Trial Outcomes & Findings for Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER) (NCT NCT02505919)
NCT ID: NCT02505919
Last Updated: 2023-07-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
Three months post-treatment
Results posted on
2023-07-03
Participant Flow
Participant milestones
| Measure |
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.
|
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)
|
|---|---|---|
|
Treatment
STARTED
|
116
|
65
|
|
Treatment
COMPLETED
|
116
|
65
|
|
Treatment
NOT COMPLETED
|
0
|
0
|
|
1 Week Follow-Up
STARTED
|
116
|
65
|
|
1 Week Follow-Up
COMPLETED
|
116
|
65
|
|
1 Week Follow-Up
NOT COMPLETED
|
0
|
0
|
|
1 Month Follow-Up
STARTED
|
116
|
65
|
|
1 Month Follow-Up
COMPLETED
|
116
|
65
|
|
1 Month Follow-Up
NOT COMPLETED
|
0
|
0
|
|
3 Months Follow-Up
STARTED
|
116
|
65
|
|
3 Months Follow-Up
COMPLETED
|
116
|
65
|
|
3 Months Follow-Up
NOT COMPLETED
|
0
|
0
|
|
6 Months Follow-Up
STARTED
|
116
|
65
|
|
6 Months Follow-Up
COMPLETED
|
116
|
63
|
|
6 Months Follow-Up
NOT COMPLETED
|
0
|
2
|
|
12 Months Follow-Up
STARTED
|
116
|
63
|
|
12 Months Follow-Up
COMPLETED
|
115
|
61
|
|
12 Months Follow-Up
NOT COMPLETED
|
1
|
2
|
|
24 Months Follow-Up
STARTED
|
115
|
61
|
|
24 Months Follow-Up
COMPLETED
|
112
|
60
|
|
24 Months Follow-Up
NOT COMPLETED
|
3
|
1
|
|
36 Months Follow-Up
STARTED
|
112
|
60
|
|
36 Months Follow-Up
COMPLETED
|
97
|
55
|
|
36 Months Follow-Up
NOT COMPLETED
|
15
|
5
|
|
60 Months Follow-Up
STARTED
|
97
|
55
|
|
60 Months Follow-Up
COMPLETED
|
58
|
32
|
|
60 Months Follow-Up
NOT COMPLETED
|
39
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)
Baseline characteristics by cohort
| Measure |
Treatment
n=117 Participants
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.
|
Active Comparator
n=67 Participants
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)
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
109 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NA
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
32 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three months post-treatmentThe 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.
Outcome measures
| Measure |
Treatment
n=116 Participants
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.
|
Active Comparator
n=65 Participants
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)
|
|---|---|---|
|
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
Interval 18.2 to 34.8
|
42 percentage of participants
Interval 29.4 to 54.4
|
PRIMARY outcome
Timeframe: Six months post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Treatment
n=114 Participants
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.
|
Active Comparator
n=62 Participants
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)
|
|---|---|---|
|
Change Score of IPSS Questionnaire Between Baseline and 6 Months
|
-16.9 score on a scale
Standard Deviation 6.6
|
-15.1 score on a scale
Standard Deviation 7.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 months following original surgical interventionPopulation: 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.
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.
Outcome measures
| Measure |
Treatment
n=58 Participants
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.
|
Active Comparator
n=31 Participants
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)
|
|---|---|---|
|
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
|
-13.2 change in score on a scale
Standard Deviation 8.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 months following original surgical interventionPopulation: 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.
International Prostate Symptom Score (IPSS) at 60 months. Score range is from 0 to 35, with a low score associated with more favorable outcomes.
Outcome measures
| Measure |
Treatment
n=58 Participants
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.
|
Active Comparator
n=31 Participants
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)
|
|---|---|---|
|
International Prostate Symptom Score (IPSS) at 60 Months
|
5.5 score on a scale
Interval 1.0 to 28.0
|
6 score on a scale
Interval 1.0 to 28.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 months following original surgical interventionPopulation: 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.
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.
Outcome measures
| Measure |
Treatment
n=58 Participants
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.
|
Active Comparator
n=31 Participants
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)
|
|---|---|---|
|
International Prostate Symptom Score Quality of Life (IPSS-QoL) at 60 Months
|
1.6 score on a scale
Standard Deviation 1.4
|
1.6 score on a scale
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 months following original surgical interventionPopulation: 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.
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.
Outcome measures
| Measure |
Treatment
n=41 Participants
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.
|
Active Comparator
n=26 Participants
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)
|
|---|---|---|
|
Change in Maximum Urinary Flow Rate (Qmax) at 60 Months From Baseline
|
8.7 mL/s
Standard Deviation 9.1
|
6.3 mL/s
Standard Deviation 7.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 months following original surgical interventionPopulation: 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.
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.
Outcome measures
| Measure |
Treatment
n=41 Participants
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.
|
Active Comparator
n=25 Participants
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)
|
|---|---|---|
|
Change in Post-void Residual (PVR) at 60 Months From Baseline
|
-62 mL
Standard Deviation 86
|
-82 mL
Standard Deviation 94
|
Adverse Events
Treatment
Serious events: 24 serious events
Other events: 75 other events
Deaths: 4 deaths
Active Comparator
Serious events: 14 serious events
Other events: 53 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment
n=116 participants at risk
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.
|
Active Comparator
n=65 participants at risk
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)
|
|---|---|---|
|
Renal and urinary disorders
Bladder neck contracture (non-procedure-related)
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Bleeding
|
3.4%
4/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
6.2%
4/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Cardiac disorders
Cardiac (non-procedure-related)
|
3.4%
4/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
3.1%
2/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
General disorders
Non-urologic
|
2.6%
3/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
0.00%
0/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
General disorders
Other bleeding (non-procedure-related)
|
1.7%
2/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
0.00%
0/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Pain
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
0.00%
0/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Infections and infestations
Penial infection (non-procedure-related)
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer (non-procedure-related)
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Stricture or adhesions
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Stricture or adhesions (non-procedure-related)
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
3/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
3.1%
2/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary retention (non-procedure-related)
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary tract infection (non-procedure-related)
|
1.7%
2/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
0.00%
0/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary tract stones (non-procedure-related)
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary urgency/frequency/difficulty/leakage
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
0.00%
0/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary urgency/frequency/difficulty/leakage (non-procedure-related)
|
4.3%
5/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
Other adverse events
| Measure |
Treatment
n=116 participants at risk
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.
|
Active Comparator
n=65 participants at risk
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)
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation (non-procedure-related)
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Bladder neck contracture
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Bladder neck contracture (non-procedure-related)
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Bladder pain/spasm
|
6.0%
7/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
4.6%
3/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Bleeding
|
10.3%
12/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
9.2%
6/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Bleeding (non-procedure-related)
|
4.3%
5/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
7.7%
5/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Reproductive system and breast disorders
Decreased libido
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Dysuria
|
12.1%
14/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
9.2%
6/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Dysuria (non-procedure-related)
|
3.4%
4/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Reproductive system and breast disorders
Erectile Dysfunction (non-procedure-related)
|
6.0%
7/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
9.2%
6/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Hydrocele
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Cardiac disorders
Hypertension (non-procedure-related)
|
2.6%
3/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
3.1%
2/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Cardiac disorders
Hypotension
|
2.6%
3/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
0.00%
0/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
General disorders
Non-urologic
|
13.8%
16/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
10.8%
7/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Overactive bladder (non-procedure-related)
|
4.3%
5/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
0.00%
0/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Pain
|
6.9%
8/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
6.2%
4/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Pain (non-procedure-related)
|
1.7%
2/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Penile disorder (non-procedure-related)
|
1.7%
2/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
0.00%
0/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Perineal swelling
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Infections and infestations
Prostatitis (non-procedure-related)
|
1.7%
2/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
3.1%
2/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Reproductive system and breast disorders
Retrograde ejaculation
|
6.9%
8/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
24.6%
16/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Reproductive system and breast disorders
Retrograde ejaculation (non-procedure-related)
|
4.3%
5/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
6.2%
4/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Rising PSA (non-procedure-related)
|
3.4%
4/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Reproductive system and breast disorders
Sexual dysfunction (non-procedure-related)
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Stricture or adhesions
|
1.7%
2/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Stricture or adhesions (non-procedure-related)
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
3.1%
2/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Swollen Testicles
|
0.00%
0/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urethral damage
|
0.86%
1/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary retention
|
6.9%
8/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
4.6%
3/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary retention (non-procedure-related)
|
3.4%
4/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
7.7%
5/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary tract infection
|
9.5%
11/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
7.7%
5/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary tract infection (non-procedure-related)
|
5.2%
6/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
6.2%
4/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary tract stones (non-procedure-related)
|
1.7%
2/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
1.5%
1/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary urgency/frequency/difficulty/leakage
|
7.8%
9/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
13.8%
9/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
|
Renal and urinary disorders
Urinary urgency/frequency/difficulty/leakage (non-procedure-related)
|
15.5%
18/116 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
21.5%
14/65 • 5 years
There were no device-related adverse events reported in the study, and there were no unanticipated procedure-related adverse events reported in the study. Of the adverse events resulting in mortality, none were procedure-related, device-related, or urological.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60