LCD L38367: Fluid Jet System Treatment for LUTS/BPH

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:

• Indications including ALL of the following:

• Prostate volume of 30-150 cc 1,2

• Persistent moderate to severe symptoms despite maximal medical management including ALL of the following:

• International Prostate Symptom Score (IPSS) ≥12 1

• Maximum urinary flow rate (Qmax) of ≤15 mL/s 1

• Failure, contraindication or intolerance to at least three months of conventional medical therapy for LUTS/BPH (e.g., alpha blocker, PDE5 Inhibitor, finasteride/dutasteride)

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

Limitations

The following are considered not reasonable and necessary:

• Body mass index ≥ 42kg/m2

• Known or suspected prostate cancer (based on NCCN Prostate Cancer Early Detection guidelines 4 ) or a prostate specific antigen (PSA) > 10 ng/mL unless the patient has had a negative prostate biopsy within the last 6 months.

• Bladder cancer, neurogenic bladder, bladder calculus or clinically significant bladder diverticulum 3

• Active urinary tract or systemic infection 5

• Treatment for chronic prostatitis 3

• Diagnosis of urethral stricture, meatal stenosis, or bladder neck contracture 3

• Damaged external urinary sphincter 3

• Known allergy to device materials 5

• 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 insufficiency 7 . The condition impacts quality of life (QOL) and is a substantial economic burden with a US estimated annual expenditure over 4 billion dollars 8 .

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 States 10 .

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 convalescence 11 . Increasingly, a balance between symptomatic improvement in LUTS and preservation of sexual function is expected 12 .