Real World Data on Management of Male LUTS

March 12, 2020 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States
        • 527.87.10001 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

men

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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.
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 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.
12 months
The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).
Time Frame: 12 months

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.
12 months
The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.
Time Frame: 12 months

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.
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 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.
12 months
The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.
Time Frame: 12 months

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.
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
The number of urinary-symptom related visits to their primary care provider (PCP) during the 12 month period prior to telephone survey interview.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2016

Primary Completion (Actual)

December 21, 2016

Study Completion (Actual)

December 21, 2016

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 527.87

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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