Skip to main content
OpenTrials
Completed

NCT Number: NCT03075449

Real World Data on Management of Male LUTS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

527.87.10001 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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:

    • 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2017
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.