Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Comparative Study of Two Different Urine Catheters.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Copenhagen, Denemarken, 2100
- Rigshospitalet, dep. 2112
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Monza
nonCE marked intermittent catheter
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intermittent catheterisation
Andere namen:
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Actieve vergelijker: control
SpeediCath coated catheter
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intermittent catheterisation
Andere namen:
intermittent catheterisation
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Discomfort Measured on the Visual Analog Scale (VAS)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Irritation During Voiding After Catheterization
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Rikke Otttesen, CTM, Coloplast A/S
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CP063CC
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