Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- NeoTract, Inc.
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Paired comparison of International Prostate Symptom Score (IPSS) percent change
Study Overview
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).
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •5-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.
- •Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
- •History of medical, surgical or other conditions that, in the opinion of the investigator, would interfere with the treatment or evaluation of the subject
Arms & Interventions
Prostatic Lift
Treatment with the UroLift System
Intervention: UroLift System (Device)
Medication
Treatment with Tamsulosin HCl 0.4mg
Intervention: Tamsulosin Hydrochloride (Drug)
Outcomes
Primary Outcomes
Paired comparison of International Prostate Symptom Score (IPSS) percent change
Time Frame: 3 Months after Therapy Initiation
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.
Secondary Outcomes
- Change in Quality of Life (QoL)(3 months after BPH Therapy Initiation)