Medical Policies - Surgery


Prostatic Urethral Lift (PUL) for the treatment of Benign Prostatic Hyperplasia (BPH)

Number:SUR710.023

Effective Date:10-15-2017

Coverage:

The UroLift system may be considered medically necessary for treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) when ALL of the following criteria are met:

Age 50 years or older; AND

Prostate size no greater than 80 grams based on ultrasound imaging; AND

International Prostate System Score (IPSS) ≥ 13; AND

Peak flow rate (Qmax) ≤ 12mL/second; AND

No obstructive median lobe; AND

No active urinary tract infection; AND

Conservative management options have been unsuccessful; AND

Surgical intervention is indicated.

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. (1) 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. (2) Total AUASI scores range from 0 to 35, with overall severity categorized as mild (≤7), moderate (8-19), or severe (20-35). The International Prostate Symptom Score incorporates the questions from the AUASI and a quality of life question or “Bother score.” (3)

Management of BPH

Evaluation and management of BPH includes evaluation for other causes of lower urinary tract dysfunction (e.g., 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 (e.g., AUASI score, ≥8), bothersome symptoms, or both. Available medical therapies for BPH-related lower urinary tract dysfunction include α-adrenergic blockers (e.g., alfuzosin, doxazosin, tamsulosin, terazosin, silodosin), 5α-reductase inhibitors (e.g., finasteride, dutasteride), combination α-adrenergic blockers and 5α-reductase inhibitors, anti-muscarinic agents (e.g., darifenacin, solifenacin, oxybutynin), and phosphodiesterase-5 inhibitors (e.g., tadalafil). (1)

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. (4) In the perioperative period, TURP is associated with risks of any operative procedure (e.g., 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%).”5 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). 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 Hyperplasia

Measure

Outcome Evaluated

Description

Clinically Meaningful

Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) (6)

Ejaculatory function

Patient-administered, 4-item scale

Sexual Health Inventory for Men (SHIM) (7)

Erectile function

Patient-administered, 5-item scale; final score range, 1 (worst symptoms) to 25 (fewest symptoms)

Minimum of 3-point Change (1,8)

International Prostate Symptom Score (IPSS) (3)

Severity of lower urinary tract Symptoms

Patient-administered, 8-item scale

Benign Prostatic Hyperplasia Impact Index (BPH-II) (9,4)

Effect of urinary symptoms on health domains

Patient-administered, 4-item scale; final score range, 0 (best) to 13 (worst)

Minimum of 0.4-point Change (8)

Regulatory Status

One implantable transprostatic tissue retractor system has been cleared for marketing by the FDA through the 510(k) process. The NeoTract UroLift System UL400 (NeoTract, Pleasanton, CA) received clearance in December 2013 (after receiving clearance through the FDA’s de novo classification process in March 2013; K130651/DEN130023). In March 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 benign prostatic hyperplasia in men age 50 years and older. FDA product code: PEW.

Rationale:

This policy was originally developed in June of 2015 and has been updated with searches of scientific literature through September 2016. The following is a summary of the key literature to date.

Randomized Controlled Trials

BPH6 Study

In 2015, Sonksen et al. reported results of a multicenter randomized controlled trial (RCT) comparing the prostatic urethral lift procedure with Transurethral resection of the prostate (TURP) among men aged 50 and over with lower urinary tract symptoms secondary to benign prostatic obstruction. (10) Eligible patients had an International Prostate Symptom Score (IPSS) above 12, a peak urinary flow rate (Qmax) of 15 mL/s or less for a 125-mL voided volume, a post void residual volume less than 350 mL, and prostate volume of 60 cm3 or less on ultrasound. The study used a novel composite end point, referred to as the BPH6, which included lower urinary tract symptom relief measured by the IPSS score, recovery experience measured on a visual analog scale (VAS), erectile function measured by the Sexual Health Inventory for Men (SHIM) scale, ejaculatory function measured by the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD), continence preservation measured by the Incontinence Severity Index (ISI), and safety measured by no treatment related adverse event greater than grade 1 on the Clavien-Dindo classification system. Patients were considered treatment responders if they met all 6 composite criteria. The study used a noninferiority design with a margin of 10% for the BPH6 primary end point. Study investigators modified 2 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 VAS from 80 to 70.

Ninety-one patients were randomized to TURP (n=45) or prostatic urethral lift (n=46). Ten patients in the TURP group and 1 patient in the PUL group declined treatment, leaving an analysis group of 80 subjects. 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, with the exception of MSHQ-EjD Function score. For procedure recovery, 82% of the prostatic urethral lift 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 prostatic urethral lift 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 prostatic urethral lift 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, Benign Prostatic Hyperplasia Impact Index (BPH-II) score, and Qmax over time. IPSS, Qmax, and post void residual volumes were better for the TURP group than the prostatic urethral lift group. The TURP group demonstrated declines in ejaculatory function (average MSHQ-EjD score) compared with baseline (9 at baseline vs 5.6 at 12-month follow-up; p<0.001), while the prostatic urethral lift group demonstrated a slight improvement (11 at baseline vs 11.9 at 12-month follow-up, p=0.03) for an overall difference between groups of -5.0 (95% confidence interval [CI], -6.9 to -3.1; p<0.001). Intention-to-treat (ITT) analyses were not reported.

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. (11) 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 randomized to prostatic urethral lift (n=140) or sham control (n=66) and evaluated at 3 months post procedure for the study’s primary efficacy end point. After that, all patients were unblended 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 post procedure 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.

McVary et al. reported on sexual function outcomes in a subset of patients from the LIFT study. (12) 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 post procedure. (13) Crossover (unblinded) patients had a change in IPSS score from 23.4 to 12.3 at 3 months post procedure 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.

In 2015, Roehrborn et al. reported 3-year results from patients randomized to prostatic urethral lift in the LIFT study. (14) After exclusion of 11 subjects who were lost to follow-up, 36 subjects who either had missing data, protocol deviations, medication treatment for benign prostatic hyperplasia (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 (66%) of the original 140 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. No analyses were performed to assess how sensitive the results were to changes in the assumptions about the considerable amount of missing data.

Noncomparative Studies

Other noncomparative studies described outcomes after the prostatic urethral lift procedure in sample sizes ranging from 17 to 102. (15-19) The study reporting the longest follow-up was by Chin et al., which reported outcomes for 64 men at 6 Australian institutions up to 24 months post procedure. (15) At the time of publication, 33 patients had reached 24 months of follow-up. At 24 months, patients had an improvement in IPSS score of -9.2 compared with baseline. Other outcome parameters, including quality of life scores, BPH-II score, and Qmax, had similar magnitudes of improvement at 24 months immediately post procedure.

Systematic Reviews

Several systematic reviews have been published. They include a similar set of trials and noncomparative studies.

In 2015, Perera et al. reported results of a systematic review and meta-analysis (20) of studies reporting outcomes after the prostatic urethral lift procedure, which included 7 prospective cohort studies (24), 1 crossover study (Cantwell et al.), (13) and the LIFT RCT (Reorhborn et al., (11) McVary et al. (12). The pooled standardized mean gain (SMG) estimates for prostate symptoms scores (IPSS and BPH-II) and sexual health scores used responses from 452 to 680 patients. SMG for prostatic symptoms scores ranged from -1.3 (95% CI, -1.4 to -1.2) and -1.6 (95% CI, -1.7 to -1.3), which translated into a clinically meaningful improvement. The SGM 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 2016, Jones, et al. performed a systematic review of UroLift studies with at least 12 months of follow-up. (25) Seven studies were identified, which included 4 noncomparative studies (Woo et al., (17) Chin et al., (15) McNicholas et al. (14) Bozkurt et al. (26), 1 crossover study (Cantwell et al., and 2 RCTs; LIFT (19) and BPH6 (23)). The review 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 mean peak urinary flow rate (Qmax) increased from 8.4 mL/s to 11.8 mL/s, mean IPSS improved from 24.1 to 14, mean quality of life (QOL) 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. (27) The NICE External Assessment Centre (EAC) performed a literature search and data synthesis to support development of the guidance. Studies selected were the same studies included in Perera et al. (20) except for the exclusion of Hoffman et al. (28) and the inclusion of Abad et al. (11) in the analysis. Comparators for the review were TURP and holmium laser enucleation of prostate (HoLEP). When the literature search was performed, there were no studies directly comparing PUL to either TURP or HoLEP. Therefore, the NICE EAC extracted data from a TURP versus HoLEP systematic review to perform a “pragmatic indirect comparison” of these comparators to prostatic lift procedures. The conclusion of the review was that PUL provides significant improvement in IPSS, BPH-II, and QOL (estimates of effect similar to Perera et al. but with improvements that were smaller than those seen with TURP or HoLEP; however, the PUL procedure was associated with a slight improvement in erectile or ejaculatory function.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

In 2014, the National Institute for Health and Care Excellence published interventional procedural guidance on urethral lift implants to treat lower urinary tract symptoms secondary to benign prostatic hyperplasia. (21) These guidelines state: “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 provided that normal arrangements are in place for clinical governance, consent and audit.”

American Urological Association (AUA)

The 2010 (reaffirmed 2014) American Urological Association guideline on the management of BPH does not address the prostatic urethral lift procedure. (22). However, the AUA noted the following on their website in 2015: “The most current American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH) (originally published in 2010) was reviewed and validity confirmed in 2014 and does not mention the Urolift® procedure as a treatment for BPH. Because literature on new technologies may not be available for review during the stringent AUA guidelines development process, the following disclaimer statement is included in the Guideline addressing this possibility. “Although guidelines are intended to encourage best practices and potentially encompass available technologies with sufficient data as of close of the literature review, they are necessarily time-limited. Guidelines cannot include evaluation of all data on emerging technologies or management, including those that are FDA-approved, which may immediately come to represent accepted clinical practices. For this reason, the AUA does not regard technologies or management which are too new to be addressed by this guideline as necessarily experimental or investigational.” The AUA also notes that Urolift should not be considered investigational but an appropriate therapeutic tool used by urologists. They note “The clinical effectiveness has been proven by virtue of going through the Current Procedural Terminology (CPT) approval process”.

The Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU)

The SUFU (23) notes the following in a 2015 document addressing the urethral lift procedure: “While most men are well served with medication, many men still require surgical intervention due to lack of an adequate response to pharmacologic management. Of those men requiring intervention, a selected group will benefit from the prostatic urethral lift procedure as a less invasive option that can preserve their bladder health while not risking sexual dysfunction or incontinence. SUFU finds the prostatic urethral lift procedure to be a well-studied, medically necessary option for our patients suffering from BPH. It has been approved by the FDA and we do not consider it to be investigational.”

In 2015, NICE published a medical technology guidance on use of UroLift for treating lower urinary tract symptoms of benign prostatic hyperplasia. (27) The guidelines state: “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 men 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.”

Summary of Evidence

The evidence for prostatic urethral lift in patients with lower urinary tract obstruction symptoms due to benign prostatic hypertrophy (BPH) includes 2 randomized controlled trials (RCTs) and a number of non-comparative studies. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment related morbidity. The LIFT trial reported that the prostatic urethral lift procedure is associated with greater improvements in lower urinary tract symptoms than medical management, without worsened sexual function. One publication from this trial reported that functional improvements were durable over a 3-year follow-up in a subset of patients. Another RCT compared the prostatic urethral lift procedure with transurethral resection of the prostate (TURP) and reported that the prostatic urethral lift was noninferior for the study’s composite end point, which included multiple measures of symptoms and complications combined into a single score. While TURP was associated with greater improvements in urinary tract obstruction symptom outcomes, it was also associated with greater declines in sexual function than the prostatic urethral lift.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

52441, 52442

HCPCS Codes

C9739, C9740

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. Jul 19 2012; 367(3):248-257. PMID 22808960

2. Barry MJ, Fowler FJ Jr, O'Leary MP, et al. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. Nov 1992; 148(5):1549-1557; discussion 1564. PMID 1279218

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

4. (AUA) AUA. American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH). 2010; https://www.auanet.org. Accessed July 22, 2015.

5. Reich O, Gratzke C, Bachmann A, etal. 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):246-249. PMID 18499179

6. 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):805-809. PMID 17482908

7. 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):307-319. PMID 15875061

8. 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):1770-1774. PMID 7563343

9. Barry MJ, Fowler FJ, Jr., O'Leary MP, et al. Measuring disease-specific health status in men with benign prostatic hyperplasia. Measurement Committee of the American Urological Association. Med Care. Apr 1995; 33(4 Suppl):AS145-155. PMID 7536866

10. 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. Apr 30 2015. PMID 25937539

11. 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):2161-2167. PMID 23764081

12. 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):279-287. PMID 24119101

13. 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):615-622. PMID 24765680

14. 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):7772-7782. PMID 26068624

15. 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

16. McNicholas TA, Woo HH, Chin PT, et.al. Minimally invasive prostatic urethral lift: surgical technique and multinational experience. Eur Urol. Aug 2013; 64(2):292-299. PMID 23357348

17. 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):568-575. PMID 22172161

18. 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):82-88. PMID 21554526

19. 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):7094-7101. PMID 24529008

20. 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):704-713. PMID 25466940

21. (NICE) NIfHaCE. Nice Interventional Procedural Guidance IPG475: Insertion of Prostatic Urethral Lift Implants to Treat Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. 2014; Available at: < http://www.nice.org>. Accessed July 22, 2015.

22. American Urological Association (AUA). Guideline: Management of Benign Prostatic Hyperplasia. 2010, reaffirmed 2014; Available at: < http://www.auanet.org>. Last accessed October 2015.

23. The Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU). Available at: <http://www.sufuorg.com>. Accessed October 2015.

24. 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):584-591. PMID 23985459

25. Jones P, Rajkumar GN, Rai BP, et al. Medium-term Outcomes of Urolift (Minimum 12 Months Follow-up): Evidence from a Systematic Review. Urology. May 18 2016. PMID 27208817

26. 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):202-206. PMID 26613256

27. 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. Jan 30 2016. PMID 26832146

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

29. Prostatic Urethral Lift. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2016 August) Surgery 7.01.151.

Policy History:

Date Reason
10/15/2017 Reviewed. No changes.
12/1/2016 Document updated with literature review. Coverage unchanged.
12/1/2015 Document updated with literature review. The coverage position was changed to consider the UroLift system medically necessary for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) when meeting all the following criteria: men age 50 and older, prostate sizes no greater than 80 grams per ultrasound, international prostate symptom score ≥ 13, peak flow rate (Qmax) ≤ 12mLs, no obstructive median lobe, no active urinary tract infection, when conservative management options have been unsuccessful, or are not appropriate, and when surgical intervention is indicated.
6/15/2015 New medical document. Prostatic urethral lift (PUL) for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH)), including but not limited to the use of the UroLift® System (transprostatic permanent delivery device and implant), is considered experimental, investigational and/or unproven.

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