Benign Prostatic Hyperplasia
Conditions
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.
Interventions
DEVICEUroLift System
The UroLift System is a procedure that utilizes tiny implants to lift and hold the enlarged prostate tissue out of the way so it no longer blocks the urethra.
OTHERWatchful 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.
DEVICEOther Surgical Intervention
Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.
Sponsors
NeoTract, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed