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Alpha Blocker
Surgery vs. Medication for Benign Prostatic Hyperplasia (IMPACT Trial)
Phase 4
Recruiting
Led By Claus Roehrborn, M.D.
Research Sponsored by NeoTract, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male 45 years of age or older
Diagnosis of BPH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after bph therapy initiation
Awards & highlights
IMPACT Trial Summary
This trial will compare two treatments for BPH. One is a surgery called a Prostatic Urethral Lift, and the other is a medication called tamsulosin.
Who is the study for?
This trial is for males aged 45 or older with symptoms of benign prostatic hyperplasia (BPH), indicated by an IPSS score between 8 and 30. Participants must be willing to stop current BPH medications if needed, have no history of certain prostate treatments, and not suffer from conditions like urinary tract infections or severe allergies to specific metals.Check my eligibility
What is being tested?
The study compares two BPH therapies: the UroLift System procedure versus tamsulosin hydrochloride medication. It's a randomized controlled trial where participants are assigned randomly to either treatment group in equal numbers across multiple US sites.See study design
What are the potential side effects?
Possible side effects of the UroLift System may include discomfort during urination, blood in urine, pelvic pain, and infection risk. Tamsulosin can cause dizziness, issues with ejaculation, headache, fatigue, runny nose and allergic reactions.
IMPACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 45 or older.
Select...
I have been diagnosed with an enlarged prostate.
IMPACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after therapy initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after therapy initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Paired comparison of International Prostate Symptom Score (IPSS) percent change
Secondary outcome measures
Change in Quality of Life (QoL)
IMPACT Trial Design
2Treatment groups
Active Control
Group I: Prostatic LiftActive Control1 Intervention
Treatment with the UroLift System
Group II: MedicationActive Control1 Intervention
Treatment with Tamsulosin HCl 0.4mg
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Who is running the clinical trial?
NeoTract, Inc.Lead Sponsor
10 Previous Clinical Trials
3,150 Total Patients Enrolled
Claus Roehrborn, M.D.Principal InvestigatorUniversity of Texas Southwestern Medical Center
1 Previous Clinical Trials
184 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a suitable candidate for the BPH treatments being studied.I am a man aged 45 or older.I am willing and able to attend follow-up appointments.I currently have a urinary tract infection or prostatitis.My PSA level is over 10 ng/ml, but prostate cancer has been ruled out.I understand and agree to participate in this study.I have been treated for prostate cancer in the past.I have stopped taking PDE5 inhibitors for BPH for 30 days.I have had surgery or a minimal procedure for an enlarged prostate.I have a history of bladder control issues due to nerve problems.I have not used alpha blockers for BPH in the last 30 days.I have moderate symptoms from an enlarged prostate.I am willing to stop my current prostate medication if needed.I have used medication for prostate enlargement in the last 6 months.I have needed a catheter for urination in the last month.I have a condition that could make it hard to insert medical tools into my bladder.I am currently experiencing visible blood in my urine.My prostate is larger than 100 cc according to an ultrasound.I have urinary incontinence due to a weak bladder sphincter.I have been diagnosed with an enlarged prostate.
Research Study Groups:
This trial has the following groups:- Group 1: Prostatic Lift
- Group 2: Medication
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this pharmaceutical been sanctioned by the FDA?
"Our experts assigned Medication a score of 3 on the safety scale, since it has already been authorised and approved in Phase 4 trials."
Answered by AI
What ailments are commonly addressed with pharmaceuticals?
"Medication can be used to mitigate the symptoms of bladder outlet obstruction, ureteral calculus, and benign prostatic hyperplasia (BPH)."
Answered by AI
How many participants are qualified to partake in this clinical experiment?
"Affirmative. According to data found on clinicaltrials.gov, this trial is still in search of participants; the study was first published onDecember 6th 2021 and has been revised as recently as March 1st 2022. Currently, it needs 250 candidates from one location."
Answered by AI
Is this research currently recruiting participants?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is actively recruiting participants from one site with a total of 250 applicants needed for completion. The study was initially posted on December 6th 2021 and last updated on March 1st 2022."
Answered by AI
What previous research has been done related to this medication?
"Presently, there are 13 research projects concerning Medication with three of them in the final phase. Most trials are conducted in Baden, Aargau but various other locations also offer studies for this medication."
Answered by AI
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