Comparing medication and a procedure for treating BPH

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

This study is testing whether a procedure called the Prostatic Urethral Lift works better than a common medication for helping men with BPH symptoms feel better.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 45 Years and up
• Sex: Male
• Sponsor: NeoTract, Inc. (industry)
• Locations: 1 site (Pleasanton, California)
• Trial ID: NCT04987892 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized controlled trial enrolling approximately 250 males aged 45 and older diagnosed with symptomatic benign prostatic hyperplasia (BPH). Participants will be randomly assigned to receive either the Prostatic Urethral Lift procedure using the UroLift System or 0.4mg tamsulosin HCl. The study aims to assess and compare the effectiveness of these two therapies in alleviating BPH symptoms. All subjects will undergo follow-up evaluations to monitor their progress and response to treatment.

Who should consider this trial

Good fit: Ideal candidates are males aged 45 and older with a diagnosis of symptomatic BPH and an IPSS score between 8 and 30.

Not a fit: Patients with severe urinary complications or those currently using certain BPH medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment options for men suffering from BPH, potentially improving their quality of life.

How similar studies have performed: Other studies have shown success with similar approaches in treating BPH, indicating that this methodology is not entirely novel.

Eligibility 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

Where this trial is running

Pleasanton, California

• Neotract — Pleasanton, California, United States (RECRUITING)

Study contacts

• Principal investigator: Claus Roehrborn, M.D. — University of Texas Southwestern Medical Center
• Study coordinator: Rogers Mitchell

Conditions: BPH