PuraStat for Enlarged Prostate
(RAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether PuraStat, a hemostatic agent, can reduce bleeding after Aquablation, a procedure for treating symptoms of an enlarged prostate. The primary aim is to determine if PuraStat can minimize post-surgery bleeding, allowing patients to go home the same day. Men scheduled for Aquablation due to urinary problems from a non-cancerous enlarged prostate may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that PuraStat is safe for use following Aquablation?
Research has shown that PuraStat is generally well-tolerated by patients with an enlarged prostate. In one study, PuraStat had manageable side effects for those experiencing blood in urine and other urinary symptoms due to benign prostatic hyperplasia (BPH). Although the specific side effects were not listed, the study suggested that PuraStat is safe to use in this context. As this is a Phase 2 trial, early evidence indicates that PuraStat is safe enough for continued testing. However, further research is needed to confirm these results and ensure its safety for all patients.12345
Why do researchers think this study treatment might be promising?
PuraStat is unique because it introduces a novel approach to managing enlarged prostates, specifically targeting post-surgical bleeding. Unlike traditional treatments for benign prostatic hyperplasia (BPH) that rely on medications or surgical procedures alone, PuraStat is a hemostatic agent applied directly to the surgical site after an Aquablation procedure. This gel-like substance aids in sealing blood vessels, potentially reducing bleeding and promoting faster recovery. Researchers are excited because this method could lead to fewer complications and quicker recovery times for patients.
What evidence suggests that PuraStat is effective for reducing hematuria after Aquablation?
Research shows that PuraStat is often used to control bleeding after surgery. Past studies found PuraStat promising in reducing bleeding during and after operations. It creates a protective gel layer that seals wounds and stops bleeding. Although specific data for its use in enlarged prostate surgery is limited, early results suggest PuraStat can effectively manage bleeding. In this trial, participants undergoing Aquablation for an enlarged prostate will receive PuraStat to potentially reduce blood in the urine, leading to faster recovery and earlier discharge from the hospital.56789
Who Is on the Research Team?
Christopher Kelly, MD
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for men undergoing Aquablation therapy to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate. Participants must be willing to sign consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Aquablation procedure followed by the application of PuraStat to assess reduction of hematuria
Follow-up
Participants are monitored for post-operative hematuria and discharge criteria
What Are the Treatments Tested in This Trial?
Interventions
- PuraStat
Trial Overview
The study is testing PuraStat, a product used after the Aquablation procedure, aiming to reduce blood in urine (hematuria) and potentially allow patients to go home the same day.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Following the Aquablation procedure for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), the surgeon will deliver the PuraStat to the prostatic fossa through the cystoscope sheath into the prostate urethra resection bed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
Citations
Benign Prostatic Hyperplasia - StatPearls - NCBI Bookshelf
The treatment diminishes the prostate size by about 30% over time, and this reduction is localized to the obstructing lobes[148]. Unlike prostatic lift ...
2.
auanet.org
auanet.org/guidelines-and-quality/guidelines/benign-prostatic-hyperplasia-(bph)-guidelineBenign Prostatic Hyperplasia (BPH) Guideline
This difference in activity leads to a reduction in serum levels of DHT by approximately 70% with finasteride, compared to approximately 95% with dutasteride. ...
A comprehensive analysis of clinical, quality of life, and cost ...
This study evaluated the clinical and cost-effectiveness outcomes of CT, PUL, WVTT, PVP, and TURP for men experiencing moderate-to-severe LUTS ...
Trends and Perioperative Outcomes of Surgical Treatments ...
This study provides comprehensive real-world evidence on the perioperative outcomes and evolving trends of surgical treatments for benign prostatic hyperplasia ...
Benign Prostatic Hyperplasia: Rapid Evidence Review
This article provides a review of the available patient-oriented evidence to evaluate and manage lower urinary tract symptoms from BPH.
PuraStat for Enlarged Prostate (RAD Trial)
... PuraStat will have tolerable side effects & efficacy for patients with Enlarged Prostate, Hematuria, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia ...
Long-term Consequences of Medical Therapy for Benign ...
Until recently, medical therapy for BPH has been thought to be both safe and effective. However, new studies have shown that some of these medications can have ...
Safety and Efficacy Study for the Treatment of BPH ...
To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH). Detailed ...
Efficacy and Safety of High-Frequency Irreversible ...
This study is the first to report H-FIRE ablation as a novel treatment approach for BPH, showing satisfactory safety and operability.
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