Fluid Jet System Treatment for LUTS/BPH

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1862(a)(1)(D) refers to limitations on items or devices that are investigational or experimental.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Publications:

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 14,

10 Coverage of Medical Devices

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 23,

30 Services paid under the Medicare Physicians Fee Schedule

CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13,

5.1 Reasonable and necessary provisions in LCDs

7.1 Evidence supporting LCDs.

This LCD addresses use of the fluid jet system treatment of lower urinary tract symptoms attributable to benign prostatic hyperplasia (LUTS/BPH).

Indications

Treatment for LUTS/BPH will be considered reasonable and necessary when performed ONCE in patients with the following:

1. Indications including ALL of the following:
   
   1. Prostate volume of 30-150 cc by transrectal ultrasound (TRUS)^1,2
   2. Persistent moderate to severe symptoms despite maximal medical management including ALL of the following:
      1. International Prostate Symptom Score (IPSS) ≥12¹
      2. Maximum urinary flow rate (Qmax) of ≤15 mL/s (voided volume greater than 125 cc)¹
      3. Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)

2. Only treatment using an FDA approved/cleared device will be considered reasonable and necessary.

Limitations

The following are considered not reasonable and necessary:

1. Body mass index ≥ 42kg/m2
2. Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines⁴) or a prostate specific antigen (PSA) >10 ng/mL unless the patient has had a negative prostate biopsy within the last 6 months.
3. Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum³
4. Active urinary tract or systemic infection⁵
5. Treatment for chronic prostatitis³
6. Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture³
7. Damaged external urinary sphincter³
8. Known allergy to device materials⁵
9. Inability to safely stop anticoagulants or antiplatelet agents preoperatively.⁵

Background

Benign prostatic hyperplasia (BPH) is a histological diagnosis defined as an increased number of epithelial and stromal cells in the prostate. It is common in men over the age of 40, and the incidence increases with age. In the United States, 8 million men older than 50 years old suffer from BPH. Many cases are 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). Serious consequences can develop, including acute urinary retention, recurrent urinary tract infections, bladder stones and diverticula, hematuria, and renal insufficiency⁷. The condition impacts quality of life (QOL) and is a substantial economic burden with a US estimated annual expenditure over 4 billion dollars⁸.

Treatment for BPH varies based on symptom severity and ranges from conservative management (monitoring, lifestyle modifications), to medical management (alpha-blockers, 5-alpha-reductase inhibitors, antimuscarinic and beta-3 agonists), and finally surgical treatment in approximately 25% of men over 50 years old. Transurethral resection of the prostate (TURP) is considered the gold standard surgical intervention for BPH secondary to small to medium size prostates (30-80 cc). Interest in alternative surgical options arises from the complications associated with TURP, including dilutional hyponatremia (TUP syndrome), sexual dysfunction (erectile dysfunction (6.5%), anejaculation (>5%) retrograde ejaculation (53-75%)), infection, urethral strictures, bladder neck stenosis or contracture, and hematuria^7,9. The most common surgical procedure for large prostates (> 80 cc) is simple prostatectomy, which is effective with a low re-operation rate, but requires an abdominal approach and has a higher risk of bleeding, longer hospital stay (5 days), and catheterization times. Laser enucleation with holium (HoLEP) or thulium (ThuLEP) laser is an option for large prostates and offers shorter hospital stay and less bleeding, but is technically challenging with limited use in the United States¹⁰.

In recent years, minimally invasive treatment options have emerged with the main goal to be equally effective to TURP, but with a more favorable safety and convenience profile. Ideally, this includes the rapid and durable relief of LUTS without compromise of sexual function, under local anesthesia in an ambulatory setting, with a short convalescence¹¹. Increasingly, a balance between symptomatic improvement in LUTS and preservation of sexual function is expected¹².

The only FDA cleared (De Novo classification for the resection and removal of prostate tissue for the treatment of LUTS resulting from BPH) Fluid Jet System, is the AquaBeam System (PROCEPT BioRobotics)⁵. This transurethral approach uses a high-velocity saline jet and real-time ultrasound imaging with robotic assistance for targeted removal of prostate parenchyma while ideally sparing collagenous structures (blood vessels, surgical capsule, bladder neck). Pre-treatment, transrectal ultrasound (TRUS) maps out the specific region of the prostate to be resected while limiting resection in key anatomical areas (bladder neck, vermontanum, ejaculatory ducts, external urinary sphincter). Although resection limits are automatically computer generated, the surgeon ultimately defines the area of treatment, and the resection is then executed automatically via a robotic arm. After completion, flushed tissue particles can be sent for histological analysis; hemostasis is achieved using electro-cautery or traction from a 3-way catheter balloon. By minimizing conductive heat damage to erective nerves, Aquablation has a theoretical advantage in preserving sexual function. Operative time is reportedly short (mean 33 minutes)^6,8, and trials of novice users report a short learning curve¹³. Surgeons rate the procedure to be of similar to less work than TURP or other open/robotic-assisted procedures¹⁰.

Primary Evidence

Initial clinical experience was reported in 2016, and the technology obtained FDA clearance in 2017 after the publication of the WATER trial, a PHASE III multicenter international, double-blind, randomized, non-inferiority study with 181 subjects comparing Aquablation (116/181) to TURP (65/181)^14,15. Men 45-80 years old with prostate size 30-80 cc (by TRUS), moderate-severe LUTS (International Prostate Symptom Score (IPSS) ≥ 12), and maximum urinary flow rate (Qmax) <15ml/s were included and stringent exclusion criteria applied. After randomization, although treatment was by an unblinded research team, a separate blinded team performed all follow-up. The primary endpoint was the change in the IPSS at six months; scores decreased by 16.9 points and 15.1 points for Aquablation and TURP, respectively (noninferiority p<.0001 and superiority p=0.1347). The primary safety endpoint was the proportion of subjects with adverse events, defined as Clavien-Dindo grade 2 or higher or any grade 1 with persistent disability. The 3-month primary safety endpoint rate was lower in the Aquablation group than in the TURP group (26% vs 42%, p = 0.0149). The rate of persistent grade 1 events was lower after Aquablation (7% vs 25%, p = 0.0004), while the rate of grade 2 and greater events was similar (20% for Aquablation, 23% for TURP (p = 0.3038)). Safety results remained consistent at 6 months.

At two years, 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 both groups (11.2 and 8.6 cc/s for Aquablation and TURP, respectively (p = 0.1880, 95% CI for difference -1.3 to 6.4)¹⁶. Two-year reduction in post-void residual (PVR) was 57 and 70 cc for Aquablation and TURP, respectively (p = 0.3895). Prostate specific antigen (PSA) decreased significantly in both groups by 1 point (p < 0.01). Retreatment rates were 4.3% and 1.5% (p = 0.42) in the Aquablation and TURP groups, respectively. Among the subset of sexually active men without the condition at baseline, anejaculation was less common after Aquablation (10% vs. 36%, p=0.0003). , post-Aquablation cautery was avoided, rates of anejaculation were lower (7% vs. 16%, p=0.1774), and this resulted in the reduced grade 1 persistent events found in the Aquablation group. The authors hypothesize that Aquablation avoids damage to tissues involved in ejaculation though precise, image-based targeting, and robotic execution. Limitations of the study include the risk of performance bias as surgeons were not blinded, and unknown generalizability to a broader population¹⁶. Three-year results were essentially unchanged providing mid-term data on efficacy and safety.

WATER II was a prospective, uncontrolled, multi-centered international clinical trial to determine if the Aquablation technique was safe in men with large prostates (80-150 cc)^2,17,18. The mean prostate size was 107mL (range 80-150cc) with a middle lobe in 83%. Mean operative time was 37 minutes, mean resection time 8 minutes, and average length of hospital stay 1.6 days. Functional outcomes such as IPSS and Qmax, were similar to those seen in the Water study. The primary safety endpoint, defined as CD Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g., ejaculatory disorder, erectile dysfunction, or permanent incontinence), at 3 months occurred in 45.5%, which met the study design goal of less than 65% (P <0.0001). Ejaculatory dysfunction occurred in 19% of sexually active men. While no electrocautery was used at time of surgery, 10 patients required transfusion and five cryptoscopic fulgurations for delayed bleeding. Severe hemorrhage rate for open simple prostatectomy is reported from 7-29%, but lower for alternative laser procedures⁹. The 2-year data (n=86) reported reoperation rate of 2%². Complication rates are higher for larger prostates as they are typically more vascular and difficult to treat and the presence of middle lobe also makes this technically more difficult. A comparison of 1-year WATER I and WATER II results were similar except for an expected increase in the risk of complications in larger prostates (by 3 months, Clavien-Dindo grade ≥ II events occurred in 19.8% of WATER I patients and 34.7% of WATER II patients (p = 0.468)). 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 possible³.

A 2019 prospective, single-center, cohort study conducted in Germany evaluated the applicability of Aquablation to a non-selected patient collective¹⁹. 118 consecutive patients with symptomatic BPH were enrolled and followed for 3 months post-procedure. Mean prostate volume at time of enrollment was 64.3 ± 32ml (range 20-154 ml); the number >80ml was not reported. Aquablation was successfully performed in all, with 10% experiencing significant bleeding requiring transfusion (2.5%) or second surgical intervention for bleeding (3.4%). IPSS, Qmax, and PVR improved significantly post procedure and out to 3 months. The same author also published in 2020 a multi-center trial of Aquablation procedure performed in commercial setting with prostates ranging from 20-150ml in volume and reported similar safety and effectiveness outcomes. The mean IPSS reduction at one year was 15.3 and comparable to the reduction of 15.1 and 17.0 at one year in WATER and WATERII studies, respectively. The most common complication reported was post-procedure bleeding, however large prostate size predisposes to this risk and modification in technique improved bleeding outcomes in later portion of the study²⁰.

A 2019 Cochrane Review based on 1-year WATER trial results, found evidence of parity with TURP to be of moderate-certainty related to the urologic symptom score (IPSS) primary outcome measure. All other metrics were graded low-certainty (QOL), to very low-certainty (adverse events, retreatments, erectile function, ejaculatory dysfunction)¹. Evidence was downgraded mainly due to study limitations (performance, reporting, and attrition bias), and imprecision (confidence intervals that crossed the assumed thresholds of clinically important differences or few events, or both). For example, both sexual outcome (erectile and ejaculatory function) results were downgraded two levels for a combination of imprecision and study limitations (high risk of performance and attrition bias). The authors recommend larger, more rigorously conducted, and transparently reported, studies comparing Aquablation to other techniques (laser enucleation, prostatic urethral lift, robotic-assisted simple prostatectomy) for which there is also increasing interest. However, this report was limited to the first 12 months of the WATER1 data⁷.

A 2019 systematic review reports on functional (IPSS, Qmax, QOL, PVR), sexual (erectile dysfunction, anejaculation), and safety outcomes²¹. Nine studies were examined for a total of 445 patients screened. In addition to WATER I (1-year) and WATER II, a WATER I cohort analysis²², pooled analysis on WATER I and II cohorts²³, and WATER II subpopulation analysis were included¹³. The review reports improved outcomes in all functional outcome criteria for Aquablation, and statistical non-inferiority to TURP. In terms of safety, in the trials that compared Aquablation to TURP, outcomes (bleeding, urethral strictures, urinary retention, UTI, dysuria, bladder spasm, voiding dysfunction) were similar. Sexual outcomes, available in five papers, appear promising with International Index of Erectile function (IEEF-5) reduced as compared to TURP (33% vs. 56% in sub-analysis of WATER I, p=0.025). In two papers, there were no post-treatment erectile dysfunction^13,23, and one paper reported no difference from baseline ²⁴. Ejaculation rates also show better maintenance after Aquablation, with lower rates of anejaculation, compared to TURP. In a population of 92 patients, no significant decrease in Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) at three months was reported²⁴. The review was limited by relatively small sample size and follow-up compared to other standard techniques, extreme heterogeneity in the description, and even reporting, of many outcomes (especially sexual), and lack of standardized validated questionnaires. The authors conclude that other multicenter randomized comparison trials (vs. TURP and laser therapy) with larger cohorts and longer follow-up are needed.

The original studies excluded men over the age of 80 therefore data supporting use in that population was lacking. Additional literature has been submitted that included men ≥ 80 years old. A 2020 real world report of experience with Aquablation in a single center in US reported on 55 men with mean prostate volume of 100cc (range 27-252cc) and 85% had prominent obstructing middle lobe reported successful outcomes and similar length of hospital stay, BPH symptom reduction and Qmax improvement in those with prostate volume >100cc compared to <100cc. Age of subjects included men >80 (range 50-84), but the number of subjects over 80 was not reported. Limitations include the lack of reporting the number of subjects in each group, risk of bias (industry sponsor conducted data analysis) and study design.²⁸ A 2020 prospective observational study reported on 59 men who underwent Aquablation aged 54-86 (the distribution of age was not reported) and reported positive outcomes including several inexperienced surgeons. In the 2020 International prospective OPEN WATER study included all comers with BPH and prostate size 20-150cc. ²⁷ They reported IPSS decrease from 21.6 at baseline to 6.5 at 12-months (p= <0.0001). They included men ages 38-88 with mean age 68 (age distribution was not reported) ²⁹

American Urological Association (AUA) amended guidelines now include Aquablation, but do not classify it as a minimally invasive surgical treatment (MIST) since general anesthesia is required. Based on 1-year WATER study results, they find parity between Aquablation and TURP on IPSS, LUTS, and QOL scores (Quality of Evidence: Moderate). Their recommendation: “Aquablation may be offered to patients with LUTS attributed to BPH provided prostate volume >30/<80g”²⁵ (Conditional Recommendation; Evidence Level: Grade C)”.

Canadian Urological Association (CUA) 2018 guidelines also give a “conditional recommendation based on moderate-quality evidence” that Aquablation may be offered to men “interested in preserving ejaculatory function, with prostates <80 cc, with or without a middle lobe”⁹.

European Association of Urology (EAU) guidelines states: “The first clinical experience provides encouraging results, with a low risk of sexual dysfunction, but further modifications of the AquaBeam system may be necessary. Longer term follow up would help assess the clinical value of Aquablation”²⁶. They state Aquablation appears to be as effective as TURP both subjectively and objectively; however, there are still some concerns about the best methods of achieving post-treatment hemostasis (Strength of rating 1b)²⁶.

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 effectiveness²⁷.

In summary, promising short-term, single study, Aquablation results have resulted in conditional recommendations in some guidelines (AUA, CUA, NICE). A conditional recommendation with Grade C evidence level (AUA) which translates to “Balance between Benefits & Risks/Burdens unclear Alternative strategies may be equally reasonable Better evidence likely to change confidence”, echoing the Cochrane Review recommendation: “any recommendation for or against the use of Aquablation would be based on only very low-certainty evidence.” However, these guideline recommendations predate publication of mid-term (3-year) results, which demonstrate persistent similar outcome with TURP.⁴ These studies and recommendations demonstrate the safety and effectiveness of Aquablation as an option for men aged equal to or less than 80, with moderate to severe LUTS due to benign prostate hyperplasia as indicated by International Prostate Symptom Score (IPSS) equal to or greater than 12 and a 30-80 cc prostate. Also, the ability to preserve sexual function is a major consideration.

Further follow-up reports 2-year safety and effectiveness of the Aquablation procedure for treatment with men with symptomatic benign prostatic hyperplasia (BPH) and large volume 80-150 cc prostates.

The initial non-coverage policy by NGS predated the publication of mid-term (3-year) results, which demonstrates persistent outcome parity with TURP.

NGS reconsidered the initial non-coverage decision after the publication of the WATER I 3-year data, which was released after the draft policy was posted, and provided sufficient evidence in support of use of the technology for prostates 30-80 cc range. The use of the technology in prostates between 80-150cc is supported by the WATERII data. There is less clarity on the benefits in this population, however, given the limited access to laser treatments for large prostates in the U.S. and the potential for lower morbidity as compared to the alternative procedure of open prostatectomy, we will allow expansion to 150 cc conditional on continued positive outcomes in real world population.

Therefore, NGS considers water jet treatment of LUTS/BPH to be medically reasonable and necessary when performed as outlined in this LCD.

A 2023 reconsideration request to remove the limitation of age >80 was received and submitted literature reviewed. Several real-world studies that included men greater than the age of 80 were submitted. While the quality of evidence is weak it does demonstrate the utilization of the procedure in this age population. Significantly the five-year WATER trail data shows positive long-term outcomes and a less invasive approach in the octogenarian population may be beneficial therefore the limitation has been removed from the policy.

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26. Gravis S, Cornu JN, Gratze, C, et al. EAU Guidelines: Management of Non-neurogenic Male LUTS; Chapter 5: Disease Management. 2019; https://uroweb.org/guidelines/management-of-non-neurogenic-male-luts. Accessed 9/14/2020.
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