Clinical trial NCT04987892: Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH
Official title: Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: BPH
Lead sponsor: NeoTract, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 250
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Paired comparison of International Prostate Symptom Score (IPSS) percent change
timeFrame: 3 Months after Therapy Initiation
Secondary outcomes:
measure: Change in Quality of Life (QoL)
timeFrame: 3 months after BPH Therapy Initiation
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Neotract
state: California
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Claus Roehrborn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: