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

Sponsor

NeoTract, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05784558

Collaborator

(none)

2,500

Enrollment

92.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Device: UroLift System Other: Watchful Waiting or BPH Medications Device: Other Surgical Intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 3, 2023

Anticipated Primary Completion Date :

Dec 31, 2029

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

To identify responders of IPSS change [3 months post-treatment visit]
Change of >3 points in IPSS score from baseline to the 3 months post-treatment visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

NeoTract, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NeoTract, Inc.

ClinicalTrials.gov Identifier:

NCT05784558

Other Study ID Numbers:

CP00022
CP00022

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Prostatic Hyperplasia

Hyperplasia

Study Results

No Results Posted as of Mar 27, 2023