Real World Data on Management of Male LUTS

Completed

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT03075449
• Lead Sponsor: Boehringer Ingelheim

Brief 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 these patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-19
• Primary Completion: 2016-12-21
• Study Completion: 2016-12-21
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-09
• Status Verified: 2020-03
• Results First Submitted: 2020-03-12
• Results First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Results First Posted: 2020-03-26
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 201

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records	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.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.	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.
The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms.	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.
The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.	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.
The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).	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.
The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.	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.
The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms.	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.
The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview.	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.

Trial Locations

Locations (1)

527.87.10001 Boehringer Ingelheim Investigational Site; 🇺🇸 Lexington, Kentucky, United States