RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up
Not yet recruiting
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Device: Other Surgical InterventionOther: Watchful Waiting or BPH MedicationsDevice: UroLift System
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 2500
Inclusion Criteria
- Diagnosis of symptomatic BPH
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Other Surgical Intervention Other Surgical Intervention Physician decides the best course of therapy to be a surgical intervention other than the UroLift System. Watchful Waiting or BPH Medications 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. UroLift System UroLift System Therapy to be treatment with the UroLift System.
- 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.
- Secondary Outcome Measures
Name Time Method