Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Benign Prostatic Hyperplasia (BPH) Clinical Trial

— WATERII  

Official title:

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123250
• Other study ID #: TP0124
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: December 20, 2022

Study information

• Verified date: June 2023
• Source: PROCEPT BioRobotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) with prostate volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to collect long-term clinical data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 20, 2022
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Aquablation
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.

Locations

Country	Name	City	State
Canada	Université de Montréal	Montréal	Quebec
Canada	University of Toronto-University Health Network	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
United States	Albany Medical College	Albany	New York
United States	University of Vermont	Burlington	Vermont
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Tibor Rubin VA Medical Center	Long Beach	California
United States	University of Southern California, Institute of Urology	Los Angeles	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Adult & Pediatrics Urology	Omaha	Nebraska
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Virginia Urology	Richmond	Virginia
United States	San Diego Clinical Trials	San Diego	California
United States	Urology of Virginia	Virginia Beach	Virginia
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
PROCEPT BioRobotics

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 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.	3 months post-treatment
Primary	Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline	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.	3 months post-treatment