Transurethral Waterjet Ablation for Benign Prostatic Hyperplasia
Clinical Determination and Indication Number: 00009
Original Effective Date: June 1, 2024
Last Review Date: June 1, 2025
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
This document provides information only on Transurethral waterjet ablation for benign prostatic hyperplasia (BPH). Please refer to the American Urology Association’s BPH guidelines for a comprehensive guide to managing BPH.
- Indications for Transurethral Waterjet Ablation
Transurethral waterjet ablation, (also known as aquablation) is indicated for the treatment of BPH. It will be considered medically necessary when performed ONCE in Veterans that meet ALL the following criteria:- Prostate volume of 50-200 cc by diagnostic imaging
- Persistent moderate to severe symptoms despite maximal medical management including ALL the following:
- International Prostate Symptom Score (IPSS) greater than or equal to 12
- Maximum urinary flow rate (Qmax) of less than or equal to 15 mL/s (voided volume greater than 125 cc) or urinary retention requiring catheterization
- Failure, contraindication, intolerance, or patient refusal to at least three months of conventional medical therapy for Lower Urinary Tract Symptoms (LUTS) with BPH (e.g., alpha-blocker, PDE5 Inhibitor, finasteride/dutasteride)
- Must use an FDA-approved device to perform the procedure
Note: Patient receiving transurethral waterjet ablation must be able to tolerate general anesthesia.
- Limitations/Exclusions
Conditions for which transurethral waterjet ablation are not medically necessary include, but are not limited to, the following:- Chronic prostatitis
- Prostate cancer
- BPH with the presence of a large middle lobe
- Neurogenic bladder
- Transurethral waterjet ablation is not indicated if any of the following are applicable:
- Known or suspected prostate cancer (based on National Comprehensive Cancer Network [NCCN] Prostate Cancer Early Detection guidelines), unless there is a negative prostate MRI or biopsy
- Current bladder calculus
- Active urinary tract or systemic infection
- 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
- For all the conditions/indications not listed in section II.a. of this document, transurethral waterjet ablation is considered not medically necessary due to insufficient evidence of efficacy and safety.
- Description of Treatment
- The AQUABEAM System is an image-guided prostate tissue removal system that uses a high-velocity water jet to ablate a predetermined volume of prostatic tissue.
Aquablation using the AQUABEAM system (PROCEPT BioRobotics) combines the precision of autonomous robotic execution to deliver a high- velocity waterjet via a cystoscopic handpiece with accurate anatomical prostatic mapping using real-time transrectal ultrasound imaging.
The initial part of the surgery involves careful treatment planning tailored to the prostatic anatomy with the preservation of important nearby landmarks, followed by a targeted high-velocity waterjet stream delivered to ablate the obstructing prostatic tissue without use of any heat.
Pre-treatment, transrectal ultrasound (TRUS) maps out the specific region of the prostate to be resected while limiting resection in key anatomical areas such as the bladder neck, ejaculatory ducts, and external urinary sphincter. The resection is then executed automatically via a robotic arm. Multidimensional imaging to map and create the exact treatment plan occurs during the procedure. The procedure takes less than an hour.
Following the ablation and removal of the handpiece, a cystoscopic bladder washout and establishment of hemostasis is performed. Patients may go home with a urinary catheter.
The most common side effects of the procedure are mild and transient and may include mild pain or difficulty when urinating, discomfort in the pelvis, blood in the urine, inability to empty the bladder or a frequent and/or urgent need to urinate, and bladder or urinary tract infection. Other risks include ejaculatory dysfunction and a low risk of injury to the urethra or rectum where the devices gain access to the body for treatment.
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.
- Background of Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is a histological diagnosis characterized by an increased number of epithelial and stromal cells in the prostate. It is common in individuals with prostates over the age of 40, and the incidence increases with age. In the United States, 8 million individuals with prostates over the age of 50 years suffer from BPH. In many cases BPH is asymptomatic, however, symptoms may occur with prostate enlargement and compression of the urethra leading to bothersome lower urinary tract symptoms (LUTS), including voiding symptoms such as hesitancy, weak stream, straining, prolonged voiding, and storage symptoms (frequency, urgency, and nocturia).
LUTS can be subdivided into symptoms of urinary storage (e.g., urgency, frequency, and nocturia), urinary voiding (e.g., straining to void, urinary intermittency, dysuria, and hesitancy), and post-voiding symptoms (e.g., sensation of incomplete bladder emptying and post-void urinary dribbling). LUTS/BPH can have a significant impact on the quality of life and can cause serious complications such as infections, bleeding, calculus formation, urinary retention and decline of renal function when untreated.
First line treatment generally consists of medications such as alpha blockers, PDE5 Inhibitors, or finasteride/dutasteride. If treatment with medications is not successful, surgical options may be considered. Transurethral resection of the prostate (TURP) and open simple prostatectomy (OSP) are the standard surgical treatments for LUTS/BPH and are highly effective and provide improved outcomes in urinary functions. However, neither TURP nor OSP are without considerable perioperative complication and morbidity.
Recently, new techniques have emerged as alternatives for the resection of the prostate to manage LUTS in individuals with BPH. One such surgery is transurethral waterjet ablation; a water-based surgical therapy that combines image guidance and robotics to remove prostatic tissue. The system works by pumping high pressure saline (500 to 8000 pounds per square [PSI]) through a probe nozzle to cut and dissect tissue at predetermined system parameters.
Recent trials have shown that transurethral waterjet ablation is safe and effective in the treatment of symptomatic BPH while maintaining sexual preservation.
- Research, Clinical Trials, and Evidence Summaries
The American Urological Association’s guidelines on the Management of BPH/LUTS (2021) are based on the best available evidence of literature and scientific data that identify characteristics and components of quality of care. It provides a useful reference on the effective evidence-based surgical management of male lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH).
The American Urological Association includes robotic waterjet treatment (RWT) in its surgical practice guidelines as a treatment option for patients with LUTS/BPH provided prostate volume 30-80cc. (Conditional Recommendation; Evidence Level: Grade C).
- Conditional Recommendations are non-directive statements used when the evidence indicates that there is no apparent net benefit or harm or when the balance between benefits and risks/burdens is unclear
- Evidence Level: Grade C means that the balance between Benefits & Risks/Burdens is unclear. Alternative strategies may be equally reasonable. Better evidence is likely to change confidence
According to the American Urological Association, the technique is not in the MIST (Minimally Invasive Surgical Technique) category as patients must undergo general anesthesia.
Studies and recommendations demonstrate the safety and effectiveness of aquablation as an option for individuals aged equal to or less than 80, with moderate to severe LUTS due to BPH as indicated by International Prostate Symptom Score (IPSS) equal to or greater than 12 and a 30-80 cc prostate. In addition, the ability to preserve sexual function is a major consideration for this treatment.
Nguyen et. al (2019) compared the outcomes of aquablation in 30-80mL prostates from the WATER I clinical trial with the outcomes in 80-150mL prostates from the WATER II clinical trial to determine if the effectiveness of aquablation is independent of prostate size. The team found that the effectiveness of aquablation is independent of prostate size and is a safe and effective treatment option in small-to-moderate sized (30–80 mL) and large- to-very-large (80–150 mL) prostates.
Initial clinical experience reported in 2016, the WATER (Waterjet Ablation Therapy for Endoscopic Resection) of prostate tissue trial, a PHASE III multicenter international, double-blind, randomized, non-inferiority study (cohort consisted of individuals aged 45–80 year with a prostate of 30–80 cm) with 181 subjects comparing aquablation (116/181) to TURP (65/181) showed a change in the IPSS at six months; scores decreased by 16.9 points and points for aquablation and 16.1 for TURP, respectively. At two years, IPSS score improvement was sustained (14.7 in aquablation and 14.9 in TURP).
A 2019 Cochrane Review based on 1-year aquablation trial results, found evidence of similar results with TURP to be of moderate certainty related to the urologic symptom score (IPSS) primary outcome measure.
In a study by Nguyen DD, Barber N, Bidair M et al, the authors conclude outcomes and effectiveness of aquablation are comparable and are independent of prostate size with the expectation that with larger prostates a higher risk of complication is possible.
Canadian Urological Association (CUA) 2018 guidelines give a “conditional recommendation based on moderate-quality evidence” that aquablation may be offered to individuals “interested in preserving ejaculatory function, with prostates less than 80 cc, with or without a middle lobe.
A 2018 National Institute for Health and Care Excellence (NICE) systematic review based on 6-month WATER results concluded the procedure should only be used with “special arrangements,” a defined designation meaning there are uncertainties about safety and effectiveness.
In an April 2020 study by Desai et. al. provides strong evidence that aquablation provides excellent mid-term (2 year) long-term relief of LUTS related to BPH.
Five-year outcomes from WATER (NCT02505919) demonstrate BPH symptom reduction and urinary flow rate improvement similar to TURP in participants with prostate sizes between 30 and 80 cc.
A study of Robotic Water Jet Ablation vs TURP functional outcomes from two FDA clinical trials conducted in 2022 by The Weill Medical College of Cornell University/ New York Presbyterian and Icahn School of Medicine at Mount Sinai concluded that Robotic Waterjet Treatment (RWT) and TURP are effective BPH therapy in patients who truly failed medical therapy, and RWT demonstrated this in a much broader prostate size range. Functional outcomes did not statistically differ between RWT and TURP at baseline and at 36 months. RWT demonstrated non-inferiority. In a pre-specified analysis, RWT showed superior results in symptom reduction compared to TURP in prostate sizes 50-80cc. This sub-analysis of the medical therapy failure cohort further reinforces the role of these therapies as the treatment of choice for medical therapy failures including those who desire to limit their sexual adverse events from surgical therapies.
- U.S. Food & Drug Administration Information
- VA generally only approves use of medical devices that have received at least Food & Drug Administration (FDA) clearance for 510(k) Premarket Notification. The FDA has determined these Class II devices are substantially equivalent (SE) to legally marketed predicate devices and may be marketed in the U.S.
- To search for devices that have received FDA 510(k) clearance or Premarket Approval (PMA), please visit the FDA Devices database.
- Medicare Coverage Determinations
- Available Medicare national and local coverage determinations are listed below as a resource. VA and Medicare are governed by separate laws and regulations; thus, VA coverage determinations may be different.
| NCD Number | Name | Effective Date |
|---|---|---|
| None | N/A | N/A |
| LCD Number | Contractor | Original/Revision Effective Date |
|---|---|---|
| L38726 | First Coast Service Options | 04/06/2025 |
| L38705 | Noridian Healthcare Solutions | 03/05/2026 |
| L38712 | Novitas Solutions | 04/06/2025 |
| L38549 | Palmetto GBA | 12/14/2025 |
| L38682 | WPS Insurance Corporation | 12/14/2025 |
- NCD: National Coverage Determination
- LCD: Local Coverage Determination
- Health Care Procedural Coding Information
- 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 are 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 |
|---|---|
| C2596 | Probe, image guided, robotic, waterjet ablation |
| 0421T | Transurethral waterjet ablation of prostate, including control of post-operative bleeding, including ultrasound guidance, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included when performed) |
CPT copyright 2026 American Medical Association. All rights reserved.
IV. Definitions
| Term | Definition |
|---|---|
| Ablation | A procedure where a type of energy is used to remove or destroy targeted tissue in the body |
| Benign | Non-cancerous tumor, not harmful in effect |
| Bladder Calculus | Bladder Calculi, or stones, are hardened clumps of minerals that form in the bladder. Urinary stasis, such as with BPH, radiation therapy, schistosomiasis, bladder augmentation surgery, urethral strictures, and the presence of bladder diverticula are predisposing factors to bladder stone formation. Stones can also form in healthy individuals without anatomic defects, foreign bodies, strictures, or infections |
| Bladder Diverticulum | An out-pouching of the bladder that occurs when a part of the bladder lining protrudes through a weakness in the bladder wall. These occur either congenitally or as an acquired condition from bladder outlet obstruction, neurogenic bladder conditions, or from prior bladder surgery |
| Bladder Neck Contracture | Scar tissue in the bladder neck that can make the bladder neck narrow and more difficult for urine to flow through it |
| Histology | The study of the microscopic tissue structures |
| Hyperplasia | The enlargement of an organ or tissue caused by an increase in the reproduction rate of its cells |
| International Prostate Symptom Score | International Prostate Symptom Score is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia |
| Meatal Stenosis | Narrowing of the opening of the urethra, the tube through which urine leaves the body |
| Minimally Invasive Surgical Technique | A low-risk surgical technique that can be performed in an outpatient setting (e.g., in an office or ambulatory care setting) |
| Morbidity | Refers to having a disease or a symptom of disease, or to the amount of disease within a population. Morbidity also refers to medical problems caused by a treatment |
| Neurogenic Bladder | A condition in which the patient lacks bladder control due to brain, spinal cord, or nerve problem, usually as a result of chronic disease |
| Nocturia | The need to get up at night on a regular basis to urinate |
| Prostatectomy | A surgical procedure for the partial or complete removal of the prostate |
| Transrectal | Passing through or performed by way of the rectum |
| Transurethral | Passing through or performed by way of the urethra |
| Urethral Stricture | A narrowing of the urethra, usually caused by scar tissue, causing obstructive symptoms |
V. References
Landmark Medical Center. (2022). Aquablation. Retrieved May 2, 2023.
Lerner LB, McVary, KT, Barry MJ et al: Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia: AUA Guideline part I, initial work-up and medical management. J Urol 2021; 206:806,818.
Lim Ng, K., & Barber, N. (2019). Prostatic hydroablation (Aquablation): A new effective ultrasound guided robotic waterjet ablative surgery for treatment of benign prostatic hyperplasia. 72(8), 786–793.
MacRae, C., Gilling, P. (2016). How I do it: Aquablation of the prostate using the A beam system. Retrieved April 26, 2023.
Medicare Coverage Database (n.d.) Retrieved May 4, 2023.
NCI Dictionary of cancer terms. (n.d.). National Cancer Institute.
Te, A. E., Sze, C., Kaplan, S. A., & Chughtai, B. (2023). Surgical treatment for BPH refractory to medication: robotic water jet ablation vs. TURP functional outcomes from two FDA clinical trials. The Canadian journal of urology, 30(1), 11408– 11413.
University of Michigan Health. (n.d.). Neurogenic bladder. Michigan Medicine.
Yale Medicine. (2022). Minimally invasive surgery. Yale Medicine. Retrieved May 3, 2023.
VI. CDI History/Revision Information
| Date | Summary of Updates |
|---|---|
| 06/01/2025 | Updated the Medicare Coverage Determinations section LCD Revision Effective Dates Updated the Health Care Procedural Coding Information section with AMA disclaimer content Updated Definitions section |