What Are The Risks Associated With Aquablation Therapy
The most common side effects are mild and temporary. These may include mild pain, bleeding or strain while peeing, discomfort in the pelvis, inability to empty the bladder, 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. For more information about potential side effects and risks associated with Aquablation therapy, speak with your urologist or surgeon.
For more information, visit the Safety Information page.
What Is Aquablation Therapy
Aquablation therapy is a one-of-a-kind procedure. It is the only procedure that uses a heat-free waterjet controlled by robotic technology to remove prostate tissue and combines a camera with ultrasound imaging, giving the surgeon the ability to see the entire prostate in real time. As a result, Aquablation therapy is precise, consistent and predictable and provides long-term relief no matter how large your prostate is, and has a very low rate of irreversible complicationsincontinence, ejaculatory dysfunction, erectile dysfunction.1,2
For more information, visit our Aquablation Therapy page.
References:1. Gilling, P, et al. Three-Year Outcomes after Aquablation Therapy Compared to TURP: Results from a Blinded Randomized Trial. Can J Urol. 2020 Feb 27:10072-10079.2. Bhojani, N, et al. Aquablation for Benign Prostatic Hyperplasia in Large Prostates : 1-Year Results. Urology. 2019 Jul 129:1-7.
Approved By Governing Bodies:
Multiple instruments including energy-delivery devices employing microwave, radiofrequency, electrical, laser energy, and bipolar plasmakinetic electrovaporization for ablative and vaporization applications balloons and stents have received FDA approval.
The Spanner temporary prostatic stent received approval from the U.S. Food and Drug Administration on December 14, 2006 through the premarket approve or PMA process. The device is intended for temporary use to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia and after initial post-treatment catheterization.
The Rezum System received FDA 510designation on August 27, 2015. In February 2018, the 510 was renewed and approved intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men 50 years of age with a prostate volume 30cm3 and 80cm3. The Rezm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
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Cyp17 Rs743572 Polymorphism In Benign Prostatic Hyperplasia
Weng and colleagues stated that many published studies have examined the association between CYP17 rs743572 polymorphism and BPH susceptibility but have yielded inconsistent results. These investigators carried out a meta-analysis using the multi-variate statistic method to address a more precise association. Case-control or cohort studies with adequate genotype distribution or minor allele frequency were identified by searching the PubMed, Embase, and Web of Science databases up to December, 2018 ORs and 95 % CIs were calculated to estimate the association between CYP17 rs743572 polymorphism and BPH susceptibility. Pooled MAFs of 13 studies were 37 % in Caucasians and 56 % in Orientals, respectively. Pooled results of 8 studies suggested that CYP17 rs743572 was not associated with the BPH susceptibility in the overall population . Sensitivity analysis showed the results were robust. Subgroup analysis based on ethnicity suggested that, in Orientals, A2 allele carriers had a 28 % lower risk of developing BPH compared with A1 allele carriers, and the risk of BPH is 47 % lower in A2/A2 genotype carriers compared with A1/A1 genotype carriers. No significant association was observed in Caucasians. The authors concluded that the findings of this study indicated a negative association between CYP17 and BPH in Orientals. However, due to limited sample size, the conclusion should be interpreted with caution and further studies with large sample size and high quality are needed.
What Are The Benefits Of The Procedure
Transurethral needle ablation has many advantages, and the patients prefer to undergo this procedure as it saves them from the trauma of surgery. The benefits of the procedure have been listed below:
The risk of bleeding is very low, so the patients on anticoagulant therapy need not worry. They can undergo the procedure easily without severe bleeding.
There is no need to stay in the hospital for long, as the discharge is done on the same day. The healing gets completed in four to six weeks.
The procedure is carried out under local anesthesia, so the patient is aware of his surroundings.
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American Hospital Association Disclaimer
The American Hospital Association has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.
Recovery From A Transurethral Needle Ablation
Most patients need to have a catheter in place for one to three days post-surgery and will need to take an antibiotic to prevent infection.
After the procedure, you may notice the following symptoms:
- Blood in the urine
- Urinary symptoms such as urgent need to urinate or need to get up frequently during the night
- Burning sensation after urinating that can last as long as a week
- Urinary tract infection
Measurement Of Seminal Cell Free Dna Concentration For Differential Diagnosis Of Prostate Cancer And Bph
Ponti and colleagues noted that seminal plasma cfDNA was recently proposed as a novel PCa biomarker. These researchers examined if scfDNA could differentiate PCa from BPH patients. A cohort of 43 patients , and 13 healthy age-matched control subjects were enrolled scfDNA quantification was performed. Data were analyzed through ANOVA testing. Average scfDNA concentrations were 1,407.83 ng/l, 128.13 ng/l and 78.09 ng/l for PCa patients, BPH patients and healthy subjects, respectively. Statistical analysis showed a significant difference among the groups, allowing for distinction of patients with optimal accuracy. A cut-off level of 450 ng/l scfDNA was identified for the differentiation of PCa and BPH patients. The authors concluded that scfDNA concentrations were significantly different between PCa patients and BPH patients. They stated that scfDNA is a promising biomarker with several applications in PCa diagnosis, screening programs and therapeutic monitoring.
Cpt Codes Not Covered For Indications Listed In The Cpb:
Prosta-Seq, seminal cell free DNA concentration, measurement of blood-based microRNAs, Histotripsy, Phytotherapy , Rezum system, CYP17 rs743572 polymorphism testing – no specific code 0619T Cystourethroscopy with transurethral anterior prostate commissurotomy and drug delivery, including transrectal ultrasound and fluoroscopy, when performed 0655T Transperineal focal laser ablation of malignant prostate tissue, including transrectal imaging guidance, with MR-fused images or other enhanced ultrasound imaging 0714T Transperineal laser ablation of benign prostatic hyperplasia, including imaging guidance 37242 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention arterial, other than hemorrhage or tumor 37243 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention for tumors, organ ischemia, or infarction 53855 Insertion of a temporary prostatic urethral stent, including urethral measurement 55873 Cryosurgical ablation of the prostate 75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation
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Why Is Transurethral Needle Ablation Done
Transurethral needle ablation needs to be done for patients suffering from benign prostatic hyperplasia. It is a condition in which the prostate gland becomes enlarged. As the prostate gland is present near the urinary bladder, the patient presents with problems in the urinary system. If the patient is unwilling to undergo surgery and other recommended treatment options, transurethral needle ablation needs to be done. So, the patient whose gland is 60 grams or less, and presents with the following symptoms, needs to undergo transurethral needle ablation:
Urinary incontinence or leakage of urine during the day and night.
Hematuria, or the presence of blood in the urine, is seen.
Urinary tract infections and bladder infections occur repeatedly.
The urine does not flow even after a strong urge to urinate.
The patient urinates more than eight to ten times per day.
Nocturia, or the feeling of urinating at night.
Pain and a burning sensation while passing urine.
Difficulty in starting the flow of urine.
Temporary Implantable Nitinol Device For The Treatment Of Bph
In a systematic review, Bertolo and associates provided a narrative synthesis of the available literature regarding the role of the TIND for the treatment of BPH-related LUTS, specifically focusing on the follow-up data. The authors concluded that current available evidences are limited in this topic. Sample size of patients available for analysis is small. Moreover, the duration of follow-up period is intermediate and longer follow-up is needed. At the available 3 years follow-up, the TIND implantation is safe, effective, and well-tolerated. The extended follow-up of the first and only available cohort of patients who underwent TIND for LUTS related to BPH corroborated previous literature findings. These researchers stated that further studies are needed to evaluate the durability of TIND outcomes over a longer follow-up, to better define the indications of this approach, and to demonstrate the advantages of second-generation device over the first.
Furthermore, UpToDate reviews on “Lower urinary tract symptoms in men” and “Transurethral procedures for treating benign prostatic hyperplasia” do not mention temporary implantable nitinol device as a therapeutic option.
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What Are The Side Effects
Once youre home, you may experience mild burning sensation during urination for a couple of weeks. This can be managed with mild pain medication. Patients can resume their normal activities once approved by their doctor.
Visit our Aquablation Therapy page for more information about the procedure, recovery, and side effects.
Description Of Procedure Or Service:
Benign prostatic hyperplasia 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 and older.1, BPH 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 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.
BPH 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.
For information regarding UroLift, please refer to medical policy #610: Prostatic Urethral Lift.
This evidence review has been updated regularly with search of the MEDLINE database. Most recently, the literature was reviewed through April 21, 2022.
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Why Is The Aquabeam Robotic Surgery Better
Aquablation therapy is a one-of-a-kind procedure. It is the only procedure that uses a heat-free waterjet controlled by robotic technology to remove prostate tissue and combines a camera with ultrasound imaging, giving the surgeon the ability to see the entire prostate in real time. As a result, Aquablation therapy is precise, consistent and predictable and provides long-term relief no matter how large your prostate is. It has a very low rate of irreversible complicationsincontinence, ejaculatory dysfunction, erectile dysfunction.1,2
Risks Of A Transurethral Needle Ablation
Although TUNA is a relatively safe procedure, complications can occur. Complications may include:
- Chronic inflammation of the prostate, which could cause painful urination or frequent need to urinate
- Difficulty urinating for a few days after the procedure
- Urinary tract infection
- Erectile dysfunction, while rare, can occur
- Need to be treated again
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Answers To Your Questions About Aquablation Therapy
The challenge with current treatment options is that while they may provide BPH symptom relief, they often force men to compromise in some way. Aquablation therapy is different as it provides long-lasting relief with low rates of complications.1,2
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Transperineal Laser Ablation Of The Prostate Or Transperineal Percutaneous Laser Ablation Including Imaging Guidance
Transperineal percutaneous laser ablation involves placing the patient in the lithotomy position on a treatment couch with a three-cavity urethral catheter insertion with the patient undergoing routine disinfection and draping before surgery. The procedure is performed under local anesthesia in the perineal region with lidocaine. Insertion of the optical fiber inside the prostate under transrectal ultrasound guidance. The main aim of treatment is to deliver 1,800 J of energy for the first ablation but is dependent on prostate size. At the close of treatment, 8 mg of dexamethasone can be given intravenously for anti-edema and anti-inflammatory reactions .
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Aquablation Therapy For Enlarged Prostate
Aquablation is a relatively new, FDA approved procedure for the treatment of Benign Prostate Hyperplasia . Its unique because it utilizes the AquaBeam Robotic System to deliver a heat-free waterjet to remove prostate tissue overgrowth. In addition, its an effective option for men with any size prostate . This procedure also features a cystoscope camera and transrectal ultrasound imaging to allow the surgeon to view the entire prostate real time during treatment.
Cms National Coverage Policy
This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations or payment policy rules and regulations for Transurethral Waterjet Ablation of the Prostate. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Transurethral Waterjet Ablation of the Prostateand must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals published on the CMS Web site:
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
- Chapter 14, Section 10 Coverage of Medical Devices
- CMS IOM Publication 100-04, Medicare Claims Processing Manual,
- Chapter 23, Section 30 Services paid under the Medicare Physicians Fee Schedule
Social Security Act Standard References:
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Cpt Codes Covered If Selection Criteria Are Met:
0421T Transurethral waterjet ablation of prostate, including control of post-operative bleeding, including ultrasound guidance, complete 52282 Cystourethroscopy, with insertion of permanent urethral stent 52441 Cystourethroscopy, with insertion of permanent adjustable transprostatic implant single implant 52442 each additional permanent adjustable transprostatic implant 52450 Transurethral incision of prostate 52601 Transurethral electrosurgical resection of prostate, including control of postoperative bleeding, complete 52647 Laser coagulation of prostate, including control of postoperative bleeding, complete 52648 Laser vaporization of prostate, including control of postoperative bleeding, complete 52649 Laser enucleation of the prostate with morcellation, including control of postoperative bleeding, complete 53850 Transurethral destruction of the prostate tissue by microwave thermotherapy 53854 Transurethral destruction of prostate tissue by radiofrequency generated water vapor thermotherapy
Practice Guidelines And Position Statements
American Urological Association
In 2021, the American Urological Association published guidelines on the surgical evaluation and treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia and included the following recommendations related to the interventions included in this evidence review:
Water vapor thermal therapy should be considered as a treatment option for patients with LUTS/BPH provided prostate volume is 30 to 80 cc.
- Water vapor thermal therapy may be offered as a treatment option to eligible patients who desire preservation of erectile and ejaculatory function.
- Robotic waterjet treatment may be offered as a treatment option to patients with LUTS/BPH provided prostate volume is 30 to 80 cc.
National Institute for Health and Care Excellence
In 2020, the National Institute for Health and Care Excellence issued the following guidance on Rezum for treatment of LUTS secondary to BPH:
“Evidence supports the case for adopting Rezum for treating lower urinary tract symptoms caused by benign prostatic hyperplasia in the NHS. Rezum relieves LUTS and improves quality of life.”
“Rezum is a minimally invasive procedure. It should be considered as a treatment option for people with:
- moderate to severe LUTS and
- a moderately enlarged prostate .”
In 2018, NICE issued the following guidance on transurethral water jet ablation for LUTS caused by BPH:
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What Are The Contraindications Of Transurethral Needle Ablation
The transurethral needle ablation should not be performed under the following circumstances:
At the time of urinary tract infections, the procedure should not be done as the risk of sepsis increases.
The person has a neurogenic bladder, a condition wherein control over the urinary bladder is lost.
Narrowing of the urethra or urethral stricture makes the insertion of the instrument difficult.
A patient who will be unable to survive the next 24 hours without surgery.
Patients on anticoagulants should not undergo the procedure as it increases the risk of bleeding. The drugs need to be stopped ten days before surgery.
Prostate cancer or urinary bladder cancer has been diagnosed clinically and radiographically.
The length of the prostate gland is less than 34 millimeters.
Patients who have undergone prostatic therapy previously.
Presence of penile implants and cardiac pacemakers.