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

NeoTract

Status: Not yet enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Other Surgical Intervention; Device: UroLift System; Other: Watchful Waiting or BPH Medications

Study type: Observational

Funder types: Industry

Identifiers

NCT05784558

CP00022 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No 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

Trial design

2,500 participants in 3 patient groups

UroLift System

Description:

Therapy to be treatment with the UroLift System.

Treatment:

Device: UroLift System

Watchful Waiting or BPH Medications

Description:

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

Treatment:

Other: Watchful Waiting or BPH Medications

Other Surgical Intervention

Description:

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

Treatment:

Device: Other Surgical Intervention