveness of minimally invasive treatments for lower urinary tract symptoms in men with BPH (Franco, 2022). Twenty-seven trials representing 3017 men were included through February 2021. Compared to TURP, PUL and prostatic arterial embolization (PAE) were found to result in little to no difference in urological symptoms, while convective water vapor thermal therapy (eg, Rezum), transurethral microwave thermotherapy (TUMT), and temporary implantable nitinol devices (TIND) may result in worse urological outcomes. While minimally invasive treatments were found to result in little to no difference in quality of life compared to TURP, they were found to result in a large reduction in major adverse events. The overall certainty of the evidence according to GRADE criteria was low to very low across these outcomes. The authors were uncertain of the effects of PUL on erectile function (mean difference of International Index of Erectile Function, 3.00; 95% CI, -5.45 to 11.44), ejaculatory dysfunction (RR 0.05; 95% CI, 0.00 to 1.06), and retreatment rates (RR 2.39; 95% confidence interval [CI], 0.5 to 11.1) compared to TURP. Retreatment was defined as the number of participants requiring a follow-up procedure for lower urinary tract symptoms with another minimally invasive treatment or TURP, excluding follow-up procedures to treat complications, which were evaluated as major adverse events.

Gaffney et al performed a retrospective healthcare system database analysis of inpatient and ambulatory endoscopic procedures for BPH, identifying 175,150 men treated between 2000 and 2018 (Gaffney, 2021). More than half were treated with TURP, compared to 27% with prostate photovaporization and 10% with PUL. Readmission rates at 30 days were 2.2% for TURP, 2.1% for prostate photovaporization, and 1.2% for PUL (odds ratio [OR], 0.58; p <.01). Ninety-day readmission rates were 5.7% for TURP, 6.0% for prostate photovaporization, and 2.9% for PUL (OR, 0.55; p<.01). However, patients treated with PUL were almost twice as likely to be retreated at 2-year follow-up compared to those receiving TURP (OR, 1.78; p<.01). Retreatment rates at 2-years were 5.2% for PUL, 3.2% for prostate photovaporization, and 2.9% for TURP.

In a randomized control trial or Rezum, the primary outcome was the difference in the change from baseline between the treatment and control arms at 3 months post-treatment. The secondary outcome was the percentage of responders at 3 months. Response was defined as a 30% or greater improvement (reduction) in the IPSS at 3 months compared to baseline. The Rezum group showed an 11.2-point decrease in IPSS, versus a 4.3-point decrease in the sham group (p<0.001). There were more responders (defined as 30% or more improvement in the IPSS) in the Rezum group. Notably, more than half of the patients in the control group were classified as responders at 3 months. There were significant differences in other measures of LUTS and quality of life.

130 of the 197 participants (70.0%) reported being sexually active at baseline and were assessed for erectile function. There were no significant changes in erectile or ejaculatory function at follow-up and no differences between groups. That is, the treatment was not associated with adverse effects on erectile or ejaculatory function. A post hoc subgroup analysis of 125 Rezum-treated subjects who were sexually active at baseline found that sexual function continued to be unimpacted at 5 years (McVary, 2021). However, only 67 of these participants (53.6%) had follow-up data at this timepoint.

Two patients in the Rezum group experienced 3 serious procedure-related adverse events: 1 patient had de novo extended urinary retention and another had nausea and vomiting due to alprazolam and was hospitalized overnight for observation.

In 2021, the American Urological Association published guidelines on the surgical evaluation and treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) and included the following recommendations related to the interventions included in this evidence review (Lerner, 2021):

Water vapor thermal therapy should be considered as a treatment option for patients with LUTS/BPH provided prostate volume is 30 to 80 cc. (Moderate Recommendation; Evidence Level: Grade C)
Water vapor thermal therapy may be offered as a treatment option to eligible patients who desire preservation of erectile and ejaculatory function. (Conditional Recommendation; Evidence Level: Grade C)
Robotic waterjet treatment may be offered as a treatment option to patients with LUTS/BPH provided prostate volume is 30 to 80 cc. (Conditional Recommendation; Evidence Level: Grade C)

CPT/HCPCS:

0421T	Transurethral waterjet ablation of prostate, including control of post operative bleeding, including ultrasound guidance, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included when performed)
0582T	Transurethral ablation of malignant prostate tissue by high energy water vapor thermotherapy, including intraoperative imaging and needle guidance
36245	Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower extremity artery branch, within a vascular family
36246	Selective catheter placement, arterial system; initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family
36247	Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family
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
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 (List separately in addition to code for primary procedure)
53854	Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy
55899	Unlisted procedure, male genital system
75894	Transcatheter therapy, embolization, any method, radiological supervision and interpretation
C9739	Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants
C9740	Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants

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