I. Disclaimer

This document is intended to be used as a reference for non-VA providers and not intended to replace clinical judgment when determining care pathways. These guidelines do not guarantee benefits or constitute medical advice.

II. Clinical Determinations and Indications

1. Indications for Transurethral Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia
2. Transurethral water vapor thermal therapy is indicated for the treatment of lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH) and may be considered medically necessary/covered when ALL the following criteria are met:
   • Age greater than or equal to 40
   • Persistent moderate to severe symptoms despite maximal medical management including ANY of the following:
     • International Prostate Symptom Score (IPSS) greater than or equal to 13
     • Maximum urinary flow rate of less than or equal to 15 mL/s (voided volume greater than 125 cc)
   • Failure, contraindication, intolerance, or Veteran refusal of at least three months of conventional medical therapy for LUTS with BPH (e.g., alpha-blocker, phosphodiesterase 5  inhibitor, finasteride/dutasteride)
   • Prostate enlargement determined by ultrasound or cystoscopy
   • Poor candidate for other surgical interventions for BPH

Note: Provider should use clinical judgment if prostate volume is greater than 80 cc

2. Limitations/Exclusions
3. Transurethral water vapor thermal therapy is not indicated if any of the following are applicable:
   • Active urinary tract infection
   • History of bacterial prostatitis in the past three months
   • Neurogenic bladder (areflexic/atonic bladder)
   • Prostate cancer
4. For all other conditions or indications not listed in section II.a. of this document, transurethral water vapor thermal therapy is considered not medically necessary and not covered due to insufficient evidence of efficacy and safety.

3. Description of Treatment
4. Transurethral water vapor thermal therapy is a minimally invasive procedure used to treat LUTS secondary to BPH. This procedure can be done in a urologist’s office, outpatient surgery center, or hospital based operating room under light sedation and local anesthesia.

• During the procedure, a urologist uses a hand-held device to pass a transurethral needle through the urethra to reach the prostate. The system delivers an injection of steam directly into the swollen prostate tissue. As the steam condenses, heat is released, leading the cells to breakdown and die. Over time, the body absorbs the treated tissue as part of the natural healing process.

• Following the procedure, patients are typically sent home with an indwelling Foley catheter for three to seven days. Relief from LUTS is typically experienced within one month of the procedure.

III. Background and Supporting Information

The following information is for reference purposes only in accordance with the medical benefits package outlined in 38 C.F.R. § 17.38 (b). Each subsection supports VA’s determinations for medical necessity and alignment with generally accepted standards of medical practice.

1. Background Information
2. The prostate is a small muscular gland within the male reproductive system that gradually enlarges as a person ages, leading to a condition known as benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia is common among individuals with prostates over 45 years of age. As the prostate becomes enlarged, it may squeeze the urethra and cause lower urinary tract symptoms (LUTS) such as increased urinary frequency, urgency, irregular flow, weak stream, straining, and nocturia. As these symptoms worsen, they can have a significant negative impact on a person’s quality of life.

Medical Management

Early diagnosis of BPH is important, as untreated BPH may lead to other medical conditions such as urinary tract infections, bladder or kidney damage, bladder stones, and incontinence.

The decision to treat BPH depends on the severity of symptoms and the potential side effects of treatment. Treatment options may include medications that relax the muscles of the prostate and bladder neck, and/or block the production of hormones that cause prostate growth. In cases where symptoms persist despite medical management or when significant side effects occur, surgical interventions may be considered.

Transurethral Water Vapor Thermal Therapy (Rezūm)

Transurethral water vapor thermal therapy is a minimally invasive alternative to the traditional surgical procedure, transurethral resection of the prostate (TURP) for BPH. The Rezūm system, approved by the Food and Drug Administration (FDA), offers flexibility in treating all prostate zones regardless of prostate shape.

Advantages of Transurethral Water Vapor Thermal Therapy (Rezūm)

• May be done under local anesthesia 
• Allows for treatment of enlarged prostate tissue 
• Associated with minimal adverse events 
• Has minimal sexual side effects such as retrograde ejaculation or erectile dysfunction 
• Has consistent outcomes in relieving LUTS, improving urinary flow, and improving quality of life

Disadvantages of Transurethral Water Vapor Thermal Therapy (Rezūm)

• May require longer catheterization time as the patient will be discharged with an indwelling urinary catheter for three to seven days 
• May result in an increased duration of dysuria, sensation of pain, or burning associated with urination 
• Not all people are candidates for this procedure

2. Research, Clinical Trials, and Evidence Summaries
3. Clinical research shows that the water vapor thermal therapy is a safe and effective procedure to relieve LUTS due to BPH and the treatment appears effective for at least five years.

• McVary et al. (2021) conducted a multicenter randomized sham-controlled trial investigating water vapor therapy (Rezūm) treatment of moderate to severe LUTS due to BPH. The study included 197 patients over 50 years of age with International Prostate Symptom Score (IPSS) of 13 or greater, maximum flow rate of 15 ml/second or less, and prostate volume of 30 to 80 cc. The number of vapor treatments applied to each prostate lobe was determined by length of prostatic urethra and included middle lobe treatment per physician discretion. Within three months, patients showed significant LUTS improvements, including a 48% reduction in IPSS, a 45% increase in quality of life, a 44% improvement in maximum urine flow rate, and a 48% decrease in BPH Impact Index. The surgical re-treatment rate was 4.4%, with no reported issues of sexual dysfunction or sustained erectile dysfunction related to the device or procedure. Authors concluded that minimally invasive treatment with water vapor thermal therapy provides significant symptom relief and flow rate improvements through five years, with low surgical re-treatment rates, and without impacting sexual function.

• Woo et al. (2023) conducted a single-arm study to evaluate the safety and efficacy of water vapor thermal therapy in patients with symptomatic BPH and larger prostate glands, ranging from 80.8 to 148.1 cm³. The study included 47 participants over the age of 50 with prostate volumes greater than 80 cm³ and up to 150 cm³. Using the Rezūm system, sterile water vapor was delivered via a transurethral approach to targeted areas of prostate tissue. The primary outcome measure was the response to therapy, defined as at least a 30% improvement in IPSS at six months. The primary safety outcome was a composite of serious device-related adverse events. Secondary outcomes included catheterization rates due to device-related urinary retention. Results showed that all 47 patients completed a six-month follow-up, with 40 patients also completing a 12-month follow-up. At six months, 83% of patients were treatment responders according to the primary efficacy endpoint. The mean IPSS improvement at six months was 11.9 with a variance of 7.5 points, reflecting a significant improvement in symptoms. The primary safety outcome was met, with no occurrence of device-related safety events. The study is limited by the nonrandomized design and early termination, unrelated to safety or effectiveness. Authors conclude the results are consistent with previous findings for prostate glands of up to 80 cm³ and indicate the safety and efficacy of Rezūm for BPH in patients with a larger prostate.

3. U.S. Food & Drug Administration Information
4. VA generally only approves use of medical devices that have received at least FDA clearance for 510(k) Premarket Notification. The following device has received Premarket Approval from the FDA and is indicated for use in patients to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH.

• To search for devices that have received FDA 510(k) clearance or Premarket Approval (PMA), please visit the FDA Devices database.

Information	Description
Product Name	Rezūm System
PMN Applicant	Nxthera, Inc.
Address	7351 Kirkwood Ln. N. Suite 138 Maple Grove, MN 55369
Approval Date	08/27/2015
Pre-Market Notification	K150786

4. Medicare Coverage Determinations
5. There are no available Medicare national and local coverage determinations for interferential current stimulation therapy. VA and Medicare are governed by separate laws and regulations; thus, VA coverage determinations may be different.

5. Health Care Procedural Coding Information
6. The following CPT^®/HCPCS codes listed in this section are provided for informational purposes only. Inclusion or exclusion of a code does not constitute or imply VA coverage or provider reimbursement. The list of codes may not be all-inclusive since the American Medical Association (AMA) and Centers for Medicare & Medicaid Services (CMS) code updates may occur more frequently than CDI updates. Please refer to section II.a. in this document to review indications and clinical criteria for medical necessity.

The following CPT codes may be considered medically necessary/covered if the indications and clinical criteria outlined in section II.a. are met. Additional codes may also apply.

CPT Code	Description
53854	Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy

CPT copyright ^© 2024 American Medical Association. All rights reserved.

IV. Definitions

Term	Definition
Alpha blocker	A medication that blocks the alpha receptor on cells, resulting in the relaxation of the muscle of the prostate and bladder neck, allowing urine to flow more easily
Bacterial prostatitis	An acute infection of the prostate gland that causes urinary tract symptoms and pelvic pain
Benign prostatic hyperplasia	A condition in which the prostate gland is enlarged and not cancerous
Dutasteride	A medication that helps shrink an enlarged prostate and improve urinary symptoms
Dysuria	The sensation of pain and/or burning, stinging, or itching of the urethra or urethral meatus associated with urination
Finasteride	A medication that blocks the body’s production of a male hormone that causes the prostate to enlarge
Indwelling urinary catheter	A thin, flexible rubber or plastic tube that goes through the urethra into the bladder
International Prostate Symptom Score	A scoring system made up of seven questions related to voiding symptoms – a score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms
Neurogenic bladder	A condition in which the patient lacks bladder control due to a brain, spinal cord, or nerve problem, usually as a result of a chronic disease
Nocturia	The need to get up at night on a regular basis to urinate
Lower Urinary Tract Symptoms	Examples include leaking urine, having sudden and frequent urges to urinate, having a weak stream, or feeling like you can’t empty your bladder
Phosphodiesterase inhibitor 5	A medication that results in smooth muscle relaxation of the bladder and prostate, improving urinary symptoms
Prostate zones	Four major areas of the prostate; the peripheral zone, the central zone, the transition zone, and the anterior fibromuscular stroma
Retrograde ejaculation	When semen enters the bladder instead of emerging through the penis during orgasm
Transurethral	Passing through or performed by way of the urethra
Urethra	The tube that connects from the bladder to the external environment and allows urine to flow out of the body

V. References

Defense Health Agency (2021). Urinary System. TRICARE Policy Manual 6010.63-M. Chapter 04, Section 14.1. Retrieved January 26, 2024 from https://manuals.health.mil/pages/DisplayManual.aspx?SeriesId=TPT5

Lerner, L. B., Barry, M. J., Kumar, A., Gandhi, M. C., Kaplan, S. A., Kohler, T. S., Martin, L., Parsons, J. K., Roehrborn, C. G., Stoffel, J. T., Welliver, C., & McVary, K. T. (2023). Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline. https://www.auanet.org/guidelines-and-quality/guidelines/benign-prostatic-hyperplasia-(bph)-guideline

MCG Health. (2023, September 21). Water Induced Thermal therapy. Ambulatory Care. 27th Edition.

McVary, K. T., Gittelman, M. C., Goldberg, K. A., Patel, K., Shore, N. D., Levin, R. M., Pliskin, M., Beahrs, J. R., Prall, D., Kaminetsky, J., Cowan, B. E., Cantrill, C. H., Mynderse, L. A., Ulchaker, J. C., Tadros, N. N., Gange, S. N., & Roehrborn, C. G. (2021). 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. The Journal of urology, 206(3), 715–724. https://doi.org/10.1097/JU.0000000000001778

Medicare Coverage Database (n.d.). LCD L37808 – Water Vapor Thermal Therapy for LUTS/BPH Retrieved January 24, 2024, from https://www.cms.gov/medicare-coverage-database/search.aspx

U.S. Food & Drug Administration 510(k) Premarket Notification Database. (n.d.). Retrieved January 25, 2024, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm 

Woo, H., Levin, R., Cantrill, C., Zhou, S., Neff, D., Sutton, M., Bailen, J., Darson, M., Horgan, J., Zantek, P., Marty-Roix, R., & Rezūm Clinical Trials Group (2023). Prospective Trial of Water Vapor Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia in Subjects with a Large Prostate: 6- and 12-month Outcomes. European urology open science, 58, 64–72. https://doi.org/10.1016/j.euros.2023.10.006

VI. CDI History/Revision Information

Date	Summary of Update(s)
06/01/2026	Updated “Definitions” section
10/01/2024	New CDI created describing medically necessary indications

---