Pain-perception During Outpatient cystoscopy-a Prospective Controlled Study
At an academic tertiary referral center, patients with pelvic floor dysfunction, scheduled for outpatient cystoscopy or urodynamic testing will be asked to participate in the study. Patients will be called one day after the examination and will be asked about pain and their general state of health.
The purpose of this study it to investigate pain perception in urogynecologic patients during outpatient cystoscopy and compare it with pain perception during outpatient urodynamic. The investigators will also investigate the difference between anticipated and actual pain perception. The investigators will test the null hypothesis that there is no difference in patients´ pain perception between outpatient cystoscopy and urodynamic testing. The secondary hypothesis will be that there is no difference between patients´ anticipated amount of pain and the actually experienced pain during cystoscopy and urodynamic testing.
According to power calculation, a sample size of 52 patients per group will be needed to detect a 2 cm difference in pain scores on the VAS - judged as a clinically significant difference - with 95% power and a two-sided significance level of 0.05.
Exclusion criteria are: age ≤ 18 years, insufficient ability to understand German, pregnancy and the participation in another clinical study at the same time.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Vienna、オーストリア、1090
- Medical University Vienna
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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:
- women undergoing cystoscopy or urodynamic testing at an academic tertiary referral center.
Exclusion Criteria:
- age ≤ 18 years
- insufficient ability to understand German
- pregnancy
- participation in another clinical study at the same time
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
コホートと介入
グループ/コホート |
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urogynecologic patients undergoing outpatient cystoscopy
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urogynecologic patients undergoing outpatient-urodynamics
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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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subjective pain perception immediately after examination as measured by a standard visual analog scale
時間枠：immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
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patients are assessed at three points in time:
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immediately after examination (zero to ten minutes after completing cystoscopy or urodynamics)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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difference between anticipated pain and actual pain perception
時間枠：immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
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immediately before and immediately after the examination (zero to ten minutes after undergoing examination)
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協力者と研究者
捜査官
- 主任研究者：Wolfgang Umek, Prof、Medical University Vienna Austria
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。