Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

• Aquablation (Device): The procedure is performed with the AquaBeam System. It is designed to utilize a high-velocity sterile saline waterjet as the cutting medium, which is projected through a nozzle positioned within the prostatic urethra. The Aquablation procedure integrates real-time ultrasound imaging with a robotically executed surgeon guided high-velocity waterjet to resect prostate tissue.

Primary outcomes

• Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment [3 months post-treatment]: The percentage of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment.
• Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline [3 months post-treatment]: The change in total IPSS score at 3 months as compared to baseline. The objective of the International Prostate Symptom Score (IPSS) is to capture the severity of urinary symptoms related to benign prostatic hyperplasia IPSS ranges from 0 to 35. A higher score indicates a worse outcome.

Sex: Male, ages: 45 Years to 80 Years

Inclusion Criteria:

* Male age 45-80 years.
* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
* Subject has an IPSS score greater than or equal to 12.
* Maximum urinary flow rate (Qmax) less than 15mL/s.
* Serum creatinine < 2 mg/dL within 30 days of surgery.
* History of inadequate or failed response, contraindication, or refusal to medical therapy.
* Prostate size ≥ 80 mL and ≤ 150 mL as measured by TRUS.
* Patient is mentally capable and willing to sign a study-specific informed consent form.

Exclusion Criteria:

* BMI ≥ 42.
* Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
* Participants using systemic immune-suppressants including corticosteroids (except inhalants); unable to withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) prior to treatment per standard or care except for low dose aspirin (e.g. less than or equal to 100mg).
* Contraindication to both general and spinal anesthesia.
* Any severe illness that would prevent complete study participation or confound study results.
* History of prostate cancer or current/suspected bladder cancer. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if PSA is above acceptable thresholds.
* History of actively treated bladder cancer within the past two (2) years.
* Clinically significant bladder calculus or bladder diverticulum (e.g., pouch size >20% of full bladder size).
* Active infection, including urinary tract infection or prostatitis.
* Urinary catheter use daily for 90 or more days consecutively.
* Previous urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis.
* Ever been diagnosed with a clinically significant urethral stricture or meatal stenosis, or bladder neck contracture.
* Known damage to external urinary sphincter.
* Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of informed consent.
* Participants using anticholinergics specifically for bladder problems. Use of medications with anticholinergic properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
* Subject is unwilling to accept a transfusion should one be required.

Participant flow

Outcome results

• Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment (Primary), Number, percentage: Aquablation Procedure 45.5
• Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline (Primary), Mean, score on a scale: Aquablation Procedure -16.5 (-18.1 to -14.8)
• Change in Total International Prostate Symptom Score (IPSS) Score at 60 Months as Compared to Baseline (Post hoc)

Adverse events

Time frame: 2 years

Serious adverse events by term

Other adverse events by term

Limitations and caveats: The main limitation is that the trial is a single-arm study with a pre-specified performance goal and not randomized against another treatment arm.

• Bhojani N, Bidair M, Kramolowsky E, Desai M, Doumanian L, Zorn KC, Elterman D, Kaufman RP Jr, Eure G, Badlani G, Plante M, Uchio E, Gin G, Paterson R, So A, Roehrborn C, Motola J, Kaplan S, Humphreys M. Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results. J Urol. 2023 Jul;210(1):143-153. doi: 10.1097/JU.0000000000003483. Epub 2023 Apr 28. PMID 37115632
• Desai M, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Bhojani N. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial. BJU Int. 2019 Aug;124(2):321-328. doi: 10.1111/bju.14703. Epub 2019 Mar 29. PMID 30734990
• Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys MR, Roehrborn CG, Kaplan S, Motola J, Zorn KC. Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results. Can J Urol. 2020 Apr;27(2):10147-10153. PMID 32333733
• Desai M, Bidair M, Bhojani N, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP Jr, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Roehrborn C, Kaplan S, Motola J, Zorn KC. WATER II (80-150 mL) procedural outcomes. BJU Int. 2019 Jan;123(1):106-112. doi: 10.1111/bju.14360. Epub 2018 Jun 10. PMID 29694702
• Bhojani N, Bidair M, Zorn KC, Trainer A, Arther A, Kramolowsky E, Doumanian L, Elterman D, Kaufman RP, Lingeman J, Krambeck A, Eure G, Badlani G, Plante M, Uchio E, Gin G, Goldenberg L, Paterson R, So A, Humphreys M, Kaplan S, Motola J, Desai M, Roehrborn C. Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results. Urology. 2019 Jul;129:1-7. doi: 10.1016/j.urology.2019.04.029. Epub 2019 May 3. PMID 31059728
• Results publication: Chughtai B, Thomas D. Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60-150 cc). Adv Ther. 2018 Jun;35(6):832-838. doi: 10.1007/s12325-018-0722-0. Epub 2018 Jun 5. PMID 29873008

• Study Protocol (PDF, 2020-01-22)
• Statistical Analysis Plan (PDF, 2018-01-09)