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
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Kentucky
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Lexington、Kentucky、アメリカ
- 527.87.10001 Boehringer Ingelheim Investigational Site
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：回顧
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.
時間枠：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.
時間枠：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).
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。