Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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:
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
men
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 527.87.10001 Boehringer Ingelheim Investigational Site | Lexington | Kentucky | United States |
A cross-sectional participant survey study combined with 12 months of retrospective data collection from participant's PCP medical records.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The enrolled set contains all men who have met all study eligibility criteria and have returned the signed ICF. This includes meeting eligibility criteria according to medical records.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months |
|
Not provided
No safety data was planned to be collected for this study thus adverse events are not reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | 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 |
|
|
| 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. | FAS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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. | FAS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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. | FAS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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. | FAS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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. | FAS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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. | FAS | Posted | Number | 95% Confidence Interval | Percentage of participants | 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. | FAS | Posted | Mean | Standard Deviation | urinary symptom-related visits | 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D052801 |
| Male Urogenital Diseases |