Policy title: Transurethral Water Vapor Thermal Therapy for Benign Prostatic Hypertrophy

Policy number: MA 4.053

Effective date: 10/1/2026

Policy

Transurethral water vapor thermal therapy is considered investigational as a treatment of benign prostatic hyperplasia. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

This medical policy applies to Medicare Advantage plans offered by Capital Blue Cross and its subsidiaries.

Cross-References

• MA 1.147 Prostatic Urethral Lift
• MA 1.164 Temporarily Implanted Nitinol Device (iTind) for Benign Prostatic Hyperplasia
• MA 4.043 Focal Treatments for Prostate Cancer
• MA 4.054 Hydrogel Spacer Use During Radiotherapy for Prostate Cancer
• MA 5.035 Magnetic Resonance–Guided Focused Ultrasound

Description/Background

Benign prostatic hyperplasia (BPH) is a common condition in older men, affecting to some degree 40% of men in their 50s, 70% of those between ages 60 and 69, and almost 80% of those ages 70 years and older. Benign prostatic hyperplasia is a histologic diagnosis defined as an increase in the total number of stromal and glandular epithelial cells within the transition zone of the prostate gland. In some men, BPH results in prostate enlargement which can, in turn, lead to benign prostate obstruction and bladder outlet obstruction, which are often associated with lower urinary tract symptoms (LUTS) including urinary frequency, urgency, irregular flow, weak stream, straining, and waking up at night to urinate. Lower urinary tract symptoms are the most commonly presenting urological complaint and can have a significant impact on quality of life.

Benign prostatic hyperplasia does not necessarily require treatment. The decision on whether to treat BPH is based on an assessment of the impact of symptoms on quality of life along with the potential side effects of treatment. Options for medical treatment include alpha-1-adrenergic antagonists, 5-alpha-reductase inhibitors, anticholinergic agents, and phosphodiesterase-5 inhibitors. Medications may be used as monotherapy or in combination.

Patients with persistent symptoms despite medical treatment may be considered for surgical treatment. The traditional standard treatment for BPH is transurethral resection of the prostate (TURP). Transurethral resection of the prostate is generally considered the reference standard for comparisons of BPH procedures. Several minimally invasive prostate ablation procedures have also been developed, including transurethral microwave thermotherapy, transurethral needle ablation of the prostate, urethromicroablation phototherapy, and photoselective vaporization of the prostate. The prostatic urethral lift procedure involves the insertion of 1 or more permanent implants into the prostate, which retracts prostatic tissue and maintains an expanded urethral lumen.

Transurethral water vapor thermal therapy and aquablation have been investigated as minimally invasive alternatives to TURP. Transurethral water vapor thermal therapy uses radiofrequency-generated water vapor (~103°C) thermal energy based on the thermodynamic properties of convective versus conductive heat transfer to ablate prostate tissue. Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra.

Regulatory Status

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

In April 2017, the Aquabeam^® System (Procept Robotics Corporation) was cleared for marketing by the FDA through the 513(f)(2) (de novo) classification process (DEN170024). The device is intended for the resection and removal of prostate tissue in males with LUTS due to BPH, based on WATER trial.

Rationale

Summary of Evidence

For individuals who have benign prostatic hypertrophy (BPH) and lower urinary tract symptoms (LUTS) who receive transurethral water vapor thermal therapy, the evidence includes a single 3-month, sham-controlled, randomized trial of 197 patients with a 5-year uncontrolled follow-up phase and 1 multicenter, prospective, single-arm study. The outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. At 3 months, LUTS improved more in the intervention group compared to the sham procedure. No adverse effects on erectile or ejaculatory function were observed, and improvements were sustained through 5 years of follow-up. The evidence is limited by the small sample size, lack of blinding of longer-term outcomes, and lack of comparison to alternative treatments such as transurethral resection of the prostate (TURP). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

NA

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes is not exhaustive and may change from time to time as permitted by law or applicable clinical guidelines. The inclusion of a code in this section is not a guarantee of coverage or payment. In addition, not all covered services are eligible for separate reimbursement.

Investigational for Nitinol / iTind Device; therefore, not covered:

References

1. UpToDate. Epidemiology and pathophysiology of benign prostatic hyperplasia. Updated January 2025. Available at: https://www.uptodate.com/contents/epidemiology-and-pathophysiology-of-benign-prostatic-hyperplasia?search=benign%20prostatic%20hyperplasia&topicRef=6891&source=see_link. Accessed April 29, 2025.
2. Westwood J, Geraghty R, Jones P, et al. Rezum: a new transurethral water vapour therapy for benign prostatic hyperplasia. Ther Adv Urol. Nov 2018; 10(11): 327-333. PMID 30344644
3. McVary KT, Roehrborn CG. Three-Year Outcomes of the Prospective, Randomized Controlled Rezūm System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Urology. Jan 2018; 111: 1-9. PMID 29122620
4. Food and Drug Administration. Aquabeam System Device Classification Under Section 513(f)(2) (De Novo). 2017. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm?ID=DEN170024. Accessed April 29, 2025.
5. Kang TW, Jung JH, Hwang EC, et al. Convective radiofrequency water vapour thermal therapy for lower urinary tract symptoms in men with benign prostatic hyperplasia. Cochrane Database Syst Rev. Mar 25 2020; 3(3): CD013251. PMID 32212174
6. McVary KT, Gange SN, Gittelman MC, et al. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. May 2016; 195(5): 1529-1538. PMID 26614889
7. Shin BNH, Qu L, Rhee H, et al. Systematic review and network meta-analysis of re-intervention rates of new surgical interventions for benign prostatic hyperplasia. BJU Int. Aug 2024; 134(2): 155-165. PMID 38600763
8. McVary KT, Rogers T, Roehrborn CG. Rezūm Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. Apr 2019; 126: 171-179. PMID 30677455
9. Samir M, Elaal AAA, Gad KAS, et al. Two-year follow-up comparing Rezūm therapy versus bipolar transurethral resection of the prostate for treating benign prostatic hyperplasia. A prospective randomized study. Int J Urol. May 2024; 31(5): 545-550. PMID 38291876
10. McVary KT, Gittelman MC, Goldberg KA, et al. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. Sep 2021; 206(3): 715-724. PMID 33872051
11. McVary KT, El-Arabi A, Roehrborn C. Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia. Sex Med. Dec 2021; 9(6): 100454. PMID 34731779
12. Law YXT, Chen WJK, Shen L, et al. Convective Water Vapor Energy Ablation (Rezum®) Versus Prostatic Urethral Lift (Urolift®): A 2-Year Prospective Study. J Endourol. Dec 2024; 38(12): 1387-1394. PMID 39302046
13. Lim CY, Lai CC, Tsai YW. Comparison of Durability Between Rezum Water Vapor Therapy and UroLift in Treating Benign Prostatic Hyperplasia: A Multicenter Propensity Score-Matched Analysis. Cureus. Mar 2025; 17(3): e80914. PMID 40125525
14. Lerner LB, McVary KT, Barry MJ, et al. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART II-Surgical Evaluation and Treatment. J Urol. Oct 2021; 206(4): 818-826. PMID 34384236
15. 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. Jan 2024; 211(1): 11-19. PMID 37706750
16. National Institute for Health and Care Excellence. Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia. 2020. https://www.nice.org.uk/guidance/mtg49/chapter/1-Recommendations. Accessed April 29, 2025.

Policy History

• MA 1.164
• 04/01/2026 Major review; Creation of new policy. Statement removed from MA 4.043.

Plans issued by Capital Blue Cross and it’s subsidiaries are independent licensees of the Blue Cross Blue Shield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.

Health care benefit programs issued or administered by Capital Blue Cross and/or its subsidiaries, Capital Advantage Insurance Company^®, Capital Advantage Assurance Company^® and Keystone Health Plan^® Central. Independent licensees of the Blue Cross BlueShield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.