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Real World Data on Management of Male LUTS

12. mars 2020 oppdatert av: Boehringer Ingelheim

Real World Data Exploring the Practices of Primary Care Providers in the Managment of Male Lower Urinary Tract Symptoms

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.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

201

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Kentucky
      • Lexington, Kentucky, Forente stater
        • 527.87.10001 Boehringer Ingelheim Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

men

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Retrospektiv

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records
Tidsramme: 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.
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.
Tidsramme: 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.
12 months
The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms.
Tidsramme: 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.
12 months
The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).
Tidsramme: 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.
12 months
The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.
Tidsramme: 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.
12 months
The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms.
Tidsramme: 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.
12 months
The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.
Tidsramme: 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
The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview.
Tidsramme: 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.
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. mai 2016

Primær fullføring (Faktiske)

21. desember 2016

Studiet fullført (Faktiske)

21. desember 2016

Datoer for studieregistrering

Først innsendt

8. mars 2017

Først innsendt som oppfylte QC-kriteriene

8. mars 2017

Først lagt ut (Faktiske)

9. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 527.87

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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