Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH (IMPACT)

Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia

This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).

Study Overview

• Status: Recruiting
• Conditions: BPH
• Intervention / Treatment: Device: UroLift System; Drug: Tamsulosin Hydrochloride

Detailed Description

This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).Men 45 or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). BPH symptoms may range from mild (8) to severe (35) on the IPSS scale. All enrolled men must meet selection criteria and be candidates for therapy with both UroLift System and 0.4 mg tamsulosin HCl.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rogers Mitchell; Phone Number: 805-403-7107; Email: rogers.mitchell@neotract.com

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • Recruiting
      • Neotract
      • Contact: Rogers Mitchell; Phone Number: 925-329-6493; Email: USPLEClinicalPayments@teleflex.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male 45 years of age or older
2. Diagnosis of BPH
3. Experiencing symptoms of BPH as indicated by an IPSS ≥8 and ≤30
4. Willing to wash out of current BPH medication(s), as applicable
5. An appropriate candidate for both BPH therapies evaluated in this study.
6. Ability to understand and consent to participate in this study
7. Willing and able to participate in follow-up evaluations

Exclusion Criteria:

1. Use of alpha blocker for BPH unless washed-out for 30 days
2. Use of daily phosphodiesterase type 5 inhibitor (PDE5i) for BPH unless washed-out for 30 days
3. 5-alpha-reductase inhibitors for BPH used within 6 months of therapy initiation
4. Current urinary tract infection or prostatitis
5. Current gross hematuria
6. Urinary incontinence presumed due to incompetent sphincter
7. Catheter-dependent urinary retention within 1 month prior to enrollment
8. Prostate volume greater than 100 cc as measured by TRUS
9. Prostate specific antigen level of greater than 10 ng/ml within one year of enrollment unless prostate cancer has been ruled out
10. History of neurogenic or atonic bladder
11. History prostate cancer treatment
12. Known to be hypersensitive to tamsulosin HCl or any component of tamsulosin HCl capsules
13. Known allergy to nickel, titanium, or stainless steel
14. Prior minimally invasive or surgical intervention for BPH
15. Urethral conditions that may prevent insertion of delivery system into bladder.
16. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
17. History of medical, surgical or other conditions that, in the opinion of the investigator, would interfere with the treatment or evaluation of the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prostatic Lift; Treatment with the UroLift System	Device: UroLift System; Prostatic lift
Active Comparator: Medication; Treatment with Tamsulosin HCl 0.4mg	Drug: Tamsulosin Hydrochloride; Tamsulosin HCl 0.4mg; Other Names: Flomax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paired comparison of International Prostate Symptom Score (IPSS) percent change	The primary study analysis compares the change in BPH symptoms in the PUL Arm to the change in BPH symptoms in the MED Arm measured 3 months after BPH therapy initiation. This will be measure by International Prostate Symptom Score (IPSS) percent change. IPSS ranges from 0-35, healthier patients have lower scores than patients more effected by BPH symptoms.	3 Months after Therapy Initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life (QoL)	The secondary analysis assesses the change in quality of life (QoL) due to urinary symptoms between the PUL and MED Arms measured 3 months after initiation of BPH therapy. This will be measured by change in QoL, ranging from 0-6. Healthier patients have lower scores than patients more effected by BPH symptoms.	3 months after BPH Therapy Initiation

Collaborators and Investigators

• Sponsor: NeoTract, Inc.
• Investigators: Principal Investigator: Claus Roehrborn, M.D., University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: CP00014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes