Real World Data on Management of Male LUTS

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Real World Data Exploring the Practices of Primary Care Providers in the Managment of Male Lower Urinary Tract Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075449
• Other study ID #: 527.87
• Status: Completed
• Start date: May 19, 2016
• Est. completion date: December 21, 2016

Study information

• Verified date: March 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
United States	527.87.10001 Boehringer Ingelheim Investigational Site	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months

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