Clinical trial NCT03075449: Real World Data on Management of Male LUTS
Official title: Real World Data Exploring the Practices of Primary Care Providers in the Managment of Male Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-03-09
Enrollment: 201
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: men

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records
timeFrame: 12 months
Secondary outcomes:
measure: The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.
timeFrame: 12 months
measure: The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms.
timeFrame: 12 months
measure: The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).
timeFrame: 12 months
measure: The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.
timeFrame: 12 months
measure: The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms.
timeFrame: 12 months
measure: The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.
timeFrame: 12 months
measure: The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview.
timeFrame: 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: 527.87.10001 Boehringer Ingelheim Investigational Site
state: Kentucky
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: