Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Comparative Study of Two Different Urine Catheters.
調査の概要
詳細な説明
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast has developed a new intermittent catheter. In this investigation this new test catheter will be compared with SpeediCath by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.
Healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Copenhagen、デンマーク、2100
- Rigshospitalet, dep. 2112
-
-
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
説明
Inclusion Criteria:
- 18 years or older
- Male
- signed informed Consent,
- Neg. urine multistix
Exclusion Criteria:
- Abnormalities,
- diseases or surgical procedures performed in the lower urinary-tract
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Monza
nonCE marked intermittent catheter
|
intermittent catheterisation
他の名前：
|
|
アクティブコンパレータ：control
SpeediCath coated catheter
|
intermittent catheterisation
他の名前：
intermittent catheterisation
他の名前：
|
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 |
|---|---|---|
|
Discomfort Measured on the Visual Analog Scale (VAS)
時間枠：10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
|
Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
|
10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Irritation During Voiding After Catheterization
時間枠：10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
|
After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no. Yes - they experienced irritation. No - they did not experience irritation. |
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
|
|
Ease of Use Measured on a 5 Point Scale: Insertion Effort
時間枠：10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
|
After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy |
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
|
|
Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
時間枠：10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
|
After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been. There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy |
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
|
|
Visible Blood
時間枠：10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
|
Visual blood observed on the catheter or in the urine in connection to catheterization. The nurse who conducted the catheterization could answer yes or no as follows: Yes = visible blood observed. No = no visible blood observed. |
10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
|
|
Haematuria
時間枠：2 hours after catheterisation at visits 1 and 2
|
Negative or positive result on a multistix urin analysis. Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter. |
2 hours after catheterisation at visits 1 and 2
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Rikke Otttesen, CTM、Coloplast A/S
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 (見積もり)
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
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