Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Lower Urinary Tract Symptoms (LUTS)
Brief summary
A prospective multicenter randomized blinded study comparing Aquablation of the prostate with the AQUABEAM System and TURP for the treatment of Lower Urinary Tract Symptoms (LUTS). The primary endpoints for safety and effectiveness were measured at 3 and 6 months, respectively, and subjects were followed out to 5 years to collect long-term clinical data.
Interventions
DEVICEAQUABEAM System
The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue.
Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)
Sponsors
PROCEPT BioRobotics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
All study subjects and the study site follow-up team are blinded to the assigned treatment until the year 3 follow-up.
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. * Age from 45 to 80 years. * Subject has medical record documentation of a prostate volume between 30mL and 80mL (inclusive) by transrectal ultrasound (TRUS). (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is between 30mL and 80mL, it may be used for the inclusion/
Exclusion criteria
.) * Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit. * Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15mL/s. (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 125mL, and the Qmax is less than 15mL/s it may be used for the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability) | Three months post-treatment | The primary safety endpoint is the proportion 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. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment. Results are presented as a percentage rounded to the whole number. |
| Change Score of IPSS Questionnaire Between Baseline and 6 Months | Six months post-treatment | The primary effectiveness endpoint is the IPSS change score from baseline to 6 months. International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months | 60 months following original surgical intervention | International Prostate Symptom Score Quality of Life (IPSS-QoL) sub-score. Score range is from 0 to 6, with a low score associated with more favorable outcomes. |
| Long-term Effectiveness as Measured by International Prostate Symptom Score (IPSS) at 60 Months | 60 months following original surgical intervention | Change score of International Prostate Symptom Score (IPSS) at 60 months as compared to baseline. Score range is from 0 to 35, with a low score associated with more favorable outcomes. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline. |
| Change in Post-void Residual (PVR) at 60 Months From Baseline | 60 months following original surgical intervention | Change in Post-void residual (PVR) urine test at 60 Months from Baseline. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline. |
| Change in Maximum Urinary Flow Rate (Qmax) at 60 Months From Baseline | 60 months following original surgical intervention | Change in Uroflowmetry measurement of voided urine (in milliliters) per unit of time (in seconds) at 60 Months from Baseline. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline. |
| International Prostate Symptom Score (IPSS) at 60 Months | 60 months following original surgical intervention | International Prostate Symptom Score (IPSS) at 60 months. Score range is from 0 to 35, with a low score associated with more favorable outcomes. |
Countries
Australia, New Zealand, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment AQUABEAM system
The AQUABEAM system, a personalized image-guided tissue removal system, utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue. | 117 |
| Active Comparator Transurethral Resection of the Prostate (TURP)
Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH) | 67 |
| Total | 184 |
Baseline characteristics
| Characteristic | Total | Treatment | Active Comparator |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 7.3 | 66.0 years STANDARD_DEVIATION 7.3 | 65.8 years STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 178 Participants | 114 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized NA | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 168 Participants | 109 Participants | 59 Participants |
| Region of Enrollment Australia | 21 Participants | 13 Participants | 8 Participants |
| Region of Enrollment New Zealand | 20 Participants | 11 Participants | 9 Participants |
| Region of Enrollment United Kingdom | 50 Participants | 32 Participants | 18 Participants |
| Region of Enrollment United States | 93 Participants | 61 Participants | 32 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 184 Participants | 117 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 116 | 1 / 65 |
| other Total, other adverse events | 75 / 116 | 53 / 65 |
| serious Total, serious adverse events | 24 / 116 | 14 / 65 |
Outcome results
Primary
Change Score of IPSS Questionnaire Between Baseline and 6 Months
The primary effectiveness endpoint is the IPSS change score from baseline to 6 months. International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome.
Time frame: Six months post-treatment
Population: The variation between the overall number of participants analyzed for this outcome and the completed number on the participant flow at this follow-up is due to this specific outcome assessment not being done by all participants who completed this follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change Score of IPSS Questionnaire Between Baseline and 6 Months | -16.9 score on a scale | Standard Deviation 6.6 |
| Active Comparator | Change Score of IPSS Questionnaire Between Baseline and 6 Months | -15.1 score on a scale | Standard Deviation 7.9 |
Primary
Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
The primary safety endpoint is the proportion 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. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment. Results are presented as a percentage rounded to the whole number.
Time frame: Three months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability) | 26 percentage of participants |
| Active Comparator | Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability) | 42 percentage of participants |
Other Pre-specified
Change in Maximum Urinary Flow Rate (Qmax) at 60 Months From Baseline
Change in Uroflowmetry measurement of voided urine (in milliliters) per unit of time (in seconds) at 60 Months from Baseline. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline.
Time frame: 60 months following original surgical intervention
Population: The variation between the overall number of participants analyzed for this outcome and the completed number on the participant flow at this follow-up is due to this specific outcome assessment not being done by all participants who completed this follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Maximum Urinary Flow Rate (Qmax) at 60 Months From Baseline | 8.7 mL/s | Standard Deviation 9.1 |
| Active Comparator | Change in Maximum Urinary Flow Rate (Qmax) at 60 Months From Baseline | 6.3 mL/s | Standard Deviation 7.5 |
Other Pre-specified
Change in Post-void Residual (PVR) at 60 Months From Baseline
Change in Post-void residual (PVR) urine test at 60 Months from Baseline. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline.
Time frame: 60 months following original surgical intervention
Population: The variation between the overall number of participants analyzed for this outcome and the completed number on the participant flow at this follow-up is due to this specific outcome assessment not being done by all participants who completed this follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Post-void Residual (PVR) at 60 Months From Baseline | -62 mL | Standard Deviation 86 |
| Active Comparator | Change in Post-void Residual (PVR) at 60 Months From Baseline | -82 mL | Standard Deviation 94 |
Other Pre-specified
International Prostate Symptom Score (IPSS) at 60 Months
International Prostate Symptom Score (IPSS) at 60 months. Score range is from 0 to 35, with a low score associated with more favorable outcomes.
Time frame: 60 months following original surgical intervention
Population: The variation between the overall number of participants analyzed for this outcome and the completed number on the participant flow at this follow-up is due to this specific outcome assessment not being done by all participants who completed this follow-up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | International Prostate Symptom Score (IPSS) at 60 Months | 5.5 score on a scale |
| Active Comparator | International Prostate Symptom Score (IPSS) at 60 Months | 6 score on a scale |
Other Pre-specified
International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months
International Prostate Symptom Score Quality of Life (IPSS-QoL) sub-score. Score range is from 0 to 6, with a low score associated with more favorable outcomes.
Time frame: 60 months following original surgical intervention
Population: The variation between the overall number of participants analyzed for this outcome and the completed number on the participant flow at this follow-up is due to this specific outcome assessment not being done by all participants who completed this follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months | 1.6 score on a scale | Standard Deviation 1.4 |
| Active Comparator | International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months | 1.6 score on a scale | Standard Deviation 1.5 |
Other Pre-specified
Long-term Effectiveness as Measured by International Prostate Symptom Score (IPSS) at 60 Months
Change score of International Prostate Symptom Score (IPSS) at 60 months as compared to baseline. Score range is from 0 to 35, with a low score associated with more favorable outcomes. Change score is calculated from two time points as the value at the 60 months point minus the value at the baseline.
Time frame: 60 months following original surgical intervention
Population: The variation between the overall number of participants analyzed for this outcome and the completed number on the participant flow at this follow-up is due to this specific outcome assessment not being done by all participants who completed this follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Long-term Effectiveness as Measured by International Prostate Symptom Score (IPSS) at 60 Months | -15.1 change in score on a scale | Standard Deviation 6.6 |
| Active Comparator | Long-term Effectiveness as Measured by International Prostate Symptom Score (IPSS) at 60 Months | -13.2 change in score on a scale | Standard Deviation 8.2 |