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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 Intervention
Other: Watchful Waiting or BPH Medications
Device: 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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Other Surgical InterventionOther Surgical InterventionPhysician decides the best course of therapy to be a surgical intervention other than the UroLift System.
Watchful Waiting or BPH MedicationsWatchful Waiting or BPH MedicationsSubjects for whom the physician decides the best course of therapy to be either watchful waiting or new or continuing BPH medications.
UroLift SystemUroLift SystemTherapy to be treatment with the UroLift System.
Primary Outcome Measures
NameTimeMethod
To identify responders of IPSS change3 months post-treatment visit

Change of \>3 points in IPSS score from baseline to the 3 months post-treatment visit.

Secondary Outcome Measures
NameTimeMethod
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