RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2021-12-06

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04987892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Study Contact

Rogers Mitchell

CONTACT

805-403-7107

rogers.mitchell@neotract.com

Principal Investigator

Claus Roehrborn, M.D.

PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Study Locations (Sites)

Neotract

Pleasanton, California, 94588

United States

Collaborators and Investigators

Sponsor: NeoTract, Inc.

Claus Roehrborn, M.D., PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-06

Study Completion Date2025-10

Study Record Updates