Design of Study
How many men were enrolled in the OPEN and HINATA study?
What is 178 and is 103 men?
OPEN- 178
HINATA- 103
Was cautery used in OPEN WATER?
What is Yes?
- In 19 (10.7%) cases, hemostasis was augmented with focal cautery, but (90%) post-operative hemostasis technique was robust catheter traction without electrocautery.
Transfusion Rate was 2.7%
What does 0-7, 8-19, and 20-55 correspond to in IPSS severity categories?
IPSS Scores
0-7= Mild
8-19= Moderate
20-35= Severe
What percentage from baseline did PSA reduce after 3 months in OPEN WATER.
What is 41.5%
-For subjects with a baseline PSA ≥2, the 3-month drop in PSA was 41.5%.
What was the primary objective of the HINATA study?
What is to evaluate safety, efficacy, and patient‑reported outcomes in Japanese men with BPH?
How many sites were involved in both OPEN WATER and HINATA?
What is 5?
Both Open Water and Hinata had 5 sites involved with the study.
Was cautery used in HINATA?
What is yes?
- For all patients Focal bladder neck cautery was used to induce hemostasis, and is consistently associated with a transfusion risk of <1% with the Elterman study.
What was the decrease in post-void residual volume at 12 months in OPEN WATER and 6 months in the HINATA?
What 108 mL/s to 61 at 12 months and 85.6 mL/s to 43.3 mL/s at 6 months
OPEN WATER- Post-void residual improved from 108 mL/s to 61mL/s cc at 12 months.
HINATA- Post-void residual volume improved from 85.6 mL/s to 43.3 mL/s at 6 months
What was the surgical retreatment rate at 6 months in the HINATA study?
0%
What was the primary objective of the OPEN WATER Study?
What is to show real-world safety and effectiveness from the use of Aquablation in a standard commercial setting for treating BPH?
Did physicians have experience to Aquablation in OPEN and HINATA?
What is yes and no?
-In Open Water, it involved surgeons with both high and low levels of experience with the Aquablation procedure.
-In Hinata, none had prior experience with the Aquablation procedure.
What percentage of patients underwent transfusion in the week following Aquablation in OPEN WATER and 6 months for HINATA?
What is 2.7 and <1%
- Five of 182 (2.7%) patients underwent transfusion in the week following Aquablation; 14 (7.9%) patients were taken back to the OR for postoperative hemostasis management.
What was the change from baseline IPSS in both OPEN WATER at 12 months and HINATA at 6 months.
What is 15.3 and 12.0?
OPEN WATER- IPSS decreased from 21.6 (severe) at baseline to 6.5 (mild) at the 12 month follow up. A 15.3 point improvement.
HINATA- IPSS decreased from 18.1 (moderate) baseline to to 6.1 (mild) at the 6 month follow up. A 12.0 point improvement.
What was the mean operative time for a 100cc prostate in OPEN Water?
What is 24 minutes?
-The mean operative time was 24 min, which is substantially lower than that observed for open prostatectomy (95 min), HoLEP (91 min), or PVP (93 min) in similarly sized prostates.
How would you respond to this scenario from a surgeon?
"I read in your study Open Water study that 5 patients underwent transfusions in the first week after the Aqublation. That's a bit concerning, can you tell me more about that?"
In our study 90% of the patients enlisted did not do any sort of cautery. Since then we have implemented a technique called FBNC, where has shown a <1% transfusion rate.
What percentage of men had a median lobe present in OPEN WATER?
What is 59%?
A middle lobe was present in 59% of cases; of these 72% had an intravesical component. 106 (59.6%) Intravesical component 77/106 (72.6%) .
How many patients reported incontinence in both OPEN WATER and HINATA?
What is 1 in OPEN WATER and 0 in HINATA?
What was the change from baseline Q-Max in both OPEN WATER at 12 months and Hinata at 6 months?
What is 11.2 and 7.2?
- Q-Max increased from 10 mL/s at baseline to 20.8 mL/s at month 12 (11.8cc increase)
- Q-Max increased from 8.3 mL/s at baseline to 15.5 mL/s at month 6. (7.2mL/s increase)
How many men at the end of OPEN WATER, got off medication?
What is 74?
-Eighty-two patients (46%) were taking medications for BPH preoperatively. By month 3, all but eight had stopped these medications.
I've heard from my partners, Aquablation is just for larger glands. Why are you telling me that I should try smaller than <80?
-The WATER study demonstrated Aquablation to be equivalent to TURP for prostates in this same size range in terms of efficacy and superior in terms of functional preservation. Unlike TURP, Aquablation achieves consistent results when applied to populations with larger prostates.
What was the mean baseline prostate volume in Open and Hinata?
What is 59 mL and 82.3 mL?
OPEN- 59 mL
HINATA- 82.3 mL
What percentage of patients preserved ejaculatory and erectile dysfunction in both OPEN WATER and HINATA?
What is 92% and 1% in OPEN? What is 100% and 100% in HINATA?
OPEN WATER- Fifteen patients (8%) reported ejaculatory dysfunction and one (1%) reported erectile dysfunction.
HINATA- There were no reports of erectile dysfunction or ejaculatory dysfunction.
What was the mean IPSS QOL changes from baseline to 12 months in OPEN WATER and 6 months for HINATA?
What is 1.4 and 3.1?
OPEN WATER- Mean IPSS QOL- scores improved from 4.7 at baseline to 1.4 at 12 months. (A 3.3 point improvement)
HINATA- Mean IPSS QOL- scores improved from 4.9 to 1.8 at 6 months. (A 3.1 point improvement)
What was the mean prostate volume at the 3 month follow up in OPEN WATER?
What is 35cc?
-Mean (SD) prostate size measured was 59 cc at the baseline and 35 cc at the follow-up, representing a 36% decrease in volume.
"Austin are you China?"
-Dylan
No
-Austin