Transurethral water vapor thermal therapy and transurethral waterjet ablation (Aquablation) have been investigated as minimally invasive alternatives to transurethral resection of the prostate (TURP), considered the traditional standard treatment for benign prostatic hyperplasia (BPH). 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.
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 trial 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). Nonrandomized studies comparing transurethral water vapor thermal therapy with prostatic urethral lift have generally found the need for more reintervention with prostatic urethral lift but more complications with transurethral water vapor thermal therapy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have BPH and LUTS who receive Aquablation, the evidence includes a single noninferiority randomized controlled trial (RCT) of Aquablation compared to TURP in 187 patients with 5 years of follow-up, and several multicenter, prospective, single-arm studies. The outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The primary efficacy endpoint in the RCT was the difference between groups in the change in International Prostate Symptom Score (IPSS) at 6 months, and the primary safety endpoint was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications at 3 months. At 6 months, mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP (mean difference, 1.8 points; p<.0001 for noninferiority and p=.1347 for superiority). The primary safety endpoint rate was lower in the Aquablation group compared to the TURP group (26% vs. 42% ; p=.0149). The rate of grade 2 and greater events was similar in the 2 groups (20% for Aquablation and 23% for TURP; p=.3038). Over 5 years, improvements remained similar between groups with no new safety signals. Confidence in these conclusions is reduced due to imprecision of estimates and a lack of additional supportive trials, especially with regard to comparative adverse events. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Transurethral water vapor thermal therapy is considered investigational as a treatment of benign prostatic hyperplasia.
Transurethral waterjet ablation (Aquablation) is considered investigational as a treatment of benign prostatic hyperplasia.
| CPT | 52597 | Transurethral robotic-assisted waterjet resection of prostate, including intraoperative planning, ultrasound guidance, control of postoperative bleeding, complete, including vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy, when performed (new eff 1/1/26) |
| 53854 | Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy | |
| 55899 | Unlisted procedure, male genital system |
| C2596 | Probe, image-guided, robotic, waterjet ablation |
| CD-10 Diagnosis Codes | N40.0 | Benign prostatic hyperplasia without lower urinary tract symptoms |
| N40.1 | Benign prostatic hyperplasia with lower urinary tract symptoms |
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.1, 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.2,
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.3, Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra.
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 at least 50 years of age with a prostate volume between 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).4, The device is intended for the resection and removal of prostate tissue in males with LUTS due to BPH, based on WATER trial.
