Last updated: 02/24/2020 10:10:10

A retrospective database analysis of clinical outcomes in BPH patients treated with 5-alpha reductase inhibitors in the Netherlands.

GSK study ID
116831
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A retrospective database analysis of clinical outcomes in BPH patients treated with 5‑alpha reductase inhibitors in the Netherlands.
Trial description: The primary objective of this retrospective database study is:
• To examine rates of prostate surgery and urinary retention after treatment initiation of dutasteride compared to finasteride in men aged ≥50 years diagnosed with BPH
Secondary objectives of this retrospective database study are:
• To examine BPH drug treatment patterns of men aged ≥50 years diagnosed with BPH
• To examine health care utilization of men aged ≥50 years diagnosed with BPH after treatment initiation of finasteride or dutasteride
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Urinary retention

Timeframe: from index date to December 31, 2011

BPH related surgery

Timeframe: from index date to December 31, 2011

Secondary outcomes:

Health care utilization

Timeframe: from index date to December 31, 2011

5-ARI persistence rate

Timeframe: from index date to December 31, 2011

Interventions:
Not applicable
Enrollment:
17603
Primary completion date:
2014-03-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Josephina G. Kuiper, Irene D. Bezemer, Maurice T. Driessen, Averyan Vasylyev, Claus G. Roehrborn, Fernie JA. Penning-van Beest, Ron MC. Herings. Rates of prostate surgery and acute urinary retention for benign prostatic hyperplasia in men treated with dutasteride or finasteride . BMC Urol. 2016;16(53):
Medical condition
Benign Prostatic Hyperplasia, Urologic Diseases
Product
alfuzosin, dutasteride, dutasteride/tamsulosin, finasteride, silodosin, tamsulosin, terazosin
Collaborators
Not applicable
Study date(s)
July 2012 to November 2014
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Male
Age
50+ years
Accepts healthy volunteers
none
  • Additional inclusion criteria were:
  • at least 12 months history in the PHARMO Database Network before cohort entry
Inclusion and exclusion criteria
Inclusion criteria:

    Additional inclusion criteria were:

    • at least 12 months history in the PHARMO Database Network before cohort entry
    • at least 12 months follow-up in the PHARMO Database Network after cohort entry As the indication of 5-ARI use is not recorded in the dispensing records, the following exclusion criteria were applied to increase specificity for BPH in the patient selection:
    • Dose of first finasteride dispensing 1mg (indicated for androgenic alopecia)
    • Women
    • <50 years at cohort entry Additional exclusion criteria were:
    • Prostate surgery before cohort entry
    • Hospital admission for urinary retention before cohort entry
    • Hospital admission for prostate cancer before cohort

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2014-03-11
Actual study completion date
2014-03-11

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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