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

NCT ID: NCT05784558

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-03

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UroLift System

Therapy to be treatment with the UroLift System.

UroLift System

Intervention Type 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.

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.

Watchful Waiting or BPH Medications

Intervention Type OTHER

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.

Other Surgical Intervention

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Surgical Intervention

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NeoTract, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CP00022

Identifier Type: OTHER

Identifier Source: secondary_id

CP00022

Identifier Type: -

Identifier Source: org_study_id

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