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
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten
- 527.87.10001 Boehringer Ingelheim Investigational Site
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Retrospektive
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records
Zeitfenster: 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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 12 months
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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.
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 527.87
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