BPH (Benign Prostatic Hyperplasia), BPH With Symptomatic Lower Urinary Tract Symptoms
Conditions
Keywords
PuraStat,Aquablation, BPH, Lower urinary tract symptoms
Brief summary
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure
Detailed description
This study will evaluate the safety and effectiveness of a device (PuraStat hydrogel and the syringe used to apply it - referred to as PuraStat, designed to help control bleeding after the subject's scheduled Aquablation procedure. To assess its effectiveness, investigators will take a picture of the color of your urethral Foley catheter and grade the amount of blood present 1-3 hours after surgery. Investigators will also examine whether the device helps subjects recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
Interventions
DEVICEPuraStat hydrogel and the syringe
PuraStat device is FDA-approved for other uses, such as gastrointestinal endoscopy and ENT (ear, nose, throat) procedures. Its use in this study for urology is investigational.
Sponsors
Endeavor Health
PROCEPT BioRobotics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
PuraStat and non PuraStat
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be undergoing Aquablation 2. Subject is willing to comply with protocol requirements
Exclusion criteria
1. Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal procedure 2. Known or suspected systemic or severe infection 3. Patient unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematuria grade at 1-3 hours postop in the PACU | 1 to 3 hours post procedure | Grade the amount of blood present 1-3 hours after surgery Scale zero through Five |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients discharged on the same day | Postoperative Week 1 | Examine whether the device helps recover more quickly and be discharged the same day, which currently happens in only 1% of cases. |
| Patient Reported Outcome Measure IPSS questionnaire | From Enrollment to 30 days post procedure | International Prostate Symptom Score (IPSS), Min 0 Max 35 (Worst symptoms) |
| Patient Reported Outcome Measures LURN SI-29 questionnaire | From Enrollment to 30 days post procedure | Lower Urinary Research Network Symptom Index-29. Max 100 (Worst Symptoms), Min 0 (Best Symptoms). Multiple health domains are being evaluated such as incontinence, pain, voiding, urgency, nocturia, frequency |
| Patient Reported Outcome Measures SHIM questionnaire | From Enrollment to 30 days post procedure | Sexual health inventory for men, Min 1 (Worst Sexual health) Max 25 ( Best Sexual Health) |
| Patient Reported Outcome Measures MSHQ-EjD questionnaire | From Enrollment to 30 days post procedure | Male Sexual Health Questionnaire - Ejaculatory Dysfunction, Min 1 ( Worst) Max 15 ( Best) |
| Patient Reported Outcome Measures Dysuria questionnaire | 30 days post procedure | Difficult urination, Min 0 Max 5 (Worst) |
Countries
United States
Contacts
CONTACTPooja Research Manager, MS MHA
STUDY_DIRECTORAlexander P Glaser, MD
Endeavor Health
Outcome results
None listed