Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Comparative Study of Two Different Urine Catheters.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2100
- Rigshospitalet, dep. 2112
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Monza
nonCE marked intermittent catheter
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intermittent catheterisation
다른 이름들:
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활성 비교기: control
SpeediCath coated catheter
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intermittent catheterisation
다른 이름들:
intermittent catheterisation
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Discomfort Measured on the Visual Analog Scale (VAS)
기간: 10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
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Outcome measured on a 10 cm Visual Analog Scale ranging from "no discomfort" (0cm) to "worst thinkable discomfort" (10cm).
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10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Irritation During Voiding After Catheterization
기간: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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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
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Ease of Use Measured on a 5 Point Scale: Insertion Effort
기간: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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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
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Ease of Use Measured on a 5 Point Scale: Withdrawal Effort
기간: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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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
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Visible Blood
기간: 10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1
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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
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Haematuria
기간: 2 hours after catheterisation at visits 1 and 2
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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
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Rikke Otttesen, CTM, Coloplast A/S
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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