CAC Meeting Agenda, Key Questions for Discussion, and Bibliography: Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia

The purpose of the meeting is to obtain advice from Contractor Advisory Committee (CAC) members and subject matter experts (SMEs) regarding the strength of published evidence on the Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia.

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Agenda

2-4 p.m. CT

  1. Welcome and Introduction
    • Facilitator: Dr. Laurence Clark, MD, FACP
  2. Key Questions and Discussion
    • CAC Members, Invited Subject Matter Experts, Contractor Medical Directors
  3. Closing Remarks and Adjournment

Key Questions for Discussion

General Questions

  1. Roehrborn, Teplitsky and Das in an August 2019 review state "critically, in head to head comparison with TURP, Aquablation has equivalent objective results with much shorter resection times and significantly fewer sexual side effects." Do you concur with this general statement?
  2. In the same review, the authors provide a cautionary statement, acknowledging literature reporting of trial data of essentially one year. Do you have concern over the long term durability of results?
  3. There is one study that reports a head to head trial including effectiveness and side effects with TURP, are there any studies providing a head to head comparison with other Minimally Invasive Therapies for BPH? Corollary question: do you classify Aquablation as a MIST, or does the use of general anesthesia vs. spinal anesthesia make it a "more invasive" procedure?
  4. In the general acceptance of this technology by NICE, there is a reference to "special arrangements." Does this imply uncertainties about safety and efficacy?
  5. Does the WATER II study define a specific role for this technology in the treatment of symptomatic patients with larger prostates (i.e. 80-150gms)?

Questions with Evidence Analysis- Evidence Rating 1-5, 1- lack of supporting evidence-better evidence is likely to change confidence, 3-moderate evidence-better evidence could change confidence, 5- strong evidence- further research is unlikely to change confidence

  1. Rate the evidence on Waterjet technology in terms of reduction of LUTS due to BPH with prostates less than 80 gm.
  2. Rate the evidence on Waterjet technology in terms of safety with prostates less than 80 gm.
  3. Rate the evidence on Waterjet technology in terms of reduction of sexual side effects.
  4. Rate the evidence on retreatment needs with this technology.
  5. Rate the evidence on Waterjet technology being non-inferior to TURP
  6. Rate the evidence on Waterjet technology in terms of reduction of LUTS due to BPH with prostates greater than 80 gm.
  7. Rate the evidence on Waterjet technology in terms of safety for prostates 80-150 gm.
  8. Rate the evidence on Waterjet technology compared to non-TURP procedures for prostates less than 80 gm. And 80-150 gm, respectively

Approval process question: This technology combines a computer limited area of resection, robotic execution, and high-velocity saline jet, and is FDA-cleared

Bibliography

Suggested Reading for Fluid Jet System in the Treatment of Benign Prostatic Hyperplasia Panelists (please feel free to suggest additional articles or more recent substitutions)

  1. Gilling, P., et al, Aquablation - image-guided robot-assisted waterjet ablation of the prostate: initial clinical experience. BJU International, 2016. 117(6): p. 923-9.
  2. Gilling, P., P. Anderson, and A. Tan, Aquablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: 1-Year Results. Journal of Urology, 2017. 197(6): p. 1565-1572.
  3. Gilling, P., P. Anderson, and A. Tan, AQUABLATION OF THE PROSTATE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA: TWO-YEAR RESULTS: PD23-11. Journal of Urology, 2017. 197(4)(Supplement): p. e451.
  4. Gilling, P., et al., WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation vs. Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia. Journal of Urology, 2018. 199(5): p. 1252-1261.
  5. Gilling, P., et al., Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained. 2019. 36(6): p. 1326-1336.
  6. Gilling, P., et al., MID-TERM RESULTS USING AQUABLATION, AN IMAGE GUIDED ROBOT-ASSISTED WATER JET ABLATION OF THE PROSTATE, FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH).: PD21-06. Journal of Urology, 2016. 195(4)(Supplement): p. e458.
  7. Gilling, P.J., et al., Randomized Controlled Trial of Aquablation versus Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia: One-year Outcomes. Urology, 2019. 125: p. 169-173.
  8. Giulio, R., et al., "Aquabeam® System" for benign prostatic hyperplasia and LUTS: birth of a new era. A systematic review of functional and sexual outcome and adverse events of the technique. 2019: p. 1.
  9. Hwang, E.C., et al., Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. Cochrane Database of Systematic Reviews, 2019. 2: p. CD013143.
  10. Harris E. Foster, M.M.J.B., MD; Philipp Dahm, MD; Manhar C. Gandhi, MD; Steven A. Kaplan, MD; Tobias S. Kohler, MD; Lori B. Lerner, MD; Deb J. Lightner, MD; J. Kellogg Parsons, MD; Claus G. Roehrborn, MD; Charles Welliver, MD; Timothy J. Wilt, MD; Kevin T. McVary, MD Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELIN. May 2019; Available from: https://auau.auanet.org/content/v02-01-prostate-aquablation-novel-image-guided-robot-assisted-prostate-ablation-using-water.
  11. Bhojani, N., et al., Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology, 2019. 129: p. 1-7.
  12. Desai, M., et al., Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU International, 2019. 08: p. 08.
  13. NICE. Transurethral water jet ablation for lower urinary tract symptoms caused by benign prostatic hyperplasia. accessed 8/1/2019]; Available from: https://www.nice.org.uk/Guidance/IPG629.

 

Last Updated Oct 29 , 2019