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

NCT04987892 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: CP00014
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

BPH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Quality of Life (QoL)

  3 months after BPH Therapy Initiation

Study Arms (2)

Prostatic Lift

ACTIVE COMPARATOR

Treatment with the UroLift System

Device: UroLift System

Medication

ACTIVE COMPARATOR

Treatment with Tamsulosin HCl 0.4mg

Drug: Tamsulosin Hydrochloride

Interventions

UroLift System DEVICE

Prostatic lift

Prostatic Lift

Tamsulosin Hydrochloride DRUG

Tamsulosin HCl 0.4mg

Also known as: Flomax

Medication

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Patients must be male. The study is evaluation the population of men diagnosed with benign prostatic hyperplasia.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use of alpha blocker for BPH unless washed-out for 30 days
• Use of daily phosphodiesterase type 5 inhibitor (PDE5i) for BPH unless washed-out for 30 days
• alpha-reductase inhibitors for BPH used within 6 months of therapy initiation
• Current urinary tract infection or prostatitis
• Current gross hematuria
• Urinary incontinence presumed due to incompetent sphincter
• Catheter-dependent urinary retention within 1 month prior to enrollment
• Prostate volume greater than 100 cc as measured by TRUS
• Prostate specific antigen level of greater than 10 ng/ml within one year of enrollment unless prostate cancer has been ruled out
• History of neurogenic or atonic bladder
• History prostate cancer treatment
• Known to be hypersensitive to tamsulosin HCl or any component of tamsulosin HCl capsules
• Known allergy to nickel, titanium, or stainless steel
• Prior minimally invasive or surgical intervention for BPH
• Urethral conditions that may prevent insertion of delivery system into bladder.

Sponsors & Collaborators

• NeoTract, Inc.: lead

Study Sites (1)

Neotract

Pleasanton, California, 94588, United States

RECRUITING

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Claus Roehrborn, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rogers Mitchell

CONTACT

805-403-7107; rogers.mitchell@neotract.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 3, 2021
• Study Start: December 6, 2021
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

US (1)