RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up
Overview
- Phase
- Not Applicable
- Intervention
- UroLift System
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- NeoTract, Inc.
- Enrollment
- 2500
- Locations
- 1
- Primary Endpoint
- To identify responders of IPSS change
- Status
- Withdrawn
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
UroLift System
Therapy to be treatment with the UroLift System.
Intervention: UroLift System
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: Watchful Waiting or BPH Medications
Other Surgical Intervention
Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.
Intervention: Other Surgical Intervention
Outcomes
Primary Outcomes
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.