Coverage Policy Manual
Policy #: 2015024
Category: Surgery
Initiated: August 2015
Last Review: May 2018
  Prostatic Urethral Lift (UroLift System)

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. BPH prevalence increases with age and is present in more than 80% of men aged 70 to 79 (Sarma, 2012). 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.
 
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 in Table 1.
 
Table 1. 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. FDA product code: PEW.
 
 
Coding
 
There are specific CPT codes for this 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)
 

Policy/
Coverage:
Effective May 2018
 
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 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 ≤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
 
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 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.
 
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.
 
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:
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.

CPT/HCPCS:
52441Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant
52442Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; each additional permanent adjustable transprostatic implant (List separately in addition to code for primary procedure)

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(AUA) AUA. American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH). 2010; https://www.auanet.org/common/pdf/education/clinical-guidance/Benign-Prostatic-Hyperplasia.pdf. Accessed July 22, 2015.

(NICE) NIfHaCE.(2014) Nice Interventional Procedural Guidance IPG475: Insertion of Prostatic Urethral Lift Implants to Treat Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. 2014; http://www.nice.org.uk/guidance/ipg475/chapter/1-recommendations. Accessed July 22, 2015.

American Urological Association (AUA).(2014) Guideline: Management of Benign Prostatic Hyperplasia. 2010, reafirrmed 2014; http://www.auanet.org/education/guidelines/benign-prostatic-hyperplasia.cfm. Accessed June 11, 2015.

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Garrido Abad P, Coloma Del Peso A, Sinues Ojas B, et al.(2013) 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):584-591. PMID 23985459

Garrido Abad P, Coloma Del Peso A, Sinues Ojas B, et al.(2013) 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):584-591. PMID 23985459

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