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

March 13, 2023 updated by: NeoTract, Inc.
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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoTract, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 3, 2023

Primary Completion (Anticipated)

December 31, 2029

Study Completion (Anticipated)

December 31, 2030

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 27, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP00022 (Other Identifier: NeoTract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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