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

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ClinicalTrials.gov Identifier: NCT04987892
Recruitment Status : Recruiting
First Posted : August 3, 2021
Last Update Posted : April 25, 2023
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
BPH Device: UroLift System Drug: Tamsulosin Hydrochloride Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia
Actual Study Start Date : December 6, 2021
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Flomax


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Quality of Life (QoL) [ Time Frame: 3 months after BPH Therapy Initiation ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients must be male. The study is evaluation the population of men diagnosed with benign prostatic hyperplasia.
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04987892


Contacts
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Contact: Rogers Mitchell 805-403-7107 rogers.mitchell@neotract.com

Locations
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United States, California
Neotract Recruiting
Pleasanton, California, United States, 94588
Contact: Rogers Mitchell    925-329-6493    USPLEClinicalPayments@teleflex.com   
Sponsors and Collaborators
NeoTract, Inc.
Investigators
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Principal Investigator: Claus Roehrborn, M.D. University of Texas Southwestern Medical Center
More Information
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Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT04987892    
Other Study ID Numbers: CP00014
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023

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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
Additional relevant MeSH terms:
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Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents