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

Not yet recruiting

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT05784558
• Lead Sponsor: NeoTract, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Study Start: 2023-04-03
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 2500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.