Prostatic HyperplasiaNCT01334723

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

An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Prostatic Hyperplasia
What is being tested?: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy and Non-adherent to 5ARI therapy
How many people: 35,032 participants
Where: No sites listed yet
Study dates: Apr 2010to Jun 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: Male patients aged 50 years or older with a diagnostic claim of BPH and prescription claim for a 5ARI for at least 60 days during the observation period. Patients will be required to be continuously eligible for 6 months prior to and at least 6 months after index date.

Who may be able to join

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.

Who cannot join

prostate cancer
any prostate-related surgical procedure prior to index date

About this study

Conditions: Prostatic Hyperplasia
Being tested: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy, Non-adherent to 5ARI therapy
Keywords: Benign prostatic hyperplasia, enlarged prostate, 5-alpha-reductase inhibitor, adherence, surgery, acute urinary retention
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adherent with 5-alpha-reductase inhibitor (5ARI) therapyDrug
Also called Proscar® is a registered trademark of Merck, Avodart® is a registered trademark of GlaxoSmithKline
Patient with BPH who are adherent to 5ARI therapy (Adherence will be calculated using a medication possession ratio (MPR); 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)
Non-adherent to 5ARI therapyDrug
Also called Proscar® is a registered trademark of Merck, Avodart® is a registered trademark of GlaxoSmithKline
Patients with BPH non-adherent to 5ARI therapy (Adherence will be calculated using a MPR; 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)

Study groups in NCT01334723
Study group	Role	What they receive
Acute Urinary Retention		This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome. Receives: Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy; Drug: Non-adherent to 5ARI therapy
Prostate Surgery		This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome. Receives: Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy; Drug: Non-adherent to 5ARI therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%
Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.
Measured: 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%
Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%.
Measured: 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%
Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%.
Measured: 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

Secondary outcomes (5)

Mean Length of 5-ARI Therapy
In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery.
Measured: 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
Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70%
In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=70% versus <70%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).
Measured: 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
Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75%
In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=75% versus <75%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).
Measured: 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
Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80%
In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=80% versus <80%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).
Measured: 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
BPH-Related Costs for Every 30 Days of 5-ARI Therapy
In this analysis, we evaluated mean BPH-related costs for every 30 days of 5-ARI therapy. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jun 2010

First posted13 Apr 2011 (estimated)
Study startApr 2010
Primary completionApr 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 35,032 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01334723
Sponsor's protocol ID: 114482
Status last verified: May 2017
First submitted: 7 Apr 2011
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT01334723
Acronym / sponsor ID: 114482
Conditions: Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia, enlarged prostate, 5-alpha-reductase inhibitor, adherence, surgery, acute urinary retention
Study type: Observational
Recruitment status: Completed
Enrolment: 35,032 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Apr 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 13 Apr 2011 (estimated)
Results: Posted 28 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Acute Urinary Retention	–	Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy, Drug: Non-adherent to 5ARI therapyThis subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
Prostate Surgery	–	Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy, Drug: Non-adherent to 5ARI therapyThis subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Male patients aged 50 years or older with a diagnostic claim of BPH and prescription claim for a 5ARI for at least 60 days during the observation period. Patients will be required to be continuously eligible for 6 months prior to and at least 6 months after index date.

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

prostate cancer
any prostate-related surgical procedure prior to index date

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adherent with 5-alpha-reductase inhibitor (5ARI) therapyAlso: Proscar® is a registered trademark of Merck, Avodart® is a registered trademark of GlaxoSmithKlinePatient with BPH who are adherent to 5ARI therapy (Adherence will be calculated using a medication possession ratio (MPR); 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)	Drug	Acute Urinary Retention, Prostate Surgery
Non-adherent to 5ARI therapyAlso: Proscar® is a registered trademark of Merck, Avodart® is a registered trademark of GlaxoSmithKlinePatients with BPH non-adherent to 5ARI therapy (Adherence will be calculated using a MPR; 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)	Drug	Acute Urinary Retention, Prostate Surgery

Primary outcome

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%
Time frame: The 5 and a half year period from January 1, 2000 to June 30, 2006
Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.
Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%
Time frame: 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
Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%.
Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%
Time frame: 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
Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%.

5 secondary outcomes

Mean Length of 5-ARI Therapy
Time frame: 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
Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70%
Time frame: 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
Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75%
Time frame: 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
Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80%
Time frame: 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
BPH-Related Costs for Every 30 Days of 5-ARI Therapy
Time frame: 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

Results and safety

Results posted to the registry on 28 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Urinary Retention Outcomes Cohort	17,293	17,293
Prostate Surgery Outcomes Cohort	17,739	17,739

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

Time frame: The 5 and a half year period from January 1, 2000 to June 30, 2006. Number. Unit: participants

Measure	Acute Urinary Retention Outcomes Cohort, MPR <=70% n = 7651	Acute Urinary Retention Outcomes Cohort, MPR >70% n = 9642	Prostate Surgery Outcomes Cohort, MPR <=70% n = 7386	Prostate Surgery Outocomes Cohort, MPR >70% n = 10353
Number of Participants with AUR and Surgery	2140	1587	481	331
Number of Participants without AUR and Surgery	5511	8055	6905	10022

Acute Urinary Retention Outcomes Cohort, MPR <=70% vs Acute Urinary Retention Outcomes Cohort, MPR >70%: Hazard Ratio (HR): 0.380 (95% CI 0.350 to 0.412)
Prostate Surgery Outcomes Cohort, MPR <=70% vs Prostate Surgery Outocomes Cohort, MPR >70%: Hazard Ratio (HR): 0.294 (95% CI 0.235 to 0.368)

Population analysed: Enrolled Population: participants in the IHCIS database with a diagnosis of benign prostate hyperplasia or enlarged prostate as indicated by ICD-9-CM code on claims (222.2x or 600.xx). Participants were included if they had at least 60 days of 5-ARI therapy during the enrollment period, 6 months of continuous enrollment, and no prior surgery.

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

Time frame: 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. Unit: participants

Measure	Acute Urinary Retention Outcomes Cohort, MPR <=75% n = 10413	Acute Urinary Retention Outcomes Cohort, MPR >75% n = 6880	Prostate Surgery Outcomes Cohort, MPR <=75% n = 11107	Prostate Surgery Outcomes Cohort, MPR >75% n = 6632
Number of Participants with AUR and surgery	2755	1277	627	185
Number of Participants without AUR and surgery	7658	5603	10480	6447

Acute Urinary Retention Outcomes Cohort, MPR <=75% vs Acute Urinary Retention Outcomes Cohort, MPR >75%: Hazard Ratio (HR): 0.613 (95% CI 0.562 to 0.668)
Prostate Surgery Outcomes Cohort, MPR <=75% vs Prostate Surgery Outcomes Cohort, MPR >75%: Hazard Ratio (HR): 0.542 (95% CI 0.427 to 0.689)

Population analysed: Enrolled Population

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

Measure	Acute Urinary Retention Outcomes Cohort, MPR <=80% n = 11787	Acute Urinary Retention Outcomes Cohort, MPR >80% n = 5506	Prostate Surgery Outcomes Cohort, MPR <=80% n = 11953	Prostate Surgery Outcomes Cohort, MPR >80% n = 5786
Number of Participants with AUR and surgery	2812	915	627	185
Number of Participants without AUR and surgery	8975	4591	11326	5601

Acute Urinary Retention Outcomes Cohort, MPR <=80% vs Acute Urinary Retention Outcomes Cohort, MPR >80%: Hazard Ratio (HR): 0.519 (95% CI 0.472 to 0.570)
Prostate Surgery Outcomes Cohort, MPR <=80% vs Prostate Surgery Outcomes Cohort, MPR >80%: Hazard Ratio (HR): 0.436 (95% CI 0.333 to 0.570)

Population analysed: Enrolled Population

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Urinary Retention Outcomes Cohort	0 of 0	0 of 0	Not reported
Prostate Surgery Outcomes Cohort	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostatic Hyperplasia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70% (time frame: The 5 and a half year period from January 1, 2000 to June 30, 2006). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.