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Surgical and Minimally Invasive Treatments for Urinary Outlet Obstruction due to Benign Prostatic Hyperplasia (BPH)
MA11.004r

Policy

This policy uses coverage criteria primarily based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents. In the absence of fully established coverage criteria from these Medicare coverage documents for a specific medical service or item, the criterion/indication/service indicated by an asterisk below (*) is based on internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, regulatory status, and/or expert opinion.

MEDICALLY NECESSARY

SURGICAL AND MINIMALLY INVASIVE TREATMENT
The surgical and minimally invasive treatment of urinary outlet obstruction due to benign prostatic hyperplasia (BPH) is considered medically necessary and, therefore, covered when all of the following criteria are met*:
  • One of the following surgical or minimally invasive treatments is utilized:
    • Transurethral resection of the prostate (TURP)
    • Holmium laser ablation of the prostate (HoLAP)
    • Holmium laser enucleation of the prostate (HoLEP)
    • Holmium laser resection of the prostate (HoLRP)
    • Photoselective vaporization (PVP)
    • Transurethral electrovaporization of the prostate (TUVP)
    • Transurethral microwave thermotherapy (TUMT)
    • Transurethral incision of the prostate (TUIP)
    • Simple (subtotal) prostatectomy
*Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: American Urological Association (AUA) Guideline – 2023).

  • The individual is 45 years or older with one of the following conditions attributed to BPH*:
    • Mild-to-moderate lower urinary tract symptoms (LUTS) (e.g., increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying) refractory to medication or is unwilling to take daily medication
    • Renal insufficiency
    • Refractory urinary retention
    • Recurrent urinary tract infections (UTIs)
    • Recurrent bladder stones or gross hematuria
*AUA BPH Guideline 2023.
​
  • The individual has a prostate-specific antigen (PSA) blood test that meets both of the following criteria:
    • Performed within 12 months of the procedure
    • Resulted in a value of 2.5 ng/mL or less for individuals who are up to and including 60 years of age and 4.0 ng/mL or less for individuals who are over 60 years of age. *National Cancer Institute: PSA Test; NCCN Guidelines for Patients: Early-Stage Prostate Cancer​
  • The individual has a peak urine flow rate (Qmax) less than or equal to 12 cc/sec on a voided volume that is greater than 125 cc. *Liu et al. (2016); Chung and van Mastrigt (2009)​
  • .The individual has failed a trial of satisfactory voiding with medication (alpha-blocker and/or alpha-reductase inhibitor) or is intolerant to medication (alpha-blocker and/or 5-alpha-reductase inhibitor). *AUA BPH Guideline 2023​
PROSTATIC URETHRAL LIFT
Prostatic urethral lift (i.e., UroLift) for the treatment of urinary outlet obstruction due to BPH is considered medica​lly necessary and, therefore, covered when all of the following criteria are met:
  • The individual is age 45 years or older and has a diagnosis of LUTS secondary to BPH (e.g., increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying) that interfere with activities of daily living. *US Food and Drug Administration (FDA) 510(k) notification: K232558
  • The individual has a peak urine flow rate (Qmax) less than or equal to 12 cc/sec on a voided volume that is greater than 125 cc. *Liu et al. (2016); Huang Foen Chung and van Mastrigt (2009).
  • The individual's symptoms are caused by enlargement of the lateral or median lobes of the prostate and a prostate volume that is less than or equal to 100 cc. *AUA BPH Guideline 2023; FDA 510(k) notification: K193269; Roehrborn et al. (2013)
  • The individual has normal renal function. *Clinical trial inclusion/exclusion criteria.
  • The individual has had an adequate trial of, but is refractory to or intolerant of, the usual prescribed BPH medication. *AUA BPH Guideline 2023.
  • The individual is a poor candidate for other surgical interventions for BPH, or the individual opts to undergo a minimally invasive procedure. *AUA BPH Guideline 2023.​
  • The individual does not have a contact dermatitis nickel, titanium, or stainless steel allergy. *Manufacturer site: Urolift.
  • The individual has had appropriate testing to exclude diagnosis of prostate cancer. *FDA 510(k) notification: K232558 and K133281.
AQUABLATION (WATER JET-HYDROSECTION)
Water-jet hydrosection (Aquablation) for the treatment of urinary outlet obstruction due to BPH is considered medically necessary and, therefore, covered once per lifetime when all of the following criteria are met:
  • The individual has a​ prostate volume of 30 to 150 cc and persistent moderate to severe symptoms despite maximal medical management including ALL of the following attributed to BPH:
    • The individual has an International Prostate Symptom Score (IPSS) of equal to or greater than 12. 
    • The individual has a peak urine flow rate (Qmax) less than or equal to 15 mL/sec
    • The individual has had a failure, contraindication, or intolerance to at least 3 months of conventional medical therapy for LUTS/BPH (e.g., alpha-blocker, phosphodiesterase type 5 [PDE5]  inhibitor, finasteride/dutasteride). 
  • The individual has none of the following:
    • Severe obesity (body mass index [BMI] ≥42 kg/m2)
    • Known or suspected prostate cancer or a PSA greater than 10 ng/mL unless there has been a negative prostate biopsy within the past 6 months
    • Bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum
    • Active urinary tract infection or systemic infection
    • Treatment for chronic prostatitis
    • Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture
    • Damaged external urinary sphincter
    • Known allergy to device materials
    • Inability to safely stop anticoagulants or antiplatelet agents preoperatively​
WATER VAPOR THERMOTHERAPY (REZŪM)*
Transurethral destruction of prostate tissue by radiofrequency-generated water vapor thermotherapy (Rezū​m) for the treatment of urinary outlet obstruction due to BPH in individuals 45​ years or older is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • Prostate gland volume is ≤80 grams​.
  • The individual has an IPSS ≥12. 
  • The individual has had appropriate testing to exclude diagnosis of prostate cancer.​
  • The individual has failed a trial of satisfactory voiding with medication (alpha-blocker and/or alpha-reductase inhibitor) or is intolerant to medication (alpha-blocker and/or 5-alpha-reductase inhibitor).
*FDA 510(k): K180237; McVary et al. (2016); McVary et al. (2021).

NOT MEDICALLY NECESSARY

The following obsolete medical services are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury:
  • Visual laser ablation of the prostate (VLAP) *Planz et al. (2003)
  • Interstitial laser coagulation (ILC) *Kursh et al. (2003); Liedberg et al. (2003)
  • Transurethral ultrasound–​guided laser-induced prostatectomy (TULIP) *AUA BPH Guideline 2023
  • Water-induced thermotherapy (WIT) *Breda and Isgrò (2002); Muschter (2000); Schorsch (2000)
  • Transurethral needle ablation (TUNA) *Bouza et al. (2006); Boyle et al. (2004); Hill et al. (2004); Cimentepe et al. (2003); Law  et al. (2019)
EXPERIMENTAL/INVESTIGATIONAL

The following procedures are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness in the treatment of urinary outlet obstruction due to BPH has not been established by review of the available published peer-reviewed literature:
  • Balloon dilation of the prostate *Zhou et al. (2022); Fang (2022)
  • Transurethral ethanol ablation of the prostate (TEAP) *El-Husseiny and Buchholz​ (2011); Magno et al. (2008); Grise et al. (2004); Plante et al. (2007); Frieben et al. (2010)
  • High-intensity focused ultrasound (HIFU) ablation of prostate *Sciacqua et al. (2023); Garcia-Becerra et al. (2024)
  • Prostate artery embolization (PAE) *Kuang et al. (2017); Wang et al. (2016); Carnevale et al. (2016); Brown et al. (2024); Ini' (2024);  Radwan et al. (2020); Abt et al. (2021); AUA BPH Guideline 2023
  • Transperineal laser ablation (TPLA) *Sessa et al. (2023); Canat et al. (2023); Bertolo et al. (2023)
  • Temporarily implanted nitinol device (iTIND) *AUA BPH Guideline 2023; Amparore et al. (2023); Chughtai et al. (2021); Elterman et al. (2023); Franco et al. (2021) 
  • Temporary prostatic stent (e.g., Spanner™​) *Dineen et al. (2008); Grimsley et al. (2007); Goh et al. (2013); Cambio et al. (2022)
  • Drug-coated balloon​ catheter system (e.g., ​Optilume®) *Kaplan et al. (2021); Pichardo et al. (2023); Kaplan et al. (2023a); Kaplan et al. (2023b)
  • Transurethral ultrasound ablation (TULSA)​​ *Dora et al. (2022); Lumiani et al. (2021); Elterman et al. (2021); Mäkelä et al. (2023); Zhou et al. (2023); Muschter et al. (2023); Anttinen et al. (2024); Viitala et al. (2022)
  • Permanent nitinol urethral expansion device (e.g., ProVee System​, ​Zenflow Spring System)​​ *Kaplan​ et al. (2026); FDA SSED; Elterman et al. (2023); Gilling et al. (2024a); Gilling et al. (2024b)​
REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

This policy is consistent with Medicare's coverage determination for minimally invasive surgical techniques for benign prostatic hyperplasia (BPH). The Company's payment methodology may differ from Medicare.

Serum prostate-specific antigen (PSA) level and prostate size should not be used as the sole basis of treatment recommendations.
​
BENEFIT APPLICATION
​
Subject to the terms and conditions of the applicable Evidence of Coverage, surgical and minimally invasive treatments for urinary outlet obstruction due to BPH are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.​

However, services that are identified in this policy as not medically necessary and experimental/investigational are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The use of devices in the minimally invasive treatment of urinary outlet obstruction due to BPH should be in accordance with all of the FDA-approved labeling requirements and/or criteria.

Description

Urinary outlet obstruction is defined as difficulty in the passage of urine from​​ the bladder to the urethra caused by compression or resistance on the bladder outflow channel at any location from the bladder neck to the urethral meatus. In male individuals, this can be caused by benign prostatic hyperplasia (BPH). BPH is a common, age-related, noncancerous condition in men that is characterized by an increase of epithelial and stromal cells in the periurethral area of the prostate. This increase in cells causes an enlargement of the prostate gland. This pathologic change is important because of the proximal anatomical relationship between the prostate and the bladder neck. The condition generally involves lower urinary tract symptoms (LUTS), which may include increased urinary frequency, urgency, incontinence, or straining; nocturia; decreased and intermittent force of the stream; hematuria; and the sensation of incomplete bladder emptying. Given the substantive symptomatic impact of urinary outlet obstruction, symptomatic appraisal of interference with activities of daily living is a crucial aspect of evaluation. In an effort to quantify the severity of symptomatic BPH, a urodynamic investigation (e.g., urine flow rate assessment) may be performed.

Treatment for BPH includes watchful waiting (e.g., active surveillance), medical management with pharmacotherapy (e.g., alpha-blockers, 5-alpha-reductase inhibitors), minimally invasive treatments (e.g., transurethral microwave thermotherapy [TUMT]), and surgery [e.g., transurethral resection of the prostate (TURP), laser treatments]). If there is minimal interference with activities of daily living and no evidence of prostate enlargement, watchful waiting may be utilized. Medical management may be indicated for individuals with uncomplicated BPH or moderate to severe symptoms, and individuals who are waiting for surgery, unwilling to undergo surgery, or are poor surgical candidates. Individuals with BPH who have complications such as acute urinary retention, recurrent urinary tract infections, hematuria, bladder stones, or renal insufficiency or failure due to BPH may be treated surgically. Untreated BPH may worsen over time and increase the risk of stones, infection, or kidney failure. The choice of treatment for urinary outlet obstruction due to BPH should be based on the individual's presentation and anatomy, the surgeon's level of training and experience, and a discussion of the potential benefits and risks for complications.

The primary goal of treatment is to alleviate bothersome symptoms (i.e., symptoms that interfere with activities of daily living) that result from prostatic enlargement. More recently, treatment has been focused on altering disease progression and preventing complications associated with BPH. Standard surgical treatments such as TURP, transurethral incision of the prostate (TUIP; in which an incision is made where the prostate meets the bladder), and open prostatectomy may be accompanied by undesirable complications such as blood loss, need for transfusion, salt imbalances from fluid absorption, and side effects such as incontinence and retrograde ejaculation. Newer surgical techniques that use lasers, as well as minimally invasive techniques that use various sources of energy such as heat, microwaves, radiofrequency, and ultrasound, have been developed.

STANDARD TREATMENTS

SURGICAL TREATMENTS
Transurethral Resection of the Prostate (TURP)

TURP is the standard treatment for BPH against which all treatments are measured. TURP involves removing the core of the prostate through the urethra using instruments and electrodissection. An electrified wire loop removes pieces of prostatic tissue and coagulated blood. TURP is performed under general or spinal anesthesia and requires a hospital stay.

Simple Prostatectomy

Simple prostatectomy is a standard surgical procedure that can be performed open, laparoscopically​, or robotically, in which the obstructing prostate tissue is removed through a lower abdominal incision using a suprapubic (through the bladder) or retropubic (through the prostate capsule) approach. The obstructing tissue that is blocking the flow of urine is excised in one piece and the prostate capsule is removed. Simple prostatectomy is a treatment option for relieving bladder outlet obstruction for individuals with prostate glands greater than 75 to 100 grams.

Transurethral Incision of the Prostate (TUIP)

TUIP is usually limited to small prostate glands of 30 grams or less, in which two lengthwise internal incisions in the prostate near the bladder are made, opening the bladder neck and prostate, reducing pressure on the urethra. TUIP can be done in an outpatient setting under regional or general anesthesia.

THERMAL TREATMENT
Transurethral Electrovaporization of the Prostate (TUVP)

TUVP vaporizes the enlarged prostate tissue, destroying it by coagulation and allowing it to slough away over several weeks. TUVP steams the tissue away using high heat, and dries out the tissue using lower heat. The advantages of TUVP include earlier posttreatment catheter removal and fewer bleeding-related complications when compared with TURP. It is usually an outpatient procedure. Evidence in the available published peer-reviewed literature demonstrates the safety and effectiveness of TUVP for the treatment of BPH (Poulakis et al., 2004).

LASER TREATMENTS
Laser treatment procedures involve a laser fiber that is passed into the prostatic channel under telescopic guidance. The laser is then used, through vaporization or ablation techniques, to destroy the obstructing portions of the prostate with heat. With laser vaporization, high instantaneous heat is created to vaporize or steam away prostate tissue. Lower laser energy is applied with laser ablation, which heats the tissue enough to dry it out and allows it to shrink and slough away with time.

Visual Laser Ablation of the Prostate (VLAP)

VLAP delivers a laser energy that is focused, without direct contact with the prostate, on the enlarged prostatic tissue and causes thermal injury or coagulation necrosis of the tissue. The primary mechanism of tissue destruction is coagulation rather than vaporization, and the coagulated tissue sloughs away over several weeks following the procedure. VLAP requires a posttreatment catheterization from several days to several weeks. Community practice suggests that VLAP is not commonly used for the treatment of urinary outlet obstruction due to BPH, as laser vaporization is now used.

Interstitial Laser Coagulation (ILC)

ILC utilizes a fiberoptic laser probe that is inserted through a cystoscope into the prostate at fixed points. Laser energy is applied to coagulate each area of obstructing prostate tissue, producing coagulation necrosis. In contrast to other laser procedures, in which coagulation necrosis occurs at the urethral surface, ILC delivers laser energy directly into the tissues and produces coagulation necrosis inside the enlarged prostatic tissue. The treated tissue is absorbed over a period of several weeks. Community practice suggests that ILC is no longer considered a standard or an option for the treatment of urinary outlet obstruction due to BPH.

Transurethral Ultrasound-Guided Laser-Induced Prostatectomy (TULIP)

TULIP was one of the first laser treatments used for BPH. A laser probe is housed between two ultrasound transducers that are used for real-time scanning to position the laser while it is being used. Coagulation necrosis of the prostate tissue produces shrinking over several weeks following TULIP. TULIP has been replaced by other laser techniques that have fewer side effects, shorter posttreatment catheterization times, and fewer urinary symptoms. TULIP is not mentioned in any of the evidence-based BPH guidelines. Because this treatment appears to be outdated, results of controlled trials are no longer considered. Community practice suggests that TULIP is no longer considered a standard or an option for the treatment of urinary outlet obstruction due to BPH.

Holmium laser

Holmium laser treatments of the prostate use a holmium laser fiber and a specially adapted resectoscope to ablate, resect, or enucleate enlarged prostatic tissue. Relief of obstruction is immediate. Holmium lasers are among the most common laser technologies used to treat prostate disease. The holmium laser has the ability to coagulate tissue simultaneously with tissue incision, ablation, resection, or enucleation. This advantage reduces intraoperative blood loss as well as postoperative bleeding. The American Urological Association (AUA, 2010) states that holmium laser treatments are appropriate and effective treatment alternatives to TURP and open prostatectomy in individuals with moderate to severe LUTS due to BPH, and/or who are significantly bothered by these symptoms (i.e., interfere with activities of daily living). Additionally, according to the AUA, these treatments have been associated with shorter posttreatment catheterization time and shorter length of hospital stay.
  • Holmium laser ablation of the prostate (HoLAP) delivers laser energy at a wavelength of infrared range, which is primarily absorbed by water. HoLAP is intended to be comparable to TURP, in that the prostatic lobes may be vaporized down to a surgical capsule resulting in a TURP-like effect. HoLAP does not yield tissue for histologic analysis. A controlled trial reported that although HoLAP took longer to perform than TURP, LUTS due to BPH and physiological measures improved to a similar degree after HoLAP and TURP (Mottet et al., 1999).
  • Holmium laser resection of the prostate (HoLRP) utilizes a specially adapted resectoscope to resect prostate tissue into pieces small enough to be removed with bladder irrigation and grasping forceps or a modified resectoscope loop. Improvements in LUTS due to BPH obtained by using HoLRP are comparable to TURP (Gilling et al., 1999; Ruszat et al., 2008).
  • Holmium laser enucleation of the prostate (HoLEP) is typically used for larger glands that previously would have been treated with an open prostatectomy. An entire prostatic lobe can be separated from connective tissue and deposited in the bladder. The tissue is then extracted from the bladder. HoLEP has been evaluated in clinical trials and compared favorably with TURP in meta-analyses and system reviews (Kuntz and Lehrich, 2002; Elzayat and Elhilali, 2007; Naspro et al., 2009; Burke et al., 2010).
Photoselective Vaporization (PVP)

PVP uses a potassium-titanyl-phosphate (KTP) laser to vaporize prostate tissue. KTP laser wavelengths penetrate only 1 to 2 mm, and the vaporization process may help avoid the perioperative side effects such as tissue sloughing. Additional reported potential advantages of PVP include virtually bloodless tissue ablation, shorter length of hospital stay, and shorter posttreatment catheterization times. As compared with TURP, surgical treatment of high-risk populations such as individuals taking anticoagulants may be possible with PVP (Burke et al., 2010; Ruszat et al., 2008). PVP is an appropriate and effective treatment alternative to TURP and open prostatectomy in men who have moderate to severe LUTS due to BPH and/or who are significantly bothered by the symptoms (i.e., interfere with activities of daily living).

MINIMALLY INVASIVE TREATMENTS
Although TURP is the most commonly used treatment option for BPH, minimally invasive treatments have been developed that utilize various sources of energy, such as heat, radiofrequency, ultrasound, and microwaves.

Water-Induced Thermotherapy (WIT)

WIT is a minimally invasive treatment in which heated water is circulated through a proprietary closed-loop catheter system to produce coagulative necrosis and secondary ablation of obstructing prostatic tissue. Thermal insulation of the catheter shaft along the penile, bulbous, and membranous urethra, as well as in the sphincter region, prevents unwanted incidental damage of tissue along the urinary tract. According to the Urologic Clinics of North America, along with a review of the available published peer-reviewed literature and clinical guidelines, there is insufficient evidence to support the use of WIT for the treatment of urinary outlet obstruction due to BPH.

Balloon Dilation of the Prostate

This minimally invasive treatment utilizes a flexible balloon catheter that is placed in the urethra at the level of the prostate above the external sphincter. The balloon is then inflated for a short time to distend the prostatic urethra. Currently, the AUA does not recommend the use of balloon dilation of the prostate. Furthermore, the safety and/or efficacy of this procedure cannot be established by review of the available published peer-reviewed literature.

Transurethral Ethanol Ablation (Chemoablation) of the Prostate (TEAP)

TEAP is a minimally invasive treatment that involves injecting absolute ethanol transurethrally into the prostate tissue. The injected ethanol causes cells of the prostate to burst, killing the cells. The prostate shrinks as the necrosed cells are absorbed. Currently, the AUA does not recommend the use of TEAP. Furthermore, the safety and/or efficacy of this procedure cannot be established by review of the available published peer-reviewed literature.

High-Intensity Focused Ultrasound (HIFU) Ablation of Prostate for Treatment of BPH

High-intensity focused ultrasound (HIFU) is a minimally invasive treatment in which targeted high-intensity ultrasound energy is used to create coagulation necrosis in prostate tissue. In contrast to other treatments, the HIFU device is inserted rectally and does not directly contact the prostate or urethra. Posttreatment catheterization time ranges from a few days to more than a week. HIFU has been evaluated for a variety of clinical indications, and the strength and maturity of the evidence differ by condition. Therefore, coverage determinations for HIFU are indication-specific. This policy evaluates only the use of HIFU for the treatment of BPH; conclusions regarding HIFU for BPH should not be interpreted as applying to other indications that may be addressed in separate policies. For the treatment of BPH, the available published peer-reviewed literature is insufficient to establish the safety and/or efficacy of HIFU. Randomized controlled trials (RCTs) comparing HIFU with standard treatments for BPH have not been published. In addition, the AUA considers HIFU investigational for BPH and notes that additional long-term studies are warranted.

Transurethral Ultrasound Ablation (TULSA)

On August 15, 2019, the US Food and Drug Administration (FDA) granted the TULSA-PRO 510(k) marketing clearance. TULSA uses directional, thermal ultrasound to ablate diseased or enlarged prostate tissue. It includes real-time magnetic resonance imaging to deliver precise thermal ablation at a customized volume. Similar to HIFU, TULSA also uses thermal ultrasound to ablate prostate tissue, but the HIFU device is inserted into the rectum and delivers the thermal ultrasound energy through the rectal wall.

The literature that has explored BPH as an indication for TULSA includes a systematic review, retrospective cohort studies, and a prospective cohort study. The systematic review by Dora et al. (2022) reviewed two studies by Lumiani et al. (2021) (N=52) and Elterman et al. (2021) (N=9) that explored the influence of TULSA on functional outcomes; specifically, Lumiani et al. reported that in the subgroup analysis of individuals with BPH and prostate cancer (PCa) (n=24), 20 (83%) participants had improvement at last follow-up, with participants describing reduced rates of nocturia and discontinuation of either permanent catheterization or BPH medication, while four (17%) participants showed no improvement. The authors conclude, “While the results in the present study are promising, a multi-center prospective study incorporating longer follow-up while controlling for baseline [participant] characteristics is needed to definitively establish the safety and efficacy of TULSA as a focal treatment for CaP [prostate cancer], with or without concurrent BPH.” Additionally, Elterman et al. (2021) described improvement in LUTS measured by International Prostate Symptom Score (IPSS) in a subpopulation of men who had prostate cancer and BPH (n=9)—at 12 months post-TULSA, IPSS significantly improved by 58%. International Index of Erectile Function (IIEF)-EF remained stable from 14.6 ± 9.3 at baseline to 15.7 ± 9.0 at 12 months. The authors concluded that larger controlled studies with BPH-specific ablation plans in men seeking treatment for LUTS are warranted. 

A retrospective cohort study not included in the systematic review, such as Mäkelä et al. (2023), included 21 individuals with BPH only, 28 with radiorecurrent PCa, and 40 with primary PCa. The purpose of the study was to characterize the nonperfused volume (NPV) evolution 12 months post-TULSA. NPV is a metric used to measure the extent of tissue necrosis after ablation procedures. Persistent necrotic tissue that does not disappear quickly may increase the risk of bladder outlet obstruction and urinary infections. A higher NPV, or nonperfused volume ratio (NPVR), signals a meaningful improvement in symptoms, and an NPVR of over 80% is often considered as an indicator of therapeutic success in recent studies (Zhou et al., 2023). Mäkelä et al. found at 12 months that most of the necrotic prostate tissue had disappeared in each treatment group. The authors concluded “[Participant] disease characteristics, prostate sizes, and ablation volumes were variable across and within the different treatment cohorts. This could confound the results since underlying physiological mechanisms that influence necrotic tissue removal may not have been properly accounted for… Future research includes confirming these results through a prospective study with more consistent disease characteristics and treatment plans in each study group, and the inclusion of multiple readers. Additionally, a detailed comparison of the correlation between the amount of leftover necrotic tissue and the number of urinary side effects should be directly explored.” The latter comment by the authors highlights the lack of established relationship between the amount of leftover necrotic tissue and LUTS; the authors do not correlate the observed NPV to relevant clinical outcomes.

Other data include two abstracts presented at AUA-moderated poster sessions and published as abstracts in the Journal of Urology (Muschter et al., 2023; Anttinen et al., 2024) as supplements. The full manuscripts were not published in the AUA peer-reviewed journal. In the Muschter et al. abstract, a subset of men with concurrent PCa and BPH, TULSA was applied as a combined therapy; they reported 85% of men with concurrent BPH and PCa experienced symptom relief. It is unclear how symptom relief was measured. Anttinen et al. reported 12-month outcomes for 30 men with BPH from a phase I-2 clinical trial (NCT03350529). Based on the clinical trial page, the primary endpoints of the trial included targeting and treatment accuracy of ablation and safety—all other endpoints were listed as “other outcome measures.” Given that the relevant clinical outcomes were measured as “other outcome measures” and not primary endpoints, it is challenging to have overwhelming confidence in the findings. The authors report between baseline and 12 months median values for measured parameters changed: prostate volume reduced from 51.5 to 31 mL, prostate-specific antigen (PSA) reduced from 3.1 to 1.5 μg/L, postvoid residual volume decreased from 71 to 41 mL, average flowrate increased from 4.1 to 8.9 mL/s, Qmax increased from 11 to17 mL/s, voided volume increased from 211 to 290 mL, IPSS score improved from 16.5 to 4, IPSS Quality of Life (QoL) score improved from 4 to 1, IIEF-5 improved from 15 to 18. These data require publication as a complete manuscript to appropriately evaluate the findings. Additionally, these outcomes must be evaluated with the proper study design to ensure statistical rigor and credibility.

Viitala et al. (2022) published results from a prospective phase I trial including men with LUTS due to BPH in need of surgical intervention (N=10); individuals with PCa were excluded. At 12 months, five of six men with normal ejaculatory function before TULSA reported normal antegrade ejaculations. The authors reported median (IQR) improvement in the IPSS was 82%, from 17.5 (15.3–23.0) at baseline to 4.0 (2.3–6.3) at 12 months. Similarly, the median maximum urinary flow rate improved by 101%, from a median (IQR) of 12.4 (8.8–17.6) mL/s at baseline to 21.8 (17.6–26.5) mL/s at 12 months. There were no changes in continence, sexual, erectile, or bowel functions. All participants taking BPH medications before TULSA discontinued after TULSA. The authors concluded that further studies with larger cohorts are needed to confirm the observed results. The same clinical trial that generated the Anttinen et al. (2024) abstract generated the current paper; therefore, the results the authors reported are potentially biased and should be regarded as exploratory because the function outcomes were not analyzed as primary endpoints.

A prospective early phase II study (NCT03350529) by Viitala et al. (2025) published data on the primary efficacy endpoints of improvements in IPSS and Qmax at 12 months and the primary safety endpoint of the frequency and severity of adverse events recorded over a 12‐month follow‐up period. The authors note that a formal power calculation was not performed. The median (IQR) IPSS improved from 17 (12–22) at baseline to 4 (2–7) at 12 months (P<0.001). Between baseline and 12 months, the median (IQR) Qmax improved from 11.1 (7.9–14.6) to 18.3 (15.3–23.9) mL/s (P<0.001). Thirteen adverse events (AEs) were recorded, including 11 Grade II events (urinary tract infections/retentions) and one Grade IIIb event (epididymitis requiring drainage under general anesthesia). All AEs resolved during follow‐up. Further research is needed to assess TULSA's performance to comparators, validate these results, and evaluate durability.​​​

In many of the studies on TULSA, the populations included are men who have both PCa and BPH concurrently; consequently, this combination introduces potential confounding, interaction effects, and heterogeneity, which may obscure or ostensibly alter the relationship between BPH and the relevant clinical outcomes. Another limitation of the available evidence is that when relevant clinical outcomes were reported, most of the studies were not designed to rigorously analyze those variables (e.g., IPSS, Qmax, IIEF, PVR); they were secondary endpoints that serve an exploratory purpose. The majority of papers had small sample sizes and were retrospective design. There are currently no comparative studies. The aggregate of evidence is insufficient to draw conclusions about the efficacy of TULSA for the treatment of BPH.​

Transurethral Needle Ablation (TUNA) of the Prostate (Also Called Transurethral Radiofrequency Needle Ablation [RFNA])

This minimally invasive treatment delivers selective thermal energy to the prostate using two 18-gauge needles at the end of a TUNA catheter. A lens inside the catheter is used to guide the placement of the catheter into the urethra, where the needles are advanced to cause heat-induced coagulation necrosis in the prostate parenchyma. The prostate shrinks as the necrosed cells are absorbed. The AUA recommends the use of TUNA as an appropriate and effective treatment alternative for bothersome (i.e., interfering with activities of daily living), moderate, or severe LUTS due to BPH. TUNA has been compared favorably with TURP in clinical trials and meta-analysis (Bouza et al., 2006; Boyle et al., 2004; Hill et al., 2004). Although the improvement of LUTS due to BPH does not reach the same level as TURP, fewer adverse events (e.g., incontinence, retrograde ejaculation) are demonstrated.

Transurethral Microwave Thermotherapy (TUMT)

TUMT is a minimally invasive treatment that begins by introducing a coolant into the urethra through a transurethral probe, which cools the urethra, followed by a microwave emission that heats and ultimately ablates prostatic tissue. The AUA recommends the use of TUMT as an appropriate and effective treatment alternative for bothersome (i.e., interfering with activities of daily living), moderate, or severe LUTS due to BPH (Hoffman et al., 2007).

Prostatic Urethral Lift (UroLift)

The UroLift system is a minimally invasive implant developed to treat LUTS related to urinary outflow obstruction secondary to BPH in men 50 years of age or older. In this procedure, permanent implants (made from common implantable materials: nitinol, stainless steel, and polyethylene terephthalate) are delivered transprostatically to retract the enlarged lateral lobes of the prostate. This procedure dilates the prostatic urethra, leading to improvement in LUTS symptoms without the need for surgical resection or the application of thermal energy to the prostate. Current evidence for this intervention includes one randomized sham-controlled trial (n = 206) published by Roehrborn et al. (2013). These authors found that at 12-month follow-up, both objective and subjective outcomes were significantly improved in individuals undergoing the UroLift procedure with no adverse impact to sexual function reported among any of the participants. An RCT directly comparing UroLift to TURP was completed in January 2016. The investigators concluded that individuals who underwent prostatic urethral lift responded significantly better than those who underwent TURP as treatment for BPH.

Water-Jet Hydrosection (Aquablation)

The aquablation system is a novel surgical treatment for BPH, developed by Procept BioRobotics, that delivers a high-velocity saline stream under precise electrochemical control and live ultrasound guidance to ablate prostatic glandular tissue. The surgeon-guided aquabeam ablates the prostatic tissue accurately following a preprogrammed routine, and the ablated prostatic tissue is simultaneously collected for postprocedure analysis. 

A prospective, multicenter RCT (Gilling et al., 2015) assessed outcomes for individuals with LUTS treated with aquablation to individuals treated by TURP; a primary efficacy endpoint was the difference between groups in the change in IPSS at 6 months in a noninferiority study design. In this pivotal study, the primary endpoints for safety and efficacy ​were assessed at 3 and 6 months, respectively, and participants were followed for up to 3 years to collect long-term clinical data. At 6 months, mean IPSS decreased from baseline by 16.9 points for aquablation and 15.1 points for TURP (mean difference, 1.8 points; P<0.0001 for noninferiority). Gilling et al. (2019) published 2-year outcomes from the original participants in the pivotal study, demonstrating that IPSS score improvement was sustained (14.7 in aquablation and 14.9 in TURP [P=0.834; 95% CI for difference, −2.1 to 2.6]), and Qmax improvement was large in either trial arm (11.2 and 8.6 cc/s for aquablation and TURP, respectively [P=0.1880; 95% CI for difference, −1.3 to 6.4]). Two-year reduction in PVR was 57 and 70 cc for aquablation and TURP, respectively (P=0.3894). PSA decreased significantly in both groups by one point (P<0.01). Gilling et al. (2020) reported trial results at 3 years. They observed that improvements in symptoms and QoL were maintained through 3 years in both treatment groups, and the rate of serious adverse events did not differ between groups at any time point. The 2021 AUA guidelines provide a moderate recommendation for the use of aquablation (Water-Jet Hydrosection) to be offered to individuals with LUTS attributed to BPH, provided prostate volume is between 30 and 80 cc​​. ​

Transurethral Destruction of Prostate Tissue by Radiofrequency-Generated Water Vapor Thermotherapy (Rezūm System)

Radiofrequency-generated water vapor thermotherapy is being evaluated as a treatment for LUTS due to BPH. The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men older than 50 years of age with a prostate volume greater than 30 cm3 and less than 80 cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. Rezūm uses convective radiofrequency water vapor thermal technology to apply thermal energy to prostate tissue through transurethral needle ablation. The system includes a reusable generator and a disposable delivery device kit. The delivery device is similar in size and shape to a cystoscope and allows for direct visualization via a rigid cystoscope lens port, delivery of water vapor through a needle located at the tip, and saline irrigation to facilitate visualization and cool the urethra. The procedure can be performed in an office or outpatient setting. The FDA granted 510(k) marketing clearance for the Rezūm System (K180237) in February 2018.

The seminal publication for transurethral destruction of prostate tissue by radiofrequency-generated water vapor thermotherapy (Rezūm​) was an open-label, sham-controlled study on 197 individuals comparing the difference in the change from baseline between the treatment and control arms at 3 months after ​treatment (McVa​ry et al., 2016). Secondary outcome was the percentage of responders at 3 months. Response was defined as a 30% or greater reduction in the IPSS at 3 months compared to baseline. The Rezūm group demonstrated a decrease in IPSS ​of 11.2 point compared to a 4.3-point decrease in the sham group (P<0.001). Subsequently, McVa​r​y et al. published uncontrolled, open-label crossover data at various intervals: 3 years (2018), 4 years (2019), and 5 years (2020), which reported on longer term outcomes of the original study. Urinary symptoms and QoL remained significantly improved from baseline out up to 5 years. Although the longer term studies observed a high loss of follow-up, over 5 years the surgical retreatment rate was 4.4% and the medication retreatment rate was 11.1%. The AUA considers Rezūm as a treatment modality for individuals with LUTS/BPH provided that the prostate volume is between 30 and 80 cc as a moderate recommendation. ​

Prostate Artery Embolization (PAE) for BPH

Prostate artery embolization (PAE) is a minimally invasive procedure proposed as an alternative to TURP or open prostatectomy for treatment of BPH. PAE for BPH is intended to reduce the blood supply of the prostate gland, causing some of it to undergo necrosis with subsequent shrinkage. The procedure is performed under local anesthesia and sedation using a percutaneous transfemoral approach.​


The IPSS is commonly used to evaluate LUTS; however, it is a subjective, patient-reported measure. Assessment of objective clinical endpoints, including maximum urinary flow rate (Qmax), postvoid residual (PVR), PSA, trial of void following catheter removal​, and complication rates, provides a more comprehensive and reliable evaluation of treatment efficacy.

 

Available evidence indicates that although PAE may yield similar symptom improvement (IPSS) compared with TURP in some analyses, it is generally less effective across objective functional outcomes. For example, the systematic review and meta-analysis by Xiang et al. (2021) reported comparable IPSS outcomes between PAE and TURP but found that PAE was less effective in improving key objective measures, including Qmax, prostate volume, and PSA. Inferior performance on these objective endpoints reduces confidence in the overall clinical effectiveness of PAE.

 

The Cochrane systematic review by Jung et al. (2022), which included six randomized trials comparing PAE with TURP, further highlights uncertainty in the evidence base. The review found very low-certainty evidence for differences in major adverse events and moderate-certainty evidence that PAE is associated with a higher likelihood of retreatment. Regarding sexual health, PAE appeared to have minimal short-term impact on erectile function (low-certainty evidence) and reduce the risk of ejaculatory dysfunction (very low-certainty evidence). Long-term outcomes (13–24 months) demonstrated no meaningful difference in symptom scores (IPSS).

 

Additional context is provided by Sandhu et al. (2024), who conducted a systematic review and meta-analysis to inform the updated AUA guidelines (2023) on evidence-based surgical management of male LUTS due to BPH. The authors concluded:​

​ 

“The panel was unable to find substantial evidence to recommend PAE over more widely available minimally-invasive therapies for the routine treatment of LUTS..."


This conclusion reinforces that current evidence is insufficient to support routine use of PAE outside of select clinical scenarios and highlights ongoing uncertainty regarding its comparative effectiveness.

 

In 2016, Wang et al., in a systematic review and meta-analysis, evaluated the efficacy and safety of PAE on LUTS related to BPH. The authors concluded that data in the studies were insufficient to determine whether or not PAE is as good as TURP. Similar conclusions were reported in a systematic review and meta-analysis in 2017 by Pyo and Cho and Kuang et al.

Brown et al.'s 2024 RCT (N=39) compared the change in prostate size, urodynamic parameters, IPSS findings, and QoL scores between PAE and the combination of tamsulosin and dutasteride therapy as a potential first‐line therapy for obstructive BPH. These outcomes were evaluated as primary endpoints. PAE was significantly more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in individuals with BPH who had not previously been treated. Because this was the first RCT to compare PAE and combined medical therapy in exclusively treatment‐naïve participants, further randomized comparative trials are needed to further validate the role of PAE in mitigating obstructive BPH.

An updated 2024 systematic review by Ini' et al. concluded that QoL and urological symptom scores of the PAE group were comparable to those of the TURP group; however, one of the included RCTs reported 2-year follow-up data following TURP (n=47) and PAE (n=34) and reported that TURP had superior IPSS reduction, maximum urinary flow rate, reduction of postvoid residual urine, and reduction of prostate volume. Adverse events were less frequent after PAE than after TURP. A different RCT (N=30) by Carnevale et al. (2016) compared urodynamic parameters, prostate volume, IPSS for TURP, original PAE (oPAE), or Proximal Embolization First, Then Embolize Distal (PErFecTED) PAE. The authors report that TURP and PErFecTED PAE both resulted in significantly lower IPSS than oPAE, but TURP and PErFecTED​ PAE were not significantly different from one another. TURP resulted in significantly higher Qmax and significantly smaller prostate volume than either original or PErFecTED PAE. Another RCT by Radwan et al. (2020) compared monopolar transurethral resection of prostate (M-TURP) and bipolar transurethral resection of prostate (B-TURP) with PAE and reported the improvement in the IPSS score, the average uroflowmetry (Q-average) score, postvoid residual urine, and prostate volume reduction was statistically significantly better in each of the M-TURP and the B-TURP groups than in the PAE group. The highest quality literature included in Ini' et al.'s systematic review reported inconsistent functional outcome results for PAE, with many of the including RCTs reporting the superiority of TURP compared to PAE. ​

Consistent with these findings, PAE for individuals with prostates 50 cc or larger is assigned only a conditional recommendation with moderate certainty in the evidence by the AUA, indicating that additional evidence could meaningfully change clinical confidence, i.e., that more evidence is needed. The recommendation further underscores that the current evidence base neither comprehensively nor consistently establishes PAE as equivalent to standard surgical therapies. 

Higher quality, sufficiently robust evidence consistently demonstrating equivalence or superiority of PAE across objective, functional endpoints is not currently available; thus, the current evidence base remains limited by low to moderate certainty, heterogeneity in study design, and consistently higher retreatment rates.​​

Transperineal Laser Ablation (TPLA)

Sessa et al. (2023) reviewed seven studies using TPLA between 2014 and 2021. Of these seven preliminary studies, five studies were prospective and monocentric, whereas two studies were retrospective. All studies were single-arm trials. Sample size ranged between 18 and 160. Of the seven studies, only four reported 6-month follow-up results, and three studies reported 12-month follow-up results. Only three studies reported the prostate volume at 3, 6, and 12-month follow-up.

Since this review, Canat et al. (2023) reported findings for a prospective, randomized, controlled, and single center; the study was conducted between November 2021 and February 2023. Fifty individuals were included in the study and were assigned in equal numbers to TURP or TPLA. They were followed up for 1 year. The authors report that TPLA improved LUTS without compromising ejaculatory function.

A 2023 RCT by Bertolo et al. compared 1-month ejaculatory function in men with BPH who received TPLA (N=26) or TURP (N=25). The primary outcome was ejaculatory function measured by the Male Sexual Health Questionnaire - Ejaculatory function domain (EJ-MSHQ). The EJ-MSHQ remained unchanged after TPLA (P=0.2), but a median 30% decrease in EJ-MSHQ score was observed after TURP (P=0.01).​​

Although the systematic review by Pires et al. (2025) suggested that TPLA may improve LUTS, Qmax, PVR, and prostate volume, confidence in these findings is limited by the substantial heterogeneity among studies, predominance of small single-arm observational cohorts, limited randomized comparative evidence, short follow-up durations, and uncertainty regarding long-term durability and comparative effectiveness relative to established BPH treatments. Consequently, the available evidence remains insufficient to determine whether TPLA improves net health outcomes compared with existing standard therapies.​

Currently, support for TPLA includes preliminary evidence. Additional high-powered, high-quality, and well-designed studies evaluating functional outcomes with longer follow-up are needed. There is currently insufficient evidence to support the use of TPLA for the treatment of urinary outlet obstruction due to BPH.

Temporarily Implanted Nitinol Device (iTind)
 
In April 2019, the FDA granted the iTind System a de novo 510(k) classification. The device is temporarily implanted into the obstructed prostatic urethra to facilitate tissue reshaping and improve urine outflow. The implant is typically removed after 5 to 7 days of treatment.


The evidence analyzing relevant clinical outcomes, such as Qmax, PVR urine, IPSS, IPSS-Quality of Life (IPSS-QoL), and sexual function (measured by the Sexual Health Inventory for Men [SHIM] and/or IIEF) includes meta-analyses, systematic reviews, prospective, multicenter, single-arm studies, and RCTs.


Franco et al.'s 2021 network meta-analysis suggests that iTind may improve LUTS; however, the improvements may be inferior to other minimally invasive and surgical options (e.g., TURP, Urolift, Rezūm, PAE, or TUMT). Systematic reviews included only one to three of the relevant single-arm or RCT studies. One systematic review by Manfredi et al. (2021) reported that aquablation had a statistically significantly lower IPSS compared with iTind and other minimally invasive surgical treatments.


A recently published follow-up study by Amparore et al. (2023) to their 2021 single-arm study reports statistically significant durable reduction in IPSS and IPSS-QoL beyond 48 months among 41 men with BPH-related LUTS and statistically significantly improved Qmax and PVR urine at 36 months among 48 men using an intention-to-treat (ITT) analysis. Qmax and PVR were not measured beyond 48 months due to the COVID-19 pandemic; consequently, the durability of the clinical outcomes was not assessed. The surgical retreatment rate for the full study cohort (N=81) from baseline up to 79 months was 11.1%, which, according to the literature, is higher than the reported retreatment rates for other minimally invasive surgical treatments. A limitation is that only about 51% of the study population was available for the more than 48-month follow-up, which may skew the interpretation of the data.

 
A 2021 multicenter, single-blinded RCT published by Chughtai et al. compared iTind to sham (N=118 vs. N=57). Participants were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, and PVR urine. In the ITT analysis at 3-month follow-up, the change in mean IPSS was not statistically significantly different for iTind and sham (−9±8.5 vs. −6.6 ± 9.5; P=0.063). There was also no statistically significant difference in IPSS-QOL, Qmax, SHIM, and IIEF scores between the groups; however, a significantly higher proportion of individuals treated with iTind achieved the primary endpoint—a reduction of at least three points on the IPSS scale—compared to sham at 3 months (78.6% vs. 60%; P=0.029). Twenty-three percent of participants were lost to follow-up or nonadherent to the original protocol, which may skew the results and interpretation of the data. At 12 months, the iTind group reported a 9.25-point decrease in IPSS (P<0.0001), a 3.52 mL/s increase in peak urinary flow rate (P<0.0001), and a 1.9-point reduction in quality of life (P<0.0001) using a per protocol (PP) analysis (a less statistically rigorous analysis). The baseline IPSS score for all participants was 22.3 ± 6.6, which translates to the moderate to severe IPSS categories.


Researchers often adopt a greater than or equal to three-point reduction in IPSS as a minimum clinically important difference (MCID); however, Rees (2015) writes that for individuals with mild LUTS, a reduction of three points can represent a significant improvement in symptoms, while in individuals with more severe LUTS, a greater than or equal to three-point reduction in IPSS may not represent a significant improvement. Instead, a greater than or equal to 25% reduction in IPSS may be a better threshold for MCID, especially for those with severe IPSS.


Another RCT by Elterman et al. (2023) found no difference in sexual or ejaculatory function between iTind and sham controlling for age, prostate volume, and baseline sexual function.


Dimitri et al. (2025) published a retrospective cohort study of 120 individuals who had symptomatic BPH and were unresponsive to alpha-blockers who were treated with iTind. At enrollment, mean (standard deviation [SD]) age was 52.9 (7.9) years with mean (SD) prostate volume of 40.3 (11.25) mL. Mean (SD) Qmax and PVR were 7.6 (2.6) mL/sec and 72.3 (35.2) mL, respectively. The reported mean (SD) IPSS-QoL was 6 (2.5) and a mean urinary symptom IPSS of 21.5 (5.1). By 3 months of follow-up, IPSS, IPSS-QoL, PVR, and Qmax were significantly improved compared to baseline and improvements continued to 12 months. No participants reported ejaculatory or sexual dysfunction at final follow-up.​


The above studies report inconsistent findings in regarding the efficacy of iTind. Studies with sufficient follow-up demonstrating durability of improved functional outcomes with comparisons to established clinical alternatives are needed. The evidence is insufficient to determine whether the technology results in an improvement in net health outcomes.


Permanently Implanted Prostatic Stent Devices


ProVee System​


Kaplan et al (2026) published the 12-month results of the ProVIDE trial (NCT05186740), a prospective, multicenter, double-blind, sham-controlled RCT of the ProVee System at 17 sites in the United States, Ireland, and Canada. A total of 221 participants were enrolled (150 ProVee, 71 sham; 2:1 randomization). Both co-primary effectiveness endpoints were met: mean IPSS improvement was 9.5 in the ProVee arm versus 5.6 for sham at 3 months (difference, −5.0; 95% CI, −7.3 to −2.7; P=0.001), and mean percent IPSS improvement from baseline was 37.8% at 12 months (P=0.002). The 30% or greater IPSS responder rate at 12 months was 61%. Mean Qmax improved from 8.8 to 14.2 mL/s at 12 months (+5.4 mL/s). No device- or procedure-related serious adverse events (SAEs) were reported through 12 months; sexual function was preserved (IIEF-5 and MSHQ-EjD stable). Six participants (4.0%) had the device removed, with no removal-related AEs. The sham arm showed clinically meaningful improvement (4.5 IPSS points at 3 months, exceeding the 3-point MCID), suggesting a substantial procedural or placebo effect that narrows the incremental benefit attributable to the device itself. After unblinding at 3 months, 90% of sham participants elected crossover; 5-year follow-up is ongoing. This is a sham control trial only, there was no active comparator–sham-controlled design is appropriate for efficacy assessment, but comparative effectiveness against established treatments is unknown. Note that the sham arm showed clinically meaningful improvement (4.5 IPSS points at 3 months, exceeding the 3-point MCID), suggesting a substantial procedural or placebo effect that narrows the incremental benefit attributable to the device​.


A ProVIDE II bridging study (N=40, 8 sites, US and Ireland) evaluated the Generation II Delivery System at 3 months (NCT06236802). Technical success was 100% (40/40 deployments). Mean IPSS improvement was 46% from baseline at 3 months; Qmax improved from 8.1 to 15.3 mL/s (+87%). No device- or procedure-related SAEs or device removals were reported.


A first-in-man study (PROVE; N=10, single-center, Australia) demonstrated 100% technical success, no device- or procedure-related SAEs through 24 months, and 40% improvement in Qmax at 24 months.


​Zenflow Spring System


The Zenflow Spring System is a small, spring-like, nitinol coil that is inserted into the urethra via cystourethroscopy to prop it open and improve urinary flow. The spring is designed to be permanent, but it can be removed.


The evidence for Zenflow includes three abstracts presented at AUA-moderated poster sessions and published as abstracts in the Journal of Urology as supplements (Elterman et al., 2023; Gilling et al., 2024a; Gilling et al., 2024b). The full manuscripts were not published in the AUA peer-reviewed journal. Elterman et al. (2023) reported results from The Zenflow Spring System Safety and Performance Study (ZEST-CAN; NCT04309695), a prospective single-arm study including 10 participants. Symptom improvement was measured utilizing the IPSS and IPSS-QOL, and functional improvement was measured by peak urinary flow rate (Qmax). Erectile and ejaculatory function were evaluated utilizing validated questionnaires. The Zenflow Spring showed a significant reduction in IPSS from baseline to 12 months (21.2 vs 11.4; P<0.01), representing a 47% reduction in IPSS. IPSS-QOL significantly improved from baseline to 12 months (5.4 vs 2.4; P<0.010) representing a 56% improvement. Qmax improved from 9.7 mL/sec at baseline to 14.0 mL/sec after treatment (P<0.05).


Gilling et al. (2024a) also published a study generated from the ZEST-CAN study They reported that 72 participants 24 months after receiving Zenflow Spring experienced a significant reduction in IPSS from baseline to 24 months (22.0 to 11.4), representing a 48% improvement in IPSS. IPSS-QOL significantly reduced from baseline to 24 months (4.5 vs 1.85) representing a 59% improvement. Qmax increased from 10.5 mL/sec at baseline to 14.0 mL/sec at 24 months, representing a 33% improvement. Another 24-month follow-up by Gilling et al. (2024b) reported erectile and ejaculatory function outcomes using the SHIM and MSHQ-EjD, respectively: no deterioration in erectile or ejaculatory function was seen through 24 months postimplantation. Other than IPSS, the reported outcomes were not established as primary endpoints; thus, caution should be taken interpreting the results. Well-powered, well-designed comparative studies that appropriately measure relevant clinical outcomes are needed.​


The BREEZE trial (NCT04987138) was a prospective, multicenter, single-blind (participant), sham-controlled RCT of the Zenflow Spring Implant at 28 sites in the US and Canada (N=205 randomized; 137 Spring, 68 sham; 2:1 randomization). Data were sourced from the US Food and Drug Administration (FDA) Summary of Safety and Effectiveness Data (SSED) (P250007); no peer-reviewed publication was available at the time of this review. ​In the intent-to-treat (ITT) population, the co-primary efficacy endpoints failed to reach statistical significance: the 30% or greater IPSS responder rate was 51.8% versus 39.7% for sham at 3 months (P=0.102), and the mean percent IPSS change was −32.1% at 12 months (P=0.231). Post hoc, 38 participants (18.5% of the randomized population) were retrospectively excluded for erroneous enrollment due to obstructive median lobe anatomy; in the modified ITT/intended use (mITT/IU) population, the responder rate was 59.6% versus 33.3% and mean percent IPSS change was −37.2% at 12 months. Mean Qmax improved modestly (+1.8 mL/s ITT at 12 months). No device- or procedure-related SAEs were reported; the most common procedure-related AEs were painful ejaculation (4.4%) and dysuria (3.6%). Sexual function was preserved (SHIM and MSHQ-EjD stable). Through 24 months, 18 of 137 implants (13.1%) were removed, with no removal-related AEs. The primary analysis population (mITT/IU) was defined post hoc after the pre-specified ITT analysis failed to meet co-primary endpoints, which could introduce selection bias. An independent retrospective review confirmed enrollment errors among the excluded subjects. After unblinding at 3 months, 88% of sham participants elected crossover; 5-year follow-up is ongoing.​


​The Spanner™ Temporary Prostatic Stent


Dineen et al. (2008) compared the outcomes of Spanner placement (n=100) and standard of care (n=86) after TUMT and 3 to 10 days of catheterization. After catheterization, the standard of care group received no further treatment until follow-up visits. The primary outcomes were IPSS voiding subscore, IPSS irritative subscore, voiding diary data, and Benign Prostatic Hyperplasia Impact Index. IPSS voiding and irritative subscores were statistically significantly improved at 1 week post-Spanner placement, but not at weeks 2, 4, 5, and 8. Individuals in the Spanner group reported improved Benign Prostatic Hyperplasia Impact Index scores during the first 2 weeks of Spanner stent use, but this trend was no longer significant beyond the first 2 weeks. Limitations of this paper include no record of the loss to follow-up or missing data. The results demonstrate that benefit of Spanner compared to standard care is not durable. 

In a 2007 observational study, 43 participants received the Spanner prostatic stent, which was removed and replaced every 3 months if it was tolerated. The authors reported that 63% of the participants experienced an unsatisfactory outcome such as immediate or delayed retention or elective removal because of unbearable symptoms. Only 21% of the participants continued to have a stent in situ by the end of the study.

Goh et al. (2013) reported their experiences with the Spanner prostatic stent in 14 participants. Of the 14 participants, the four participants from the Brighton center all experienced adverse events. The first returned the 1-day post-stenting with retention where it was revealed that the stent was occluded by a blood clot. Two other participants developed severe LUTS, which required removal on day 10, and one of the two had migration of the stent into the bladder. The fourth complained of slow stream, severe LUTS day 7, and subsequently went into retention 3 days later. Of the 12 participants from Bristol, seven received Spanner, and among the seven, four stents failed. Several participants returned within 2 to 14 days with retention post-stenting, and one participant experienced the Spanner pushing into the bladder. This study does not increase the confidence that the Spanner prostatic stent is efficacious, as the majority of implanted stents failed. Additionally, functional outcomes were not analyzed in this study.

In a prospective 2022 study by Cambio et al., the Spanner prostatic stent was placed for three cycles of 30 days in catheter-dependent men with comorbid conditions, confirmed detrusor contractility, and catheter-associated discomfort. Primary endpoint was the proportion of individuals who achieved and maintained adequate bladder drainage over 90 days, defined as a PVR of less than or equal to 150 mL. Of the 107 men enrolled, 25 men (23%) discontinued the study; 79 of the 107 [73.8%; 95% CI, 0.644–0.819], P<0.0001) enrolled men met the primary study endpoint, demonstrating adequate bladder drainage of PVR less than or equal to 150 mL during 3 months of sequential use (ITT). Expert consensus maintains that a PVR less than or equal to 100 is considered normal, but a PVR less than or equal to 200 may be acceptable among adults and elderly. A PVR of less than or equal to 150 mL represents an appropriate endpoint for this population. Ten participants entered the Continued Access Protocol (CAP) on completion of the three cycles and had the Spanner replaced approximately every 30 days. Within the first 8 months, five participants had a PVR between 151 and 250 mL and two others had PVR greater than 250 mL. Fourteen percent of all participants (15/107) reported severe adverse events during the study, and most AEs were mild (151/173; 87.3%) to moderate (20/173; 11.6%) in severity.

In conclusion, the evidence is inconsistent to establish that the Spanner prostatic stent effectively relieves the LUTS caused by BPH. Studies with longer follow-up demonstrating improvements in functional outcomes are needed. Although the FDA determined that the Spanner prostatic stent is safe, the literature presents notable challenges associated with Spanner. The Spanner’s durability and efficaciousness are not supported by the current literature.

Drug-coated Balloon BPH Catheter System​ (e.g., ​Optilume®) ​

The Optilume® BPH Catheter System is the first prostatic drug-coated balloon dilation system for the treatment of obstructive BPH. The system combines mechanical dilation to achieve commissurotomy of the anterior prostatic urethra to open the urethral lumen, with the delivery of the drug paclitaxel to the dilated area to maintain urethral patency. Paclitaxel is an antiproliferative drug that has been extensively used in vascular devices to prevent restenosis after balloon angioplasty or stenting [6]. The goal of this technology is to provide immediate symptomatic relief via balloon dilation and to achieve durable results via localized paclitaxel delivery.


The data from the pivotal clinical trial PINNACLE (A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia) were the basis for the PMA approval decision; prior to this trial, the EVEREST-I (Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter) trial, a single-arm, prospective, multicenter, nonrandomized study, investigated the safety and effectiveness of Optilume for treatment of BPH. The best available literature associated with these trials is discussed here.


Kaplan et al. (2021) reported 1-year outcomes of the EVEREST-I study evaluating the safety and efficacy of the Optilume® BPH Catheter System. Participants were men more than 50 years old with moderate-to-severe LUTS secondary to BPH, peak urinary flow rate of 5 to 15 mL/s, prostatic urethra length 30 to 55 mm, and prostate volume 20 to 80 g. Primary endpoints included the following:

  • Therapeutic responder at 3 months measured by the proportion of subjects experiencing at least a 40% improvement in IPSS scores from baseline to 3 months
  • Major device/procedure-related complications measured by the proportion of subjects reporting a composite of device/procedure-related severe urinary retention (lasting >14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion.

Other functional outcomes such as Qmax, PVR, and IPSS-QOL were measured in this study, but they were not analyzed as primary endpoints. Ninety-four percent of the men who received Optilume completed their 1-year follow-up. The percentage of subjects with an improvement greater than or equal to 40% in IPSS from baseline was 81% at 3 months and 1 year. The average IPSS improved from 22.3 at baseline to 7.9 at 1 year. This is a clinically meaningful change given that, for those with severe IPSS (defined by an IPSS score of 20–35), a greater than or equal to 25% reduction in IPSS score is clinically significant.


The most frequent treatment-related AEs were postprocedural hematuria (15.0%), postoperative urinary retention (13.8%), urinary incontinence (13.8%), urinary tract infection (8.8%), ejaculation disorder (8.8%), and dysuria (7.5%). Large-diameter balloons were associated with poorer safety profile, namely, higher rates of bleeding and incontinence-related events that resulted in this balloon diameter being removed as a size option for the last 31 subjects in the study.


The 2-year follow-up paper to the EVEREST-I trial by Pichardo et al. (2023) reported IPSS improvement of 22.3 at baseline to 8.2—a 62% reduction in IPSS (P<0.001). The authors found an improvement in secondary outcomes, Qmax and PVR, but the statistical​ significance was not reported from baseline to 2 years.​ The analysis of additional functional outcomes as primary endpoints and the addition of controlled trials would support the efficacy of Optilume. Additionally, studies demonstrating durability of treatment (longer follow-up) are needed.


Kaplan et al. (2023a) conducted prospective, multicenter, double-blind, 2:1 randomized, sham-controlled, crossover clinical study. Primary endpoints included:

  • IPSS measured by change from baseline to 3 months in the sham arm compared to the change from baseline to 12 months in the Optilume BPH arm
  • Major device-related serious complications measured by the proportion of participants with several clinical complications

Primary endpoints were analyzed with an ITT analysis. A total of 148 participants were randomly assigned to receive Optilume BPH (n=100) or sham (n=48). Sham treatment consisted of rigid cystoscopy followed by insertion of a sheathed (21F) Optilume catheter that was not inflated.


Participants randomly assigned to receive Optilume BPH saw a reduction in IPSS of 11.5 ± 7.8 points at 1 year posttreatment, as compared to a reduction of 8.0 ± 8.3 points at 3 months in the sham arm (diff = 3.4; P=0.008). The endpoint incorporated a super-superiority margin of 25% for the sham effect at 3 months. Incorporating the 25% super-superiority margin, the imputed difference between arms was 1.4 (P=0.178). The improvement in IPSS for the Optilume BPH arm at 12 months did not reach statistical significance, with a 25% super-superiority margin when compared to the improvement in the sham arm at 3 months.


A super-superiority margin is a more rigorous analysis employed to discern that an observed difference between groups is not only statistically significant but also clinically meaningful. It reduces the risk of drawing false conclusions from study results, ensures that the observed difference is not due to change or measurement error, and accounts for unexpected variations in the data. A super-superiority margin increases the confidence one can have in the study findings and strengthens validity of conclusions drawn from the data.


Additionally, no participants experienced an event qualifying for the predefined composite of serious device-related complications through 12 months. Eighteen serious adverse events were recorded among 111 participants; five events were classified as related to the study device: four postprocedure hematuria events that resolved without sequelae and one urethral false passage requiring extended catheterization.


Responder rate at 3 months was analyzed as a secondary endpoint. A responder was defined as a participant with IPSS improvement of greater than or equal to 30% from baseline. IPSS improved an average of 49% (95% CI, 42.7%–55.4%) from baseline to 1 year in the Optilume arm, which met the performance goal of 30%.​


The analytical rigor is appreciated in this study. LUTS appear to be significantly improved by Optilume at 12 months compared to sham at 3 months, indicating a durable treatment effect; however, this difference is absent when a 25% super-superiority margin is applied. Thus, this trial failed to meet its primary efficacy endpoint.


Kaplan et al. (2023b) presented 2-year follow-up data for Optilume. The 48 sham participants were followed for 1 year and then discontinued from the study unless they opted to cross over to treatment with Optilume BPH. Of the 100 participants randomly assigned to receive Optilume, data for 77 participants are available for 2-year follow-up. Participants who received treatment with the Optilume BPH Catheter System demonstrated a 50.8% improvement in IPSS from baseline to the 2-year follow-up. IPSS decreased from 23.4 ± 5.5 (n=100) at baseline to 11.0 ± 7.0 (n=74) at 2 years. A total of 67.5% (56/83 CI, 56.3–77.4) of participants who underwent treatment with Optilume were symptomatic responders as defined by greater than or equal to 30% improvement in IPSS without necessitating further medical or surgical retreatment. The denominator (n=83) encompasses the IPSS data from participants currently enrolled in the study with a completed 2-year visit in addition to those who exited due to treatment failure. Responder rate greater than or equal to 30% was analyzed as a secondary endpoint.

​

Kaplan et al. (2024) reported 4-year follow-up data for 59 participants from the EVEREST trial (NCT03423979). Data for 80 participants were analyzed in the original study. Primary data were reported from the intent-to-treat population, with no imputation for missing data. The original primary outcome measure was the proportion of subjects experiencing at least a 40% improvement in IPSS scores from baseline to 3 months, but the primary endpoints for long-term follow-up included functional assessments and symptomology. Changing a primary endpoint after data are reviewed can introduce post-hoc bias.​ The first study's sample size was based on the primary endpoint analysis at 3 months, which can introduce underpowering. A large proportion of individuals experienced a clinically meaningful improvement in IPSS score from baseline (−12.1 ± 8.5​). Qmax improved +5.6 ± 9.7 mL/s from baseline after 4 years; however, approximately a quarter of individuals experienced no change or decrease in Qmax. PVR was noted to improve an average of −5.2 ± 84.0 from baseline after 4 years, but individual outcomes were polarized, with about half of individuals experiencing an improvement and the other half experiencing no change or a worsening of PVR. These findings demonstrate that Optilume may deliver durable symptom improvement, but the individual-level outcomes remain highly variable. Additionally, comparative trials are needed.


Copelan et al. (2025) compared sexual function outcomes based on the assessments ​IIEF-EF and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) between individuals who received Optilume or a sham surgical procedure. IIEF-EF and MSHQ-EjD scores in the Optilume BPH group were not different from the sham group at 3, 6, or 12 months. 


Although the Optilume® BPH Catheter System has demonstrated improvements in lower urinary tract symptoms and acceptable preservation of sexual function in early studies, the overall evidence remains insufficient to establish the technology as an effective standard treatment for BPH. The available data are largely driven by symptom-based outcomes, while objective measures of urinary function such as Qmax and PVR have been inconsistently reported and have shown considerable variability among individual patients. Importantly, the pivotal randomized sham-controlled PINNACLE trial failed to meet its prespecified primary efficacy endpoint when the predefined 25% super-superiority margin was applied, creating uncertainty regarding the clinical significance of the observed treatment benefit. Long-term follow-up data suggest durability of symptom improvement in some patients, but these findings are limited by attrition, post-hoc analyses, changing endpoint definitions, and the absence of contemporary comparative trials. While the safety profile appears generally favorable, additional adequately powered RCTs with robust assessment of objective functional outcomes and long-term durability are needed. Therefore, current evidence is insufficient to determine that Optilume improves net health outcomes, and the device is considered investigational/experimental for the treatment of BPH.​

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Rees J. Patients not P values. BJU Int. 2015;115(5):678-679. 

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. 2013;190(6):2161-2167.

Ruszat R, Wyler SF, Seitz M, et al. Comparison of potassium-titanyl-phosphate laser vaporization of the prostate and transurethral resection of the prostate: update of a prospective non-randomized two-centre study. BJU Int. 2008;102(10):1432-1439.


Sandhu JS, Bixler BR, Dahm P, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. 2024;211(1):11-19. 

Schorsch I, Muschter R, Danielli L, et al. Two year follow-up of a multi-center clinical study using water-induced thermotherapy for BPH. Paper presented at the American Urological Association Annual Meeting; May 2, 2000; Atlanta, GA.

 

Sciacqua LV, Vanzulli A, Di Meo R, et al. Minimally Invasive Treatment in Benign Prostatic Hyperplasia (BPH). Technol Cancer Res Treat. 2023;22:15330338231155000. 

Sessa F, Polverino P, Siena G, et al. Transperineal Laser Ablation of the Prostate (TPLA) for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction. J Clin Med. 2023;12(3):793. 

Sønksen J, Barber NJ, Speakman NJ, et al. Prospective randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH-6 study. Eur Urol. 2015;68(4):643-652. 

Sotelo R, Clavigo R, Carmona O, et al. Robotic simple prostatectomy. J Urol. 2008;179:513-515.


Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial | ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04781049?tab=results.


US Food and Drug Administration (FDA). Rezum System. 510(k) Summary [FDA website] 09/12/16. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150786.pdf. Accessed June 23, 2026.


US Food and Drug Administration (FDA).​ Summary of Safety and Effectiveness Data (SSED). ProVee System for BPH. https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250011B.pdf. Accessed June 23, 2026.

US Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED). Zenflow Spring Implant and Delivery System. https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250007B.pdf. June 23, 2026.​

US Food and Drug Administration (FDA). AQUABEAM® Robotic System. Approval Letter. [FDA website] 03/11/2021. Available at: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170024.pdf. Accessed June 23, 2026.

 

US Food and Drug Administration (FDA). AQUABEAM® Robotic System. 510(k) Summary [FDA website] 03/11/2021. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202961.pdf. Accessed June 23, 2026.

 

US Food and Drug Administration (FDA). Premarket approval (PMA). 10/07/2022. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060010S013. Accessed June 23, 2026.

 

US Food and Drug Administration (FDA). UroLift® Advanced Tissue Control (ATC®) System. 510(k) Summary [FDA website] 06/05/2020. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200441.pdf. Accessed June 9, 2026.

US Food and Drug Administration (FDA). UroLift® 2 ATC Advanced Tissue Control System. 510(k) Summary [FDA website] 09/22/2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232558.pdf. Accessed June 9, 2026.

 

Viitala A, Anttinen M, Mäkelä P, et al. Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic obstruction: 1-year clinical outcomes of a phase II study. BJU Int. 2025;136(3):473-483. 


Viitala A, Anttinen M, Wright C, et al. Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12-month clinical outcomes of a phase I study. BJU Int. 2022;129(2):208-216. 


Wang XY, Zong HT, Zhang Y. Efficacy and safety of prostate artery embolization on lower urinary tract symptoms related to benign prostatic hyperplasia: a systematic review and meta-analysis. Clin Interv Aging. 2016;11:1609-1622.


Xiang P, Guan D, Du Z, et al. Efficacy and safety of prostatic artery embolization for benign prostatic hyperplasia: a systematic review and meta-analysis of randomized controlled trials. Eur Radiol. 2021;31(7):4929-4946. 

Zhou G, He J, Huang G, et al. Efficacy and Safety of Transurethral Columnar Balloon Dilation of the Prostate for the Treatment of Benign Prostatic Hyperplasia: A Multicenter Trial. Comput Math Methods Med. 2022;2022:7881247. 


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Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY​

52441

52442

52450

52597

52601

52630

53850

53854

55801

55821

55831

55867
​
THE FOLLOWING CODE IS USED TO REPRESENT HOLMIUM LASER ABLATION OF THE PROSTATE (HoLAP), PHOTOSELECTIVE VAPORIZATION (PVP), and TRANSURETHRAL ELECTROVAPORIZATION OF THE PROSTATE (TUVP):

52648

THE FOLLOWING CODE IS USED TO REPRESENT HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HoLEP) and HOLMIUM LASER RESECTION OF THE PROSTATE (HoLRP):

52649

NOT MEDICALLY NECESSARY

THE FOLLOWING CODES ARE USED TO REPRESENT TRANSURETHRAL ULTRASOUND-GUIDED LASER-INDUCED PROSTATECTOMY (TULIP):

52648

52649

THE FOLLOWING CODE IS USED TO REPRESENT VISUAL LASER ABLATION OF THE PROSTATE (VLAP) AND INTERSTITIAL LASER COAGULATION (ILC):

53899​

THE FOLLOWING CODE IS USED TO REPRESENT WATER-INDUCED THERMOTHERAPY (WIT) OF THE PROSTATE:

53899

THE FOLLOWING CODE IS USED TO REPRESENT Transurethral needle ablation​​ (TUNA):

53852

EXPERIMENTAL/INVESTIGATIONAL​

0714T​

0867T

0941T

0942T

0943T

0950T

51721

52282

52443

53855

53865

53866

55881

55882

THE FOLLOWING CODE IS USED TO REPRESENT TRANSURETHRAL BALLOON DILATION OF THE PROSTATE:

53899

THE FOLLOWING CODE IS USED TO REPRESENT TRANSURETHRAL ETHANOL ABLATION OF THE PROSTATE (TEAP):

53899

THE FOLLOWING CODE IS USED TO REPRESENT PROSTATE ARTERY EMBOLIZATION (PAE):

37242​​
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
​​N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms
HCPCS Level II Code Number(s)
​C2596 Probe, image-guided, robotic, waterjet ablation
​
C9739 Cystourethroscopy, with insertion of transprostatic implant; 1 to 3 implants

C9740 Cystourethroscopy, with insertion of transprostatic implant; 4 or more implants​
Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

Revisions From ​MA11.004r:
09/21/2026
​This version of the policy will become effective 09/21/2026.


This policy has been updated to include permanent nitinol urethral expansion device, ​ProVee System, as Experimental/Investigational.

CPT code 52282 ​was added as experimental/investigational.

Revisions From ​MA11.004q​:
01/01/2026

Inclusion of a policy in a Code Update memo does not imply that a full review of 
the policy was completed at this time.​

This policy has been identified for the CPT code update, effective 01/01/2026.

The following codes have been added to this policy as experimental/investigational:
  • 52443
The following codes have been added to this policy as medically necessary:
  • 52597
The following code has been added to this policy as not medically necessary:
  • 53899​
​T​he following codes have been deleted from this policy:
  • ​52647
  • 0421T
  • 0619T

Revisions From​ ​MA11.004p:​
07/28/2025​​

This version of the policy will become effective 07/28/2​025​.

The policy criteria for water-jet hydrosection (Aquablation) was updated to remove the following requirements to align with Medicare's LCD on 

Transurethral Waterjet Ablation of the Prostate​:
  • The individual is age 80 years or younger
  • Prostate volume is measured by transrectal ultrasound (TRUS)​​
  • A voided volume that is greater than 125 cc​
The CPT code 55801 was added as medically necessary and the CPT code 37242 has been added as experimental/investigational to replace the code 53899 that was representing prostate artery embolization (PAE).​​

The title of this policy was changed to from: Minimally Invasive Treatments for Urinary Outlet Obstruction due to Benign Prostatic Hyperplasia (BPH)​ to: Surgical and Minimally Invasive Treatments for Urinary Outlet Obstruction due to Benign Prostatic Hyper​plasia (BPH).​

Revisions From​ ​11.17.06o​:​
07/01/2025

Inclusion of a policy in a Code Update memo does not imply that a full review of the policy was completed at this time.


This policy has been identified for the CPT code update, effective 07/01/2025.

The following CPT code has been added to this policy:
  • 0950T​
The following CPT code has been removed from this policy:
  • 53899​

Revisions From​ ​MA11.004n:​
03/24/2025​​

This version of the policy will become effective 03/24/2025​.

This policy was updated to communicate that the following procedures are considered experimental/investigational:

  • Transurethral ultrasound ablation (TULSA)​​
  • Permanent nitinol urethral expansion device (e.g., Zenflow Spring System)

The following CPT codes have been added to this policy:

51721, 55881, 55882, 0941T, 0942T, 0943T​


Revisions From​ ​MA11.004m​:​
01/01/2025​
​​Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

This policy has been identified for the CPT code update, effective 01/01/2025.

The following CPT codes have been added to this policy:
​53865, 53866

The following HCPCS code has been removed from this policy:
C9769​​

Revisions From​ ​MA11.004l​:​
07/01/2024
This version of the policy will be issued on 08/12/2024.  It is retroactively effective to 07/01/2024.​

This policy was updated to communicate that: 

The following are considered experimental/investigational:
  • Temporarily implanted nitinol device (iTind) 
  • Spanner™ ​temporary prostatic stent
  • Drug-coated balloon​ catheter system (e.g., ​Optilume®) 
  • Transperineal laser ablation (TPLA).​
​CPT code 0867T was added as experimental/investigational.​

The narrative for CPT code 0714T was revised.

This policy was identified for the CPT code update, effective 07/01/2024.​​​

​Revisions From​ MA11.004k:​
01/01/2024Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​
​11/01/2023
​This policy has been reissued in accordance with the Company's annual review process.
​11/21/2022
​This version of the policy will become effective 11/21/2022.

This policy was updated to communicate:

  • Coverage for water vapor thermotherapy (Rezūm) and the applicable code (53854) has changed from experimental/investigation to medically necessary when specific criteria are met within the policy
  • Incorporate updated criteria for Prostatic Lift procedure (UroLift)

Revisions From​ MA11.004j:
07/01/2022This policy has been identified for the HCPCS code update, effective 07/01/2022.
The following CPT code has been added to this policy: 0714T (Experimental/Investigational)

 Revisions From MA11.004i:
12/27/2020
(Posted 
12/06/2021)		This version of the policy has a retro-effective date of 12/27/2020.

The policy has been updated to mirror Medicare's change in coverage position for the Transurethral waterjet ablation procedure for individuals with BPH. The coverage position for this procedure has been changed to "Medically Necessary" and medical necessity criteria for the procedure have also been added to the policy section.​

Revisions From MA11.004h:
01/01/2021This version of the policy will become effective 01/01/2021.
The following HCPCS code has been deleted from the policy: C9747 
(Experimental/Investigational)

Revisions From MA11.004g:
01/01/2020This version of the policy will become effective 01/01/2020.
The following HCPCS code has been added to the policy: C2596 (Experimental/Investigational)

Revisions From MA11.004f:
12/02/2019This version of the policy will become effective 12/02/2019.

This policy was updated to:
  • Incorporate the Company's experimental/investigational position of transurethral destruction of prostate tissue by radiofrequency generated water vapor thermotherapy (Rezū​m)
  • Include the Company's experimental/investigational position of prostate artery embolization
  • Addition of simple prostatectomy and transurethral incision of the prostate (TUIP) to policy language as medically necessary
  • Deletion of Transurethral needle ablation (TUNA) from the policy as medically necessary. This procedure is no longer recommended per American Urological Association (AUA) guidelines for the treatment of lower urinary tract symptoms (LUTS) attributed to BPH.
  • Coverage of medically necessary procedures will be for individuals 45 years or older with a diagnosis of lower urinary tract symptoms secondary to benign prostatic hypertrophy.
  • Remove the clause regarding PSA level under Prostatic Lift procedure.
The following CPT codes have been added to the policy: 37243, 52450, 53854, 55821, 55831

The following ICD-10 diagnosis codes have been deleted from the policy: C61 and Z85.46.

Revisions From MA11.004e:
11/22/2017This policy has been reissued in accordance with the Company's annual review process.
07/01/2017This policy has been identified for the HCPCS code update, effective 07/01/2017.

The following HCPCS code has been added to this policy.

C9747 Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance

Revisions From MA11.004d:
10/01/2016This policy has been identified for the ICD-10 code update, effective 10/01/2016.

Revised policy MA11.004d was issued as a result of the ICD-10 Coding update for 10/01/2016 . This update does not imply a full review of the policy was completed at this time. The following coding changes were made:

The following ICD-10 code has been revised
From: N40.1 Enlarged Prostate with lower urinary tract symptoms
To:N40.1 Benign prostatic hyperplasia with lower urinary tract

Revisions From MA11.004c:
04/13/2016This version of the policy will become effective 04/13/2016.

The following HCPCS code representing transurethral waterjet ablation of prostate tissue has been added to the policy: 0421T

Revisions From MA11.004b:
08/26/2016 (posted 12/30/2015)This version of the policy has a retro-effective date of 08/26/2015.

The policy has been updated to mirror Medicare's change in coverage position for the Prostatic Urethral Lift (UroLift) procedure for individuals with BPH. The coverage position for this procedure has been changed to "Medically Necessary" and medical necessity criteria for the procedure have also been added to the policy section.

Revisions From MA11.004a:
04/08/2015This version of the policy will become effective 04/08/2015.

The policy was updated to communicate the company's coverage position and criteria for the Prostatic Urethral Lift (UroLift) for the treatment of individuals with lower urinary tract symptoms (LUTS) secondary to Benign Prostatic Hyperplasia (BPH).

Revisions From MA11.004:
01/01/2015This is a new policy.

9/21/2026
9/21/2026
MA11.004
Medical Policy Bulletin
Medicare Advantage
No
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