Real World Data on Management of Male LUTS

Boehringer Ingelheim201 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

201

Conditions

Benign Prostatic Hyperplasia

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

527.87.10001 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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: 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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Data from ClinicalTrials.gov

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