Benign Prostatic HyperplasiaNCT03075449
Real World Data on Management of Male LUTS
An observational study of Benign Prostatic Hyperplasia, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
This study will describe the current medical care given to men who discuss their lower urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the baseline characteristics of these men, the treatment received, and the practice patterns of specifically a primary care physician managing… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2016to 21 Dec 2016
- 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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: men
Who may be able to join
- Males, aged ≥18 years old.
- Having had discussion of urinary symptoms with their PCP between 15 days and 12 months prior to the date of the phone interview.
- Able to read, speak and understand English.
- Willing to provide informed consent for study participation, authorize the release of their previous 12-month medical records from their PCP for review and de-identified data entry by Mapi into an electronic study database.
Who cannot join
- Reported during screening that they had had their first-ever discussion of urinary symptoms with PCP within the 14 days prior to the date of the phone interview.
- Participation in a clinical research study that evaluated urinary symptoms in the past 12 months.
- Self-reported history of colorectal, bladder or prostate cancer.
- Self-reported neurologic disorders that affect bladder function, e.g., neurogenic bladder disorders due to spinal cord injury/disease, multiple sclerosis, Parkinsons disease.
- Self-reported history of radiation therapy to the lower abdominal and/or pelvic region.
Trial locations and contacts
1 site in 1 country.
United States1 site
527.87.10001 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
About this study
Official title: Real World Data Exploring the Practices of Primary Care Providers in the Managment of Male Lower Urinary Tract Symptoms
This study will describe the current medical care given to men who discuss their lower urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the baseline characteristics of these men, the treatment received, and the practice patterns of specifically a primary care physician managing these patients.
- Conditions
- Benign Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records
The percentage of men who have been given at least one prescription medication for urinary symptoms.
This included any medications prescribed by PCP for urinary symptoms according to medical records within 12 months prior to telephone survey as described below:
- Medications already prescribed by PCP for urinary symptoms prior to the 1st visit/contact for urinary symptoms within 12 months prior to telephone survey.
- Medications newly prescribed by PCP upon visit(s)/contact(s) for urinary symptoms within 12 months prior to telephone survey (i.e., medications prescribed for urinary symptoms on or after the 1st visit/contact).
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.
Measured: 12 months
Secondary outcomes (7)
The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.
The percentage of men who received a medical diagnosis for their urinary symptoms, as recorded in their medical records.
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.
Measured: 12 months
The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms.
The percentage of men with a diagnostic testing procedure ordered or performed specifically for their urinary symptoms.
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.
Measured: 12 months
The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).
The percentage of men diagnosed with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) (enlarged prostate).
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.
Measured: 12 months
The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.
The percentage of men referred to a urologist for their urinary symptoms.
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.
Measured: 12 months
The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms.
The percentage of men given a prescription for an alpha-blocker for their urinary symptoms.
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.
Measured: 12 months
The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.
The percentage of men given repeat prescriptions for their urinary symptoms.
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.
Measured: 12 months
The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview.
The number of urinary-symptom related visits to their primary care provider (PCP) during the 12 month period prior to telephone survey interview.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start19 May 2016
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
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 Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075449
- Sponsor's protocol ID
- 527.87
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2017
- Last updated
- 26 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Data Exploring the Practices of Primary Care Providers in the Managment of Male Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT03075449
- Acronym / sponsor ID
- 527.87
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 19 May 2016 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 26 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will describe the current medical care given to men who discuss their lower urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the baseline characteristics of these men, the treatment received, and the practice patterns of specifically a primary care physician managing these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men
Key inclusion criteria (4 listed)
- Males, aged ≥18 years old.
- Having had discussion of urinary symptoms with their PCP between 15 days and 12 months prior to the date of the phone interview.
- Able to read, speak and understand English.
- Willing to provide informed consent for study participation, authorize the release of their previous 12-month medical records from their PCP for review and de-identified data entry by Mapi into an electronic study database.
Key exclusion criteria (5 listed)
- Reported during screening that they had had their first-ever discussion of urinary symptoms with PCP within the 14 days prior to the date of the phone interview.
- Participation in a clinical research study that evaluated urinary symptoms in the past 12 months.
- Self-reported history of colorectal, bladder or prostate cancer.
- Self-reported neurologic disorders that affect bladder function, e.g., neurogenic bladder disorders due to spinal cord injury/disease, multiple sclerosis, Parkinsons disease.
- Self-reported history of radiation therapy to the lower abdominal and/or pelvic region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records
Time frame: 12 months
The percentage of men who have been given at least one prescription medication for urinary symptoms. This included any medications prescribed by PCP for urinary symptoms according to medical records within 12 months prior to telephone survey as described below: 1. Medications already prescribed by PCP for urinary symptoms prior to the 1st visit/contact for urinary symptoms within 12 months prior to telephone survey. 2. Medications newly prescribed by PCP upon visit(s)/contact(s) for urinary symptoms within 12 months prior to telephone survey (i.e., medications prescribed for urinary symptoms on or after the 1st visit/contact). 95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution.
7 secondary outcomes
The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.
Time frame: 12 months
The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms.
Time frame: 12 months
The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).
Time frame: 12 months
The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.
Time frame: 12 months
The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms.
Time frame: 12 months
The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.
Time frame: 12 months
The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Boehringer Ingelheim at 1 site in United States.
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 4 inclusion and 5 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 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 26 Mar 2020). 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?
The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2020.