Real World Data on Management of Male LUTS
Real World Data Exploring the Practices of Primary Care Providers in the Managment of Male Lower Urinary Tract Symptoms
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Kentucky
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Lexington, Kentucky, Estados Unidos
- 527.87.10001 Boehringer Ingelheim Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records
Periodo de tiempo: 12 months
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.
Periodo de tiempo: 12 months
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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
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The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms.
Periodo de tiempo: 12 months
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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
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The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).
Periodo de tiempo: 12 months
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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
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The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.
Periodo de tiempo: 12 months
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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
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The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms.
Periodo de tiempo: 12 months
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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
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The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.
Periodo de tiempo: 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. |
12 months
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The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview.
Periodo de tiempo: 12 months
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The number of urinary-symptom related visits to their primary care provider (PCP) during the 12 month period prior to telephone survey interview.
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12 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 527.87
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