Benign Prostatic Hyperplasia
Conditions
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
A cross-sectional participant survey study combined with 12 months of retrospective data collection from participant's PCP medical records.
Participants by arm
| Arm | Count |
|---|---|
| Participant Data Reported by Telephone Survey + Medical Record Participant-reported data during the telephone survey and the medical record from the Primary Care Provider (PCP) from which medical data were abstracted by the medical data abstractor in the Management of Male Lower Urinary Tract Symptoms | 170 |
| Total | 170 |
Baseline characteristics
| Characteristic | Participant Data Reported by Telephone Survey + Medical Record |
|---|---|
| Age, Continuous | 62.1 Years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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: 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.
Time frame: 12 months
Population: Full Analysis Set (FAS): The FAS consists of all enrolled men whose PCP has provided their medical record with at least one urinary symptom recorded between 15 days and 12 months prior to telephone survey interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Data Reported by Telephone Survey + Medical Record | The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records | 35.7 Percentage of participants |
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participant Data Reported by Telephone Survey + Medical Record | The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview. | 1.8 urinary symptom-related visits | Standard Deviation 1.24 |
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Data Reported by Telephone Survey + Medical Record | The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate). | 42.9 Percentage of participants |
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Data Reported by Telephone Survey + Medical Record | The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms. | 26.2 Percentage of participants |
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Data Reported by Telephone Survey + Medical Record | The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms. | 33.3 Percentage of participants |
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Data Reported by Telephone Survey + Medical Record | The Percentage of Men Referred to a Urologist for Their Urinary Symptoms. | 48.8 Percentage of participants |
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Data Reported by Telephone Survey + Medical Record | The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records. | 79.8 Percentage of participants |
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.
Time frame: 12 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participant Data Reported by Telephone Survey + Medical Record | The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms. | 61.9 Percentage of participants |