CompletedNot Applicable

Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

35,032 participantsStarted 2010-04

Plain-language summary

This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).

Who can participate

Age range50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male * aged 50 years or older * a diagnostic claim of BPH * prescription claim for a 5ARI for at least 60 days during the observation period. * continuously eligible for 6 months prior to and at least 6 months after index date. Exclusion Criteria: * prostate cancer * any prostate-related surgical procedure prior to index date

What they're measuring

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%

Timeframe: The 5 and a half year period from January 1, 2000 to June 30, 2006

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Trial details

NCT IDNCT01334723

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-04

Results submitted2011-04-14

View on ClinicalTrials.gov More Prostatic Hyperplasia trials

Plain-language summary

Who can participate

Age range50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%

Timeframe: The 5 and a half year period from January 1, 2000 to June 30, 2006

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006