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

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.

Study Overview

• Status: Withdrawn
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: UroLift System; Other: Watchful Waiting or BPH Medications; Device: Other Surgical Intervention

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94566
      • Neotract Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Men diagnosed with symptomatic Benign Prostatic Hyperplasia (BPH)

Description

Inclusion Criteria:

• Diagnosis of symptomatic BPH

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UroLift System; Therapy to be treatment with the UroLift System.	Device: UroLift System; 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.
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; Subjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing 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; Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NeoTract, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 26, 2025
• Primary Completion (Estimated): January 26, 2026
• Study Completion (Estimated): September 24, 2026

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: CP00022 (Other Identifier: NeoTract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No