N/A
Completed N=170
Real World Data on Management of Male LUTS
Source: ClinicalTrials.gov NCT03075449 ↗Enrolled (actual)
170
Serious AEs
—
Results posted
Mar 2020
Primary outcomePrimary: The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records — 35.7 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records |
35.7 | — |
| SECONDARY The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records. |
79.8 | — |
| SECONDARY The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms. |
61.9 | — |
| SECONDARY The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate). |
42.9 | — |
| SECONDARY The Percentage of Men Referred to a Urologist for Their Urinary Symptoms. |
48.8 | — |
| SECONDARY The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms. |
26.2 | — |
| SECONDARY The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms. |
33.3 | — |
| SECONDARY The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview. |
1.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03075449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.