Trial Outcomes & Findings for Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia (NCT NCT01332487)

Last Updated: 2017-06-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

4068 participants

Primary outcome timeframe

Up to 5 months

Results posted on

2017-06-19

Participant Flow

Participants were neither recruited nor enrolled in this retrospective observational study. Data from medical records or insurance claims databases were anonymized.

Participant milestones

Participant milestones
Measure	Early Treatment Participants who started 5-alpha-reductase inhibitor (5ARI) therapy within 30 days of initiating alpha-blocker (AB) treatment	Delayed Treatment Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
Overall Study STARTED	5554	3063
Overall Study COMPLETED	5554	3063
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Treatment n=5554 Participants Participants who started 5ARI therapy within 30 days of initiating AB treatment	Delayed Treatment n=3063 Participants Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment	Total n=8617 Participants Total of all reporting groups
Age, Continuous	68.7 Years STANDARD_DEVIATION 10.2 • n=5 Participants	67.8 Years STANDARD_DEVIATION 10.1 • n=7 Participants	68.4 Years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	5554 Participants n=5 Participants	3063 Participants n=7 Participants	8617 Participants n=5 Participants
Mean Charlson Comorbidity Index Scores	1.03 scores on a scale STANDARD_DEVIATION 1.63 • n=5 Participants	0.86 scores on a scale STANDARD_DEVIATION 1.41 • n=7 Participants	0.97 scores on a scale STANDARD_DEVIATION 1.56 • n=5 Participants
Mean Benign Prostatic Hyperplasia (BPH) Disease Stage Scores	0.90 scores on a scale STANDARD_DEVIATION 1.11 • n=5 Participants	0.79 scores on a scale STANDARD_DEVIATION 0.98 • n=7 Participants	0.86 scores on a scale STANDARD_DEVIATION 1.07 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 months

Population: Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP)

Outcome measures

Outcome measures
Measure	Early Treatment n=5554 Participants Participants who started 5ARI therapy within 30 days of initiating AB treatment	Delayed Treatment n=3063 Participants Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
Number of Participants Who Experienced Progression of Disease Acute Urinary Retention	589 participants	393 participants
Number of Participants Who Experienced Progression of Disease Surgery	280 participants	212 participants
Number of Participants Who Experienced Progression of Disease Emergency Surgery	86 participants	52 participants

SECONDARY outcome

Timeframe: 6 months

Population: Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP). Only those participants who were treated with surgery within 182 days of the first prescription of 5ARI were analyzed.

Outcome measures

Outcome measures
Measure	Early Treatment n=106 Participants Participants who started 5ARI therapy within 30 days of initiating AB treatment	Delayed Treatment n=68 Participants Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery On the same day	37 participants	27 participants
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery Within 1 week	54 participants	35 participants
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery Within 1 month	85 participants	51 participants
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery Within 2 months	102 participants	60 participants
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery Within 3 months	105 participants	64 participants
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery Within 4 months	105 participants	66 participants
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery Within 5 months	105 participants	68 participants
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery Within 6 months (182 days)	106 participants	68 participants

Adverse Events

Early Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER