RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up

NCT05784558 | Withdrawn FDA Device

• 1 other identifier: CP00022
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• To identify responders of IPSS change

  Change of \>3 points in IPSS score from baseline to the 3 months post-treatment visit.

  3 months post-treatment visit

Study Arms (3)

UroLift System

Therapy to be treatment with the UroLift System.

Device: UroLift System

Watchful Waiting or BPH Medications

Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications.

Other: Watchful Waiting or BPH Medications

Other Surgical Intervention

Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.

Device: Other Surgical Intervention

Interventions

Other Surgical Intervention DEVICE

Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.

Other Surgical Intervention

UroLift System DEVICE

The UroLift System is a procedure that utilizes tiny implants to lift and hold the enlarged prostate tissue out of the way so it no longer blocks the urethra.

UroLift System

Watchful Waiting or BPH Medications OTHER

Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications.

Watchful Waiting or BPH Medications

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH)

You may qualify if:

• Diagnosis of symptomatic BPH

You may not qualify if:

• Prior surgical intervention for treatment of BPH
• Unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments

Sponsors & Collaborators

• NeoTract, Inc.: lead

Study Sites (1)

Neotract Inc

Pleasanton, California, 94566, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 27, 2023
• Study Start: January 26, 2025
• Primary Completion: January 26, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)