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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Surgery
Policy Number:146
Effective Date: 09/08/2020
Original Policy Date:02/24/2015
Last Review Date:09/08/2020
Date Published to Web: 04/21/2015
Subject:
Prostatic Urethral Lift

Description:
_______________________________________________________________________________________

IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

__________________________________________________________________________________________________________________________

Benign prostatic hyperplasia (BPH) is a common condition in older individuals that can lead to increased urinary frequency, an urgency to urinate, a hesitancy to urinate, nocturia, and a weak stream when urinating. The prostatic urethral lift (PUL) procedure involves the insertion of one or more permanent implants into the prostate, which retracts prostatic tissue and maintains an expanded urethral lumen.

PopulationsInterventionsComparatorsOutcomes
Individuals:
    • With lower urinary tract obstruction symptoms due to benign prostatic hyperplasia who do not have sufficient response to medical therapy or are experiencing significant side effects with medical therapy
Interventions of interest are:
    • Prostatic urethral lift
Comparators of interest are:
    • Transurethral resection of the prostate
    • Minimally invasive prostate resection or ablation
    • Continued medical management
Relevant outcomes include:
    • Symptoms
    • Functional outcomes
    • Health status measures
    • Quality of life
    • Treatment-related morbidity

BACKGROUND

Benign Prostatic Hyperplasia

BPH is a common disorder among older individuals that results from hyperplastic nodules in the periurethral or transitional zone of the prostate. The clinical manifestations of BPH include increased urinary frequency, nocturia, urgency or hesitancy to urinate, and a weak stream when urinating. 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) and the International Prostate Symptom Score (IPSS). The AUASI is a self-administered 7-item questionnaire assessing the severity of various urinary symptoms.1, Total AUASI scores range from 0 to 35, with overall severity categorized as mild (≤7), moderate (8-19), or severe (20-35).2, The IPSS incorporates questions from the AUASI and a quality of life question or a "Bother score."3,

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 2013, the NeoTract UroLift® System UL400 (NeoTract) was cleared (after receiving clearance through the FDA's de novo classification process in March 2013; K130651/DEN130023). In 2016, the FDA determined that the UL500 was substantially equivalent to existing devices (UL400) for the treatment of symptoms of urinary flow obstruction secondary to BPH in individuals ages 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.

Related Policies

  • None

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

I. Use of prostatic urethral lift in individuals with moderate-to-severe lower urinary tract obstruction due to benign prostatic hyperplasia is considered medically necessary when all of the following criteria are met:


    · Member has persistent or progressive lower urinary tract symptoms despite medical therapy (a1-adrenergic antagonists maximally titrated, 5a-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months, or is unable to tolerate medical therapy; AND,
    · Prostate gland volume is ≤80 mL; AND,
    · Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND,
    · Member does not have urinary retention, urinary tract infection, or recent prostatitis (within past year); AND,
    · Member has had appropriate testing to exclude diagnosis of prostate cancer; AND,
    · Member does not have a known allergy to nickel, titanium or stainless steel.

II. Use of prostatic urethral lift in other situations, including repeat procedures, is considered investigational.


Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.


Medicaid Coverage:

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.




[RATIONALE: This policy was created in 2015 and has been updated regularly with a search of the PubMed database. The most recent literature update was performed through July 2, 2020.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the 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 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 a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and 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.

Prostatic Urethral Lift

Clinical Context and Therapy Purpose

The purpose of PUL in patients who have lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) is to provide a treatment option that is an alternative to or an improvement on existing therapies such as medical management or transurethral resection of the prostate (TURP).

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

For patients with moderate-to-severe symptoms (eg, an AUASI score of ≥8), bothersome symptoms, or both, a discussion about medical therapy is reasonable. BPH should generally be treated medically first. 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).2, In a meta-analysis of both indirect comparisons from placebo-controlled studies (including 6,333 patients) and direct comparative studies (including 507 patients), Djavan et al (1999) found that the IPSS improved by 30% to 40% and the Qmax score (mean peak urinary flow rate) improved by 16% to 25% in individuals assigned to α-adrenergic blockers.4, Combination therapy using an α-adrenergic blocker and 5α-reductase inhibitor has been shown to be more effective for improving IPSS than either treatment alone, with median scores improving by more than 40% over 1 year and by more than 45% over 4 years.

Patients who do not have sufficient response to medical therapy, or who are experiencing significant side effects with medical therapy, may be referred for surgical or ablative therapies. Various surgical and ablative procedures are used to treat BPH. Transurethral resection of the prostate is generally considered the reference standard for comparisons of BPH procedures.5, In the perioperative period, transurethral resection of the prostateis associated with risks of any operative procedure (eg, anesthesia risks, blood loss). Although short-term mortality risks are generally low, a large prospective study with 10654 patients by Reich et al (2008) 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%)."6, Incidental carcinoma of the prostate was diagnosed by histologic examination in 9.8% of patients. In the longer term, transurethral resection of the prostateis associated with increased risk of sexual dysfunction and incontinence.

Several minimally invasive prostate ablation procedures are available, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate. The minimally invasive procedures were individually compared with transurethral resection of the prostate at the time they were developed, which provided a general benchmark for evaluating those procedures.

The question addressed in this policy is: Does PUL improve the net health outcome in individuals with BPH?

The following PICO was used to select literature to inform this review.

Patients

BPH prevalence increases with age and is present in more than 80% of individuals ages 70 to 79.2,

The relevant population of interest are men who are experiencing lower urinary tract symptoms without a history suggesting non-BPH causes of the symptoms and who do not have sufficient response to medical therapy or are experiencing significant side effects with medical therapy.

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." 7,

Interventions

The therapy being considered is PUL. The PUL procedure involves the placement of one or more implants in 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, has been cleared for marketing by the U.S. Food and Drug Administration (see Regulatory Status section). The device has 2 main components: the delivery device and the implant. Each delivery device comes preloaded with a UroLift implant.

Comparators

Various surgical or ablative procedures are used to treat BPH. TURP is generally considered the reference standard for comparisons of BPH procedures. 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.

Outcomes

A number of health status measures are used to evaluate symptoms relevant to BPH and adverse events of treatment for BPH, including urinary symptoms, urinary dysfunction measured by urinary flow rate (Qmax), ejaculatory dysfunction, overall sexual health, and overall quality of life. Qmax is measured by uroflowmetry; low rates associated with more voiding dysfunction and rates <10 mL/sec are considered obstructed.

Outcomes data demonstrating durability to at least 2 years is preferred.

Some validated patient-reported scales are shown in Table 1.

Of note, the prostate volume does not have a direct correlation with the severity of urinary symptoms.8,

Table 1. Patient-Reported Health Outcome Measures Relevant to Benign Prostatic Hyperplasia
MeasureOutcome EvaluatedDescriptionClinically Meaningful Difference (If Known)
Male Sexual Health Questionnaire for Ejaculatory Dysfunction9,Ejaculatory function and quality of lifePatient-administered, 4-item scale.Symptoms rated as absent (15) to severe (0). QOL assessed as no problem (0) to extremely bothered (5).NR
Sexual Health Inventory for Men10,Erectile functionPatient-administered, 5-item scale. Erectile dysfunction rated as severe (1-7), moderate (8-11), mild to moderate (12-16), or mild (17-21). Fewest symptoms present for patients with scores 22-25.5-point change11,
American Urological Association Symptom Index; International Prostate Symptom Score 2,3,12,Severity of lower urinary tract symptomsPatient-administered, 7-item scale. Symptoms rated as mild (0-7), moderate (8-19), or severe (20-35)

IPSS asks an additional question, rating QOL as delighted (0) to terrible (6)

  • Minimum of 3-point change 12,2,
  • Minimum of 30% change13,
Benign Prostatic Hyperplasia Impact Index14,1,Effect of urinary symptoms on health domainsPatient-administered, 4-item scale. Symptoms rated as absent (0) to severe (13).Minimum of 0.4-point change12,
IPSS: International Prostate Symptom Score; QOL: quality of life; NR: Not reported

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

    • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
    • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
    • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
    • Studies with duplicative or overlapping populations were excluded.
Review of Evidence

Systematic Reviews

Initial Prostatic Urethral Lift procedure

Several systematic reviews on PUL have been published. They include a similar set of trials and noncomparative studies. The overlap of studies is shown in Appendix Table 3. Perera et al (2015) reported on the results of a systematic review and meta-analysis15, of studies reporting outcomes after the PUL procedure, which included 7 prospective cohort studies,16,17,18,19,20,21,22, a crossover study (Cantwell et al [2014]16,), and the LIFT RCT (Roehrborn et al [2013],23,)

McVary et al [2014]24,). Shore (2015)25, performed a systematic review of UroLift studies, which included the LIFT RCT (Roehrborn et al [2013]23,; Roehrborn et al [2015]26,; McVary et al [2014]24,), a crossover study (Cantwell et al [2014]16,), and 4 prospective cohort studies (Garrido Abad et al [2013]27,; Chin et al [2012]19,; Woo et al [2012]20,; McNicholas et al [2013]18,).

Jones et al (2016) performed a systematic review of UroLift studies with at least 12 months of follow-up.28, Seven studies were identified, which included 4 noncomparative studies (Woo et al [2011],21, Chin et al [2012],19, McNicholas et al [2013],18, Bozkurt et al [2016]29,), a crossover study (Cantwell et al [2014]16,), and 2 RCTs (LIFT23, and BPH11,).

The National Institute for Health and Care Excellence (2016) published technical guidance on prostatic lift procedures.30,The National Institute for Care Excellence 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),15, except for the exclusion of Hoffman et al (2012)22, in the analysis.

Tanneru et al (2020) published a systematic review and meta-analysis of studies with at least 24 months of follow-up.31, Five studies were included; 3 noncomparative studies (Chin et al [2012]19,, Rukstalis (2016)32,, Sievert et al [2020]33, and 2 RCTs (LIFT and BPH6).

Perera et al (2015), Shore (2015), Jones et al (2016) and Tanneru (2020) 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. Therefore, these sytematic reviews s will not be discussed further.

Jung et al (2019) published a Cochrane systematic review of PUL parallel-group RCTs published up to Jan 2019.34,. The 2 included RCTs (n=297) were the LIFT and BPH6 trials described in detail in the following section.23,35, The 2 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 (2020) reported results of a systematic review and meta-analysis on surgical reintervention rate of PUL.36, 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 2 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.

Randomized Controlled Trials

Two RCTs of PUL have been performed. Key trial characteristics and study results are shown below in Tables 2 and 3, 6 and 7. Additionally, a brief description of each trial is provided in the following sections.

Table 2. PUL Randomized Controlled Trial Characteristics
Study; TrialCountriesSitesDatesInclusion Criteria
Interventions, n
Baseline Prostate Volume, cm3
Active
Comparator
Sonksen et al (2015)11,; BPH6Denmark, Germany, U.K.10Feb 2012-
Oct 2013
Age ≥50 y, IPSS >12, prostate volume ≤60 cm3, without median lobe obstruction
16-59
PUL=46
TURP=45
Roehrborn et al (2013)23,; LIFTU.S., Canada, Australia19Feb-Dec 2011Age ≥50 y, IPSS ≥13, prostate volume 30-80 cm3, washed out of BPH medications, without median lobe obstruction
30-77
PUL=140
Sham=66
BPH: benign prostatic hypertrophy; IPSS: International Prostate Symptom Score; PUL: prostatic urethral lift; TURP: transurethral resection of the prostate.

BPH6 Study

Sonksen et al (2015) reported on the 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.11, 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 a median lobe obstruction in the prostate or signs of active infection. The trial used a novel composite endpoint, 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 endpoint has not been previously validated, core components of the composite score have been independently validated in a clinical setting. The trial used a noninferiority design with a margin of 10% for the primary endpoint, BPH6. Study investigators modified 2 of the original endpoint 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 a visual analog scale from 80 to 70.

Table 3. Summary of Evidence From the BPH6 Study
Outcomes
3 Months
12 Months
24 Months
PUL
TURP
PUL
TURP
PUL
TURP
Mean change in IPSS
n
42
34
40
32
37
32
Mean (SD)
-11.7 (8.5)
-11.8 (9.5)
-10.9 (7.9)
-15.4 (6.8)
-9.2 (9.2)
-15.3 (7.5)
p
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
Comparison (p)
0.978
0.013
0.004
Change in IPSS QOL
n
43
34
40
32
37
32
Mean (SD)
-2.6 (1.7)
-2.4 (2.0)
-2.8 (1.8)
-3.1 (1.6)
-2.5 (1.8)
-3.3 (1.6)
p
<0.001
<0.001
<0.001
<0.001
<0.001
<0.001
Comparison (p)
0.55
0.436
0.066
Change in Qmax
n
33
25
32
29
27
27
Mean (SD)
4.2 (5.0)
12.7 (9.8)
4.0 (4.8)
13.7 (10.4)
5.0 (5.5)
15.8 (16.5)
p
<0.001
0.003
<0.001
0.003
<0.001
0.002
Comparison (p)
<0.001
<0.001
0.002
Change in SHIM score
n
38
27
32
27
29
28
Mean (SD)
-0.7 (5.2)
-1.0 (5.2)
-0.1 (4.7)
-0.9 (4.3)
-0.2 (4.3)
-1.8 (4.90)
p
0.386
0.328
0.940
0.29
0.832
0.067
Comparison (p)
0.861
0.486
0.201
Change in MSHQ-EjD function score
n
38
27
32
27
29
27
Mean (SD)
-0.7 (2.1)
-3.0 (4.1)
1.3 (3.3)
-3.7 (4.1)
0.3 (3.4)
-4.0 (4.6)
p
0.251
<0.001
<0.001
0.666
<0.001
Comparison (p)
<0.001
<0.001
<0.001
Change in MSHQ-EjD bother score
n
38
28
32
27
29
27
Mean (SD)
-0.7 (2.1)
0.2 (1.5)
0.5 (2.2)
0.0 (1.5)
-0.1 (2.2)
-0.3 (1.9)
p
0.062
0.470
0.214
0.896
0.734
0.415
Comparison (p)
0.069
0.359
0.771
Composite score
NR
NR
Response: 52%
Response: 20%
NR
NR
Comparison (95% CI); p
NR
Difference: 32%(10% to 51%); 0.005
NR
Clavien-Dindo adverse events
Grade 1, n (%)
NR
NR
30 (68)
26 (74)
NR
NR
Adverse events
60
79
Grade 2, n (%)
NR
NR
3 (7)
4 (11)
NR
NR
Adverse events
3
5
Grade 3, n (%)
NR
NR
4 (9)
5 (14)
NR
NR
Adverse events
4
5
Adapted from Gratzke et al (2017).35,
BPH: benign prostatic hypertrophy; CI: confidence interval; IPSS: International Prostate Symptom Score; MSHQ-EjD: Male Sexual Health Questionnaire for Ejaculatory Dysfunction; NR: not reported; PUL: prostatic urethral lift; Qmax: mean peak urinary flow rate; QOL: quality of life; SD: standard deviation; SHIM: Sexual Health Inventory for Men; TURP: transurethral resection of the prostate.

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 violating 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 endpoint 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 endpoint 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 endpoint 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 BPH6.35, 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. 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, as described in Table 3. 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.

The purpose of the limitations tables (see Tables 4 and 5) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of the evidence supporting the position statement.

Table 4. Study Relevance Limitations
StudyPopulationaInterventionbComparatorcOutcomesdFollow-Upe
BPH63. Unclear history of BPH treatments4: Primary outcome was not validated
LIFT3. Unclear history of BPH treatments2: Men were washed out of medication
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
BPH: benign prostatic hypertrophy.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.


Table 5. Study Design and Conduct Limitations
StudyAllocationaBlindingbSelective ReportingcData CompletenessdPowereStatisticalf
BPH61. Blinding not feasible6. Only per-protocol analysis presented
LIFT1, 2, 5. High losses and/or exclusions in extended follow-up, only LOCF sensitivity analyses provided3, 4. CI not reported for treatment effects
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
CI: confidence interval; LOCF: last observation carried forward.

a
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c
Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d
Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e
Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f
Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4.Comparative treatment effects not calculated.
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 endpoint. This endpoint 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

Comparative Data

Roehrborn et al (2013) reported on results of the pivotal LIFT study, an RCT comparing PUL with sham control among 206 individuals ages 50 and older with lower urinary tract symptoms secondary to BPH.23, Eligible patients had an American Urological Association Symptom Index (AUASI) score 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 medications before enrollment; the washout period was 2 weeks for α-blockers and 3 months for 5α-reductase inhibitors. Patients were randomized to PUL (n=140) or sham control (n=66) and evaluated at 3 months postprocedure for the trial's primary efficacy endpoint. After that, all patients were unblinded, and sham control patients were permitted to undergo the PUL procedure. Fifty-three control subjects eventually underwent a PUL procedure. The analysis was intention-to-treat. The study met its primary efficacy endpoint, which was that the reduction in AUASI score at 3 months postprocedure had to be at least 25% greater after the PUL than the reduction in AUASI score 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 PUL patients (see Table 6). The 3-month change in Qmax was 4.28 mL/s for PUL patients and 1.98 mL/s for sham control patients (p=0.005). Compared with sham control patients, PUL patients had greater improvements in quality of life scores and BPH-II score (see Table 7). Nine serious adverse events in 7 patients were reported in the PUL group, and 1 serious adverse event was reported in the sham group during the first 3 months of follow-up. Limitations in the trial design are summarized in Tables 4 and 5.

McVary et al (2014) reported on sexual function outcomes in a subset of patients from the LIFT study.24,At baseline, 53 (38%) PUL 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, MSHQ-EjD function scale and the MSHQ-EjD bother scale did not differ significantly between groups.

Table 6. Summary of LIFT Initial Trial Results
Study
Change in IPSS
Change in IPSS QOL
Change in Qmax
Change in MSHQ-EjD Function
Change in MSHQ-EjD Bother
Any Adverse Events, n (%)
Serious Adverse Events, n (%)
LIFT
N at 3 months
206
206
182
144
177
206
206
PUL
-11.1 (7.7)
-2.2 (1.8)
4.3 (5.2)
2.2 (2.5)
-0.8 (1.5)
122 (87%)
7 (5%)
Adverse events
268
9
Sham
-5.9 (7.7)
-1.0 (1.5)
2.0 (4.9)
1.7 (2.6)
-0.7 (1.6)
43 (52%)
1 (1.5%)
Adverse events
53
1
TE (p)
NR
(0.003)
NR (<0.001)
NR (0.005)
NR
(0.283)
NR
(0.60)
NR
NR
Adapted from Roehrborn et al (2013).23,
Values are mean (standard deviation) unless otherwise indicated.
IPSS: International Prostate Symptom Score; MSHQ-EjD: Male Sexual Health Questionnaire for Ejaculatory Dysfunction; NR: not reported; PUL: prostatic urethral lift; Qmax: mean peak urinary flow rate; QOL: quality of life; TE: treatment effect.


Table 7. Summary of Evidence for LIFT Study, Including Participants in the PUL Group
Outcomes
3 Months
1 Year
2 Years
3 Years
5 Years
N
140
129
118
109
87
Death/LTFU
0
2
7
2
18
Protocol deviations
3
0
0
1
0
Retreatment
0
6
4
6
4
Change in IPSS
n
136
123
103
93
72
Change
-11.14 (7.72)
-10.61 (7.51)
-9.13 (7.62)
-8.83 (7.41)
-35.9%
95% CI
-12.45 to -9.83
-11.95 to -9.27
-10.62 to -7.64
-10.35 to -7.30
-44.4% to -27.3%
p
<0.001
<0.001
<0.001
<0.001
<0.001
Change in IPSS QOL
n
136
123
103
93
72
Change
-2.22 (1.78)
-2.31 (1.60)
2.19 (1.72)
-2.25 (1.72)
-50.3
95% CI
-2.52 to -1.92
-2.59 to -2.02
-2.53 to -1.86
-2.60 to -1.89
-58.4% to -42.2%
p
<0.001
<0.001
<0.001
<0.001
<0.001
Change in Qmax
n
122
102
86
69
52
Change
4.29 (5.16)
4.03 (4.96)
4.21 (5.09)
3.47 (5.00)
44.3%
95% CI
3.36 to 5.21
3.06 to 5.00
3.12 to 5.30
2.27 to 4.67
29.4% to 59.1%)
p
<0.001
<0.001
<0.001
<0.001
<0.001
Change in SHIM score
n
91
87
72
66
NR
Change
1.27 (4.65)
0.70 (5.12)
1.06 (4.78)
0.53 (4.41)
NR
95% CI
0.31 to 2.24
-0.39 to 1.79
-0.07 to 2.18
-0.55 to 1.62
NR
p
0.005
0.299
0.046
0.338
NR
Change in MSHQ-EjD function score
n
91
87
72
66
49
Change
2.31 (2.58)
1.56 (2.68)
1.08 (2.51)
0.56 (2.48)
9.3%
95% CI
1.77 to 2.85
0.99 to 2.13
0.49 to 1.67
-0.05 to 1.17
-3.8% to 22.5%
p
<0.001
<0.001
<0.001
0.013
0.096
Change in MSHQ-EjD bother score
n
91
87
72
66
49
Change
-1.07 (1.44)
-0.76 (-1.55)
0.63 (1.51)
-0.59 (1.52)
-6.3%
95% CI
-1.37 to -0.77
-1.09 to -0.43
-0.98 to -0.27
-0.96 to -0.22
-31.5% to 18.8%
p
<0.001
<0.001
<0.001
<0.001
0.019
Adapted from Roehrborn et al (2015)37, for data from 3 months to 3 years and Roehrborn et al (2017)38, for data for 5 years.
While not specifically indicated, change values likely represent means and standard deviations.
CI: 95% confidence interval; IPSS: International Prostate Symptom Score; LTFU: lost to follow-up; MSHQ-EjD: Male Sexual Health Questionnaire for Ejaculatory Dysfunction; NR: not reported; PUL: prostatic urethral lift; Qmax: mean peak urinary flow rate; QOL: quality of life; SHIM: Sexual Health Inventory for Men.


Follow-Up of Sham-Assigned Crossover Participants

Cantwell et al (2014) reported on 12-month outcomes for 53 subjects in the LIFT sham control group who underwent PUL after unblinding at 3 months postprocedure.16, Crossover (unblinded) patients had a change in IPSS from 23.4 to 12.3 at 3 months postprocedure compared with the change in IPSS 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 (-3.3) than in the sham period (-1.9; p=0.024) but did not report significant differences in improvement in Qmax. Change in sexual function scores did not differ significantly after the sham procedure compared with after theactive 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.32, 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, not reported; 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).

Follow-Up of PUL-Assigned Participants

Roehrborn et al (2015) reported on 3-year results from patients randomized to PUL in the LIFT study.26,After exclusion of 11 subjects who were lost to follow-up, 36 subjects with 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 PUL procedures, 9 with TURP or laser vaporization), the 3-year effectiveness analysis included 93 (66%) of the original 140 subjects. For subjects with follow-up data, change in IPSS was -8.83 (95% CI, -10.35 to -7.30; p<0.001). Significant improvements were also reported for the quality of life score, BPH-II score, and Qmax. Sexual function was unchanged. Implants were removed from 10 participants. No analyses were performed to assess how sensitive the results were to changes in the assumptions about the considerable amount of missing data.

Roehrborn et al (2016) reported on 4-year results from patients randomized to PUL in the LIFT study.37, Of the 140 originally randomized patients, 32 were lost by the 4-year follow-up visit (6 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 the 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.38, 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 the 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 (approximately 50% of those randomized) 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, compared with baseline, continued to be reported for scores associated with quality of life, Qmax, and BPH-II. Of the limited number of patients that remained in the analysis, 13.6% had surgical reintervention by 5 years.

Subsection Summary: LIFT Study

The LIFT RCT compared PUL with a sham procedure in individuals who had completed a washout period for 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 did so. Functional improvements, 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 the 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 ejaculatory 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 relative to patients receiving sham treatment and preserved sexual function. 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; a high number of patients were either excluded or lost to follow-up during this time. The BPH6 and LIFT RCTs excluded men with median lobe obstruction.

Noncomparative Studies

The approved indications for PUL have expanded since the original approval to include men with median lobe obstruction and those with prostate volume between 80cc and 100cc. Neither of these expansions have supporting RCTs.

Median lobe obstruction

Several noncomparative studies were published including men without median lobe obstruction. These studies were previously enumerated in the description of the systematic reviews and are shown in Appendix Table 3. Since RCTs with long-term follow-up exist for this population, these noncomparative studies will not be discussed in further detail.

Rukstalis et al (2019) reported results of the MedLift study, the study used to support the expansion of the U.S. Food and Drug Administration clearance for PUL to include obstructive median lobes.39, MedLift was a single-arm study enrolling 45 men with eligibility criteria identical to LIFT except requiring obstructive median lobes. Results in the MedLift cohort were compared to the LIFT historical cohort. Characteristics are shown in Table 8.and results are shown in Table 9. One patient required surgical retreatment and no implants were removed over the 12 months of follow-up.

Table 8. Summary of Characteristics of Key Non-comparative Studies
StudyCountrySitesParticipantsTreatment DeliveryFollow-Up
Rukstalis (2019)US9n=45

Men ages 50+ with IPSS>13, Qmax <=12 mL/s, 30 to 80 cc intraurethral prostatic volume and, OMLa

UroLift PUL procedure with median lobe deployment12 months
aOML (Obstructive Median Lobe) was defined as excessive posterior tissue that precludes a normal lateral lobe procedure.

Table 9. Summary Results of Key Non-comparative Studies
StudyIPSSIPSS QOLQmaxSHIM
Rukstalis (2019)At 12 mAt 12 mAt 12 mAt 12 m
n44443738
Change from baseline, mean (SD); p-value-13.5 (7.7); p<0.001-3.0 (1.5); p<0.0016.4 (7.4); p<0.0011.2 (4.3); p=0.04
CI: 95% confidence interval; IPSS: International Prostate Symptom Score; Qmax: mean peak urinary flow rate; QOL: quality of life; SHIM: Sexual Health Inventory for Men; SD: standard deviation.
The purpose of the limitation tables (see Tables 10 and 11) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of the evidence supporting the position statement.

Table 10. Study Relevance Limitations
StudyPopulationaInterventionbComparatorcOutcomesdFollow-Upe
Rukstalis (2018)3. Unclear history of BPH treatments2: No concurrent comparator3: Reporting of adverse events was qualitative; rates not reported1, 2: Only 12 m of follow-up reported
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
BPH: benign prostatic hypertrophy.

a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b
Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
c
Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
d
Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e
Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 11. Study Design and Conduct Limitations
StudyAllocationaBlindingbSelective ReportingcData CompletenessdPowereStatisticalf
Rukstalis (2018)1,2: Not randomized1,2: No blinding>15% missing data for Qmax and SHIM3: CIs not reported
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
CI: confidence interval; Qmax: mean peak urinary flow; SHIM: Sexual Health Inventory for Men.

a
Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b
Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c
Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
d
Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e
Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f
Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Prostate Volume Greater Than 80 mL

Sievert et al (2019) reported results of a noncomparative study that included 5 men with prostate volume greater than 80 mL.33, Results were not presented stratified by prostate volume.

Shah et al (2018) reported a retrospective review of 74 patients at a single institution that had undergone PUL between 2014 and 2015.40, 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 (2019)41, included 38 men with prostate volume >80 mL. 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 (2016)29,, Woo (2012)20, and Chin (2012)19, 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.

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.

Section Summary: Noncomparative Studies

One single-arm study (n=45) including men with obstructive median lobes has been conducted and was used to support the U.S. Food and Drug Administration expansion of the PUL indication to include these men. Symptom scores and quality of life appeared to improve by statistically and clinically significant amounts and were similar in magnitude to improvements reported in the original LIFT study. Rates of adverse events were not reported. Design and conduct limitations preclude interpretation.

Noncomparative studies have included a small number of men with larger prostate volume but have generally not reported results stratified by prostate volume. One study presented data for 20 men with less than 6 months of follow-up.

Summary of Evidence

For individuals who have lower urinary tract obstruction symptoms due to BPH who do not have sufficient response to medical therapy or are experiencing significant side effects with medical therapy and receive a PUL, the evidence includes systematic reviews, RCTs, and noncomparative studies. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related morbidity. One RCT, 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 endpoint, which required concurrent fulfillment 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 ejaculatory function. These findings were corroborated by another RCT (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 BPH6 and LIFT RCTs included men with prostate volume up to 80 cm3 and excluded men with median lobe obstruction. Selection criteria of patients for whom evidence is sufficient to support improvement are derived from clinical trial eligibility criteria, product labeling, and clinical input. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

SUPPLEMENTAL INFORMATION

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2017

In response to requests, while this policy was under review in 2017, clinical input on the use of a prostatic urethral lift for 3 indications were received from 4 respondents, including 2 physician-level responses identified through a specialty society and 2 physician-level responses identified through an academic medical center. Evidence from clinical input is integrated within the Rationale section summaries and the Summary of Evidence.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

In 2014, the National Institute for Health and Care Excellence published guidance on urethral lift implants to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).42, The guidance stated:

"Current evidence on the efficacy and safety of insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia is adequate to support the use of this procedure."

In 2015, the National Institute for Health and Care Excellence published guidance on the use of UroLift for treating LUTS of BPH.43, The guidance stated: "the UroLift system is effective in relieving symptoms of benign prostatic hyperplasia" and "the UroLift system should be considered as an alternative to current surgical procedures for use in a day-case setting in individuals with lower urinary tract symptoms of benign prostatic hyperplasia who are aged 50 years and older and who have a prostate of less than 100 ml without an obstructing middle lobe."

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 20207, The guidelines made the following recommendations and statements regarding prostatic urethral lift (PUL).

    • "PUL 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 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."

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in July 2020 did not identify any ongoing or unpublished trials that would likely influence this review.]
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Prostatic Urethral Lift
PUL
UroLift System
UroLift
NeoTract UroLift
Implantable Transprostatic Tissue Retractor System
Transprostatic Tissue Retractor System

References:
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2. Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. Jul 19 2012; 367(3): 248-57. PMID 22808960

3. O'leary MP. Validity of the bother score in the evaluation and treatment of symptomatic benign prostatic hyperplasia. Rev Urol. 2005; 7(1): 1-10. PMID 16985801

4. Djavan B, Marberger M. A meta-analysis on the efficacy and tolerability of alpha1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur Urol. 1999; 36(1): 1-13. PMID 10364649

5. Foster HE, Barry MJ, Dahm P, et al. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. J Urol. Sep 2018; 200(3): 612-619. PMID 29775639

6. Reich O, Gratzke C, Bachmann A, et al. Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients. J Urol. Jul 2008; 180(1): 246-9. PMID 18499179

7. Foster HE, Barry MJ, Dahm P, et al. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. 2020. http://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(bph)-guideline. Accessed August 31, 2020.

8. Sundaram D, Sankaran PK, Raghunath G, et al. Correlation of Prostate Gland Size and Uroflowmetry in Patients with Lower Urinary Tract Symptoms. J Clin Diagn Res. May 2017; 11(5): AC01-AC04. PMID 28658743

9. Rosen RC, Catania JA, Althof SE, et al. Development and validation of four-item version of Male Sexual Health Questionnaire to assess ejaculatory dysfunction. Urology. May 2007; 69(5): 805-9. PMID 17482908

10. Cappelleri JC, Rosen RC. The Sexual Health Inventory for Men (SHIM): a 5-year review of research and clinical experience. Int J Impot Res. Jul-Aug 2005; 17(4): 307-19. PMID 15875061

11. Sonksen J, Barber NJ, Speakman MJ, et al. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. Oct 2015; 68(4): 643-52. PMID 25937539

12. Barry MJ, Williford WO, Chang Y, et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients?. J Urol. Nov 1995; 154(5): 1770-4. PMID 7563343

13. Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial. J Urol. May 2012; 187(5): 1732-8. PMID 22425127

14. McVary KT, Roehrborn CG, Avins AL, et al. American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH). 2010 (affirmed 2014); http://www.auanet.org/guidelines/benign-prostatic- hyperplasia-(2010-reviewed-and-validity-confirmed-2014). Accessed July 2, 2020.

15. Perera M, Roberts MJ, Doi SA, et al. Prostatic urethral lift improves urinary symptoms and flow while preserving sexual function for men with benign prostatic hyperplasia: a systematic review and meta-analysis. Eur Urol. Apr 2015; 67(4): 704-13. PMID 25466940

16. Cantwell AL, Bogache WK, Richardson SF, et al. Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. BJU Int. Apr 2014; 113(4): 615-22. PMID 24765680

17. Shore N, Freedman S, Gange S, et al. Prospective multi-center study elucidating patient experience after prostatic urethral lift. Can J Urol. Feb 2014; 21(1): 7094-101. PMID 24529008

18. McNicholas TA, Woo HH, Chin PT, et al. Minimally invasive prostatic urethral lift: surgical technique and multinational experience. Eur Urol. Aug 2013; 64(2): 292-9. PMID 23357348

19. Chin PT, Bolton DM, Jack G, et al. Prostatic urethral lift: two-year results after treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Urology. Jan 2012; 79(1): 5-11. PMID 22202539

20. Woo HH, Bolton DM, Laborde E, et al. Preservation of sexual function with the prostatic urethral lift: a novel treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Sex Med. Feb 2012; 9(2): 568-75. PMID 22172161

21. Woo HH, Chin PT, McNicholas TA, et al. Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. Jul 2011; 108(1): 82-8. PMID 21554526

22. Hoffman RM, Monga M, Elliott SP, et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev. Sep 12 2012; (9): CD004135. PMID 22972068

23. Roehrborn CG, Gange SN, Shore ND, et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. J Urol. Dec 2013; 190(6): 2161-7. PMID 23764081

24. McVary KT, Gange SN, Shore ND, et al. Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift. J Sex Med. Jan 2014; 11(1): 279-87. PMID 24119101

25. Shore N. A Review of the Prostatic Urethral Lift for Lower Urinary Tract Symptoms: Symptom Relief, Flow Improvement, and Preservation of Sexual Function in Men With Benign Prostatic Hyperplasia. Curr Bladder Dysfunct Rep. NA 2015; 10(2): 186-192. PMID 25984251

26. Roehrborn CG, Rukstalis DB, Barkin J, et al. Three year results of the prostatic urethral L.I.F.T. study. Can J Urol. Jun 2015; 22(3): 7772-82. PMID 26068624

27. Garrido Abad P, Coloma Del Peso A, Sinues Ojas B, et al. [Urolift(R), a new minimally invasive treatment for patients with low urinary tract symptoms secondary to BPH. Preliminary results]. Arch Esp Urol. Jul-Aug 2013; 66(6): 584-91. PMID 23985459

28. Jones P, Rajkumar GN, Rai BP, et al. Medium-term Outcomes of Urolift (Minimum 12 Months Follow-up): Evidence From a Systematic Review. Urology. Nov 2016; 97: 20-24. PMID 27208817

29. Bozkurt A, Karabakan M, Keskin E, et al. Prostatic Urethral Lift: A New Minimally Invasive Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urol Int. 2016; 96(2): 202-6. PMID 26613256

30. Ray A, Morgan H, Wilkes A, et al. The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance. Appl Health Econ Health Policy. Oct 2016; 14(5): 515-26. PMID 26832146

31. Tanneru K, Gautam S, Norez D, et al. Meta-analysis and systematic review of intermediate-term follow-up of prostatic urethral lift for benign prostatic hyperplasia. Int Urol Nephrol. Jun 2020; 52(6): 999-1008. PMID 32065331

32. Rukstalis D, Rashid P, Bogache WK, et al. 24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham. BJU Int. Oct 2016; 118 Suppl 3: 14-22. PMID 27684483

33. Sievert KD, Schonthaler M, Berges R, et al. Minimally invasive prostatic urethral lift (PUL) efficacious in TURP candidates: a multicenter German evaluation after 2 years. World J Urol. Jul 2019; 37(7): 1353-1360. PMID 30283994

34. Jung JH, Reddy B, McCutcheon KA, et al. Prostatic urethral lift for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. Cochrane Database Syst Rev. May 25 2019; 5: CD012832. PMID 31128077

35. Gratzke C, Barber N, Speakman MJ, et al. Prostatic urethral lift vs transurethral resection of the prostate: 2-year results of the BPH6 prospective, multicentre, randomized study. BJU Int. May 2017; 119(5): 767-775. PMID 27862831

36. Miller LE, Chughtai B, Dornbier RA, et al. Surgical Reintervention Rate after Prostatic Urethral Lift: Systematic Review and Meta-Analysis Involving over 2,000 Patients. J Urol. May 12 2020: 101097JU0000000000001132. PMID 32396049

37. Roehrborn CG. Prostatic Urethral Lift: A Unique Minimally Invasive Surgical Treatment of Male Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urol Clin North Am. Aug 2016; 43(3): 357-69. PMID 27476128

38. Roehrborn CG, Barkin J, Gange SN, et al. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. Jun 2017; 24(3): 8802-8813. PMID 28646935

39. Rukstalis D, Grier D, Stroup SP, et al. Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study. Prostate Cancer Prostatic Dis. Sep 2019; 22(3): 411-419. PMID 30542055

40. Shah BB, Tayon K, Madiraju S, et al. Prostatic Urethral Lift: Does Size Matter?. J Endourol. Jul 2018; 32(7): 635-638. PMID 29631445

41. Eure G, Gange S, Walter P, et al. Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study. J Endourol. Jul 2019; 33(7): 576-584. PMID 31115257

42. National Institute for Health and Care Excellence (NICE). Insertion of prostatic urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia [IPG475]. 2014; https://www.nice.org.uk/guidance/ipg475/chapter/1-recommendations. Accessed July 2, 2020.

43. National Institute for Health and Care Excellence (NICE). UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia [MTG26]. 2015; https://www.nice.org.uk/guidance/mtg26. Accessed July 2, 2020.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

    52441
    52442
HCPCS
    C9739
    C9740

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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