Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge

Endeavor Health50 enrolled

Overview

Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

BPH (Benign Prostatic Hyperplasia)BPH With Symptomatic Lower Urinary Tract Symptoms

Interventions

PuraStat hydrogel and the syringeDEVICE

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Glenbrook Hospital- Endeavor Health

Glenview, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

Hematuria grade at 1-3 hours postop in the PACU

Grade the amount of blood present 1-3 hours after surgery Scale zero through Five

Time frame: 1 to 3 hours post procedure

Secondary Outcomes

Percentage of patients discharged on the same day

Examine whether the device helps recover more quickly and be discharged the same day, which currently happens in only 1% of cases.

Time frame: Postoperative Week 1

Patient Reported Outcome Measure IPSS questionnaire

International Prostate Symptom Score (IPSS), Min 0 Max 35 (Worst symptoms)

Time frame: From Enrollment to 30 days post procedure

Patient Reported Outcome Measures LURN SI-29 questionnaire

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

Time frame: From Enrollment to 30 days post procedure

Patient Reported Outcome Measures SHIM questionnaire

Sexual health inventory for men, Min 1 (Worst Sexual health) Max 25 ( Best Sexual Health)

Time frame: From Enrollment to 30 days post procedure

Patient Reported Outcome Measures MSHQ-EjD questionnaire

Male Sexual Health Questionnaire - Ejaculatory Dysfunction, Min 1 ( Worst) Max 15 ( Best)

Time frame: From Enrollment to 30 days post procedure

Patient Reported Outcome Measures Dysuria questionnaire

Difficult urination, Min 0 Max 5 (Worst)

Central Contacts

Pooja Research Manager, MS MHA

CONTACT

847-503-34280 PTalaty@northshore.org

Data from ClinicalTrials.gov

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