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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
Must not have
Current urinary tract infection or prostatitis
History prostate cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after therapy initiation
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 45 or older.
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I have been diagnosed with an enlarged prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have a urinary tract infection or prostatitis.
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I have been treated for prostate cancer in the past.
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I have had surgery or a minimal procedure for an enlarged prostate.
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I have a history of bladder control issues due to nerve problems.
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I have needed a catheter for urination in the last month.
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I have a condition that could make it hard to insert medical tools into my bladder.
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I am currently experiencing visible blood in my urine.
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My prostate is larger than 100 cc according to an ultrasound.
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I have urinary incontinence due to a weak bladder sphincter.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after bph therapy initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after bph therapy initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Paired comparison of International Prostate Symptom Score (IPSS) percent change
Secondary study objectives
Change in Quality of Life (QoL)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

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

Tamsulosin Hydrochloride (Alpha Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04987892 — Phase 4
Benign Prostatic Hyperplasia Research Study Groups: Prostatic Lift, Medication
Benign Prostatic Hyperplasia Clinical Trial 2023: Tamsulosin Hydrochloride Highlights & Side Effects. Trial Name: NCT04987892 — Phase 4
Tamsulosin Hydrochloride (Alpha Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987892 — Phase 4
~31 spots leftby May 2025
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