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

BPH Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987892
• Other study ID #: CP00014
• Status: Recruiting
• Phase: Phase 4
• Start date: December 6, 2021
• Est. completion date: October 2025

Study information

• Verified date: April 2023
• Source: NeoTract, Inc.
• Contact: Rogers Mitchell
• Phone: 805-403-7107
• Email: rogers.mitchell[@]neotract.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BPH

Intervention

Device:
• UroLift System
Prostatic lift

Drug:
• Tamsulosin Hydrochloride
Tamsulosin HCl 0.4mg

Locations

Country	Name	City	State
United States	Neotract	Pleasanton	California

Sponsors (1)

Lead Sponsor	Collaborator
NeoTract, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired comparison of International Prostate Symptom Score (IPSS) percent change	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.	3 Months after Therapy Initiation
Secondary	Change in Quality of Life (QoL)	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.	3 months after BPH Therapy Initiation