Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Lower Urinary Tract Symptoms (LUTS), AQUABEAM, Aquablation, Benign Prostatic Hyperplasia (BPH)
Brief 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.
Interventions
DEVICEAquablation
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.
Sponsors
PROCEPT BioRobotics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aquablation Procedure Aquablation: To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system. | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 60 Months Follow Up | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Aquablation Procedure |
|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 6.6 |
| Body mass index | 28.4 kg/m^2 STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| International Prostate Symptom Score (IPSS) | 23.2 score on a scale STANDARD_DEVIATION 6.3 |
| Prostate size (TRUS) | 107.4 cc STANDARD_DEVIATION 22.1 |
| Race/Ethnicity, Customized Race Asian | 5 Participants |
| Race/Ethnicity, Customized Race Black | 6 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race White | 88 Participants |
| Region of Enrollment Canada | 19 participants |
| Region of Enrollment United States | 82 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 82 / 101 |
| serious Total, serious adverse events | 18 / 101 |
Outcome results
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.
Time frame: 3 months post-treatment
Population: The number of participants analyzed for this outcome measure consist of the participants who completed the IPSS questionnaire at 3 months post-treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aquablation Procedure | Change in Total International Prostate Symptom Score (IPSS) Score at 3 Months as Compared to Baseline | -16.5 score on a scale |
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.
Time frame: 3 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aquablation Procedure | Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment | 45.5 percentage |
Post Hoc
Change in Total International Prostate Symptom Score (IPSS) Score at 60 Months as Compared to Baseline
The change in total IPSS score at 60 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.
Time frame: 60 months post-treatment