Benign Prostatic Hyperplasia, Hematuria, Lower Urinary Tract Symptoms
Conditions
Brief summary
This is a pilot proof of concept single-arm study using PuraStat following Aquablation procedure to assess reduction of hematuria to allow for same day discharge. The primary objective is to assess how PuraStat affects post-operative hematuria following Aquablation. The secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (Grade 0 and Grade I).
Interventions
DEVICEPuraStat
Sterile gel composed of synthetic peptide and sterile water; provided as a prefilled syringe. The will be applied to the inside of the prostate to help stop bleeding following Aquablation.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
• Any man undergoing Aquablation for LUTS due to BPH
Exclusion criteria
• Unwilling to sign consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients Discharged the Same Day as Aquablation | Day 1 (Operative Visit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Post-Operation Hematuria Grade | Day 1 (Up to Hour 3 Post-Op) | The mean hematuria grade noticed 1-3 hours post procedure. |
| Percentage of Patients who Experience Dysuria during Follow-Up | Up to Week 4 Post-Operation | — |
Countries
United States
Contacts
CONTACTMajlinda Tafa, MD
CONTACTChristopher Kelly, MD
PRINCIPAL_INVESTIGATORChristopher Kelly, MD
NYU Langone Health
Outcome results
None listed