- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01292941
Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.
Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat 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.
55 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.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
-
Copenhagen, Danmark, 2100
- Rigshospitalet
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
• ≥18 years
- Male
- Signed informed consent
- Negative urine stix (erythrocytes, leucocytes and nitrite)
Exclusion Criteria:
- • Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Active comparator/Yellow catheter
SpeediCath coated catheter
|
Speedicath, Intermittent catheterisation
Andre navne:
|
Eksperimentel: NonCE marked intermittent catheter/red
|
Paris, Intermittent catheterisation
Andre navne:
|
Eksperimentel: NonCE marked intermittent catheter/green
|
Paris, Intermittent catheter
Andre navne:
|
Eksperimentel: NonCE marked intermittent catheter/Blue
|
Paris, Intermittent catheter
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Discomfort during catheterisation measured by VAS-scale (0-10)
Tidsramme: 10 measurements in an 11 week period. 10 min after each catheterisation
|
A subject is assesing a VAS scale after each catheterisation.
|
10 measurements in an 11 week period. 10 min after each catheterisation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Safety
Tidsramme: During the investigation 11 Weeks per subject
|
Safety is evalueted continues while the subjects are testing the devices
|
During the investigation 11 Weeks per subject
|
Discomfort during urination post catheterisation
Tidsramme: 10 measurements in an 11 week period. 10 min after each catheterisation
|
Subjects own assesment.
Yes or no can be answered to discomfort during urination post catheterisation
|
10 measurements in an 11 week period. 10 min after each catheterisation
|
Haematuria
Tidsramme: 10 measurements in an 11 week period. 10 min after each catheterisation
|
Urine test after each catheterisation, and measured on a urine stix
|
10 measurements in an 11 week period. 10 min after each catheterisation
|
Handling during insertion, withdrawal
Tidsramme: 10 measurements in an 11 week period. 10 min after each catheterisation
|
Ease of use assessed by nurses, measured on a 5 point scale
|
10 measurements in an 11 week period. 10 min after each catheterisation
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Susanne Gürtler, CTM, Coloplast A/S
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CP065CC
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