Urolift for Enlarged Prostate
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the Urolift treatment can reduce urinary problems caused by prostate cancer radiation therapy. Urolift, a minimally invasive procedure, may help ease symptoms such as frequent urination and discomfort. The trial targets men with prostate cancer requiring radiation and an enlarged prostate (BPH). Ideal participants have been diagnosed with both prostate cancer and BPH but do not have certain urinary conditions or infections. Participants will undergo the Urolift procedure before starting radiation therapy. As an unphased trial, this study provides an opportunity to explore new ways to improve quality of life during cancer treatment.
What prior data suggests that Urolift is safe for reducing urinary side effects of SBRT?
Research has shown that the UroLift system is generally safe and effective for treating prostate problems. One study found that 92.2% of men experienced successful results over two years, with improved urine flow and reduced symptoms. Most side effects are mild and short-lived, including blood in the urine, discomfort during urination, and pelvic pain, which typically resolve quickly. The complication rate in hospitals was low, at just 3.4%. This evidence suggests that UroLift is a reliable and safe option for managing prostate conditions.12345
Why are researchers excited about this trial?
Unlike the standard treatments for prostate cancer and BPH, which often involve surgery, radiation, or medication, Urolift offers a less invasive option. Urolift is unique because it is a one-time, minimally invasive procedure that lifts and holds the enlarged prostate tissue out of the way, relieving urinary obstruction without cutting, heating, or removing tissue. Researchers are excited about Urolift because it has the potential to reduce urinary side effects typically associated with radiation therapy like SBRT, improving the quality of life for patients undergoing prostate cancer treatment.
What evidence suggests that Urolift might be an effective treatment for urinary side effects following SBRT?
Research has shown that the Urolift system effectively treats benign prostatic hyperplasia (BPH), an enlargement of the prostate. Studies have found that patients receiving Urolift implants often experience quick relief and improved urine flow. Most men report feeling "much" or "very much better" just one month after the procedure. Long-term results indicate a low need for additional surgery, with only about 13.6% of patients requiring retreatment over five years. In this trial, participants will receive a one-time administration of Urolift before SBRT (stereotactic body radiation therapy) for prostate cancer treatment, which may help reduce urinary symptoms even after prostate cancer treatments.678910
Who Is on the Research Team?
Bilal Chughtai, MD
Principal Investigator
Northwell Health
Are You a Good Fit for This Trial?
This trial is for men aged 40-99 with prostate cancer needing SBRT and also have an enlarged prostate (BPH). They must be able to consent, complete questionnaires, and be eligible for the Urolift procedure. People with certain urinary or nerve problems, infections, recent surgeries, or other major health issues cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time administration of Urolift prior to SBRT for prostate cancer treatment
Follow-up
Participants are monitored for changes in IPSS scores, medication usage, quality of life, sexual function, and pain symptoms
What Are the Treatments Tested in This Trial?
Interventions
- Urolift
Trial Overview
The study tests if having a Urolift procedure before receiving stereotactic body radiation therapy (SBRT) can reduce short-term and long-term urinary side effects in men with both BPH and prostate cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Weill Medical College of Cornell University
Lead Sponsor
NeoTract, Inc.
Industry Sponsor
Teleflex
Industry Sponsor
Citations
1.
investors.teleflex.com
investors.teleflex.com/news/news-details/2023/New-Data-Highlight-that-Early-Intervention-with-the-UroLift-System-Facilitates-Long-Term-Outcomes-for-BPH-Patients/default.aspxNew Data Highlight that Early Intervention with the UroLift ...
study results demonstrate UroLift® System durability with a surgical retreatment rate of about 2-3% per year and 13.6% total over 5 years.7 Most ...
2.
urolift.com
urolift.com/patients/about-us/press-releases/urolift-system-safety-efficacy-bph-treatmentNeoTract's UroLift® Prostate Implant Demonstrates Strong ...
Patients receiving the UroLift implants reported rapid symptomatic improvement, increased urinary flow rates, and preserved sexual function.
Comparison of Durability Between Rezum Water Vapor ...
UroLift demonstrated a higher reintervention rate of 8.93% versus 5.83% at the 3rd year and 10.75% versus 6.74% at the 5th year compared to the ...
How Effective Does A UroLift Procedure Actually Work?
Clinical studies show a 13.6% retreatment rate over five years, demonstrating long-term success. UroLift uses small implants to lift enlarged prostate tissue ...
5.
uhhospitals.org
uhhospitals.org/uh-research/find-clinical-trials-and-studies/clinical-trials-search/urolift-study-7040UroLift Study
The purpose of the study is to measure urinary symptoms and assess patient outcomes after a prostatic urethral lift procedure.
Published Data Demonstrate Sexual Function ...
Following the UroLift System procedure, patients experienced a significant improvement in erectile function (17% at 1 year and 21% at 2 years).
Efficacy and safety of prostatic urethral lift according to ... - PMC
PUL can be considered a safe and effective procedure for both preoperative urinary retention and nonurinary retention patients with prostate volumes <100 mL
8.
urolift.com
urolift.com/patients/about-us/press-releases/urolift-system-real-world-effectiveness-dataTeleflex Announces Real-World Data Demonstrating the ...
Findings Presented at European Association of Urology Show Consistent Positive Results for Minimally Invasive UroLift System Treatment.
NCT01294150 | The Safety and Effectiveness of UroLift: ...
The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement)
How Safe Is the UroLift Procedure For Enlarged Prostate?
Approved by major health authorities, UroLift has shown high success rates and fewer complications compared to more invasive options. While generally safe, ...
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