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NCT05784558 Clinical Trial

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

Benign Prostatic Hyperplasia Clinical Trial

— RELIEF  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05784558
Other study ID # CP00022
Secondary ID CP00022
Status Not yet recruiting
Phase
First received
Last updated
Start date April 3, 2023
Est. completion date December 31, 2030

Study information
Verified date February 2023
Source NeoTract, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 2500
Est. completion date December 31, 2030
Est. primary completion date December 31, 2029
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• UroLift 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.
Other:
• 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.
Device:
• Other Surgical Intervention
Physician decides the best course of therapy to be a surgical intervention other than the UroLift System.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NeoTract, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary To identify responders of IPSS change Change of >3 points in IPSS score from baseline to the 3 months post-treatment visit. 3 months post-treatment visit
See also
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Completed NCT00224133 - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months Phase 3
Unknown status NCT00381108 - Study of the Effects of Pomegranate Tablets on Enlarged Prostates Phase 1
Completed NCT00701779 - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Phase 4
Terminated NCT02962674 - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT04853914 - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. N/A