- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01142115
Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Comparative Study of Two Different Urine Catheters.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Copenhagen, Danemark, 2100
- Rigshospitalet, dep. 2112
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Monza
nonCE marked intermittent catheter
|
intermittent catheterisation
Autres noms:
|
Comparateur actif: control
SpeediCath coated catheter
|
intermittent catheterisation
Autres noms:
intermittent catheterisation
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Discomfort Measured on the Visual Analog Scale (VAS)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Irritation During Voiding After Catheterization
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Rikke Otttesen, CTM, Coloplast A/S
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CP063CC
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