Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

NCT01332487 | Completed Results

• 1 other identifier: 114461
• Study Type: observational
• Target: 4,068
• Locations: 0 countries
• Sites: N/A

Brief Summary

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).

Conditions

Prostatic Hyperplasia

Keywords

5-alpha-reductase inhibitor; prostate surgery; alpha-blocker; enlarged prostate; acute urinary retention; Benign prostatic hyperplasia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Progression of Disease

  The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.

  Up to 5 months

Secondary Outcomes (1)

• Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery

  6 months

Study Arms (2)

Early initiation of 5ARI therapy

Patients starting 5ARI therapy within 30 days of initiating AB therapy

Drug: 5ARI + AB

Delayed initiation of 5ARI therapy

Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy

Drug: 5ARI + AB

Interventions

5ARI + AB DRUG

5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Delayed initiation of 5ARI therapy; Early initiation of 5ARI therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male patients aged 50 years or older with a diagnostic claim for BPH; prescription claim for an AB and a 5ARI in the observation period

You may qualify if:

• Male
• aged 50 years or older
• diagnostic claim for BPH
• prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
• continuously eligible for 6 months prior to and 12 months after index prescription date

You may not qualify if:

• prostate or bladder cancer during the study period
• any prostate-related surgical procedure within 5 months of the index prescription date
• prescription claim for finasteride 1 mg for male pattern baldness during the study period
• ARI therapy prior to initiation of AB therapy

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: August 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 19, 2017
• Results First Posted: February 29, 2012

Record last verified: 2017-05