Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Comparative Study of Two Different Urine Catheters.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Copenhagen, Danmark, 2100
- Rigshospitalet, dep. 2112
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Monza
nonCE marked intermittent catheter
|
intermittent catheterisation
Andra namn:
|
|
Aktiv komparator: control
SpeediCath coated catheter
|
intermittent catheterisation
Andra namn:
intermittent catheterisation
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Discomfort Measured on the Visual Analog Scale (VAS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Irritation During Voiding After Catheterization
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Rikke Otttesen, CTM, Coloplast A/S
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CP063CC
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .