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Real World Data on Management of Male LUTS

2020年3月12日 更新者：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.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

201

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Kentucky
      • Lexington、Kentucky、美国
        • 527.87.10001 Boehringer Ingelheim Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

取样方法

概率样本

研究人群

men

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：队列
  • 时间观点：追溯

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.
大体时间：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.
大体时间：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).
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boehringer Ingelheim

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年5月19日

初级完成 (实际的)

2016年12月21日

研究完成 (实际的)

2016年12月21日

研究注册日期

首次提交

2017年3月8日

首先提交符合 QC 标准的

2017年3月8日

首次发布 (实际的)

2017年3月9日

研究记录更新

最后更新发布 (实际的)

2020年3月26日

上次提交的符合 QC 标准的更新

2020年3月12日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 527.87

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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