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

NeoTract

Status and phase: Enrolling; Phase 4

Conditions: BPH

Treatments: Drug: Tamsulosin Hydrochloride; Device: UroLift System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04987892

CP00014

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Prostatic Lift

Active Comparator group

Description:

Treatment with the UroLift System

Treatment:

Device: UroLift System

Medication

Active Comparator group

Description:

Treatment with Tamsulosin HCl 0.4mg

Treatment:

Drug: Tamsulosin Hydrochloride