Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
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Copenhagen, Danmark, 2100
- Rigshospitalet
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Active comparator/Yellow catheter
SpeediCath coated catheter
|
Speedicath, Intermittent catheterisation
Andre navn:
|
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Eksperimentell: NonCE marked intermittent catheter/red
|
Paris, Intermittent catheterisation
Andre navn:
|
|
Eksperimentell: NonCE marked intermittent catheter/green
|
Paris, Intermittent catheter
Andre navn:
|
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Eksperimentell: NonCE marked intermittent catheter/Blue
|
Paris, Intermittent catheter
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety
Tidsramme: During the investigation 11 Weeks per subject
|
Safety is evalueted continues while the subjects are testing the devices
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During the investigation 11 Weeks per subject
|
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Susanne Gürtler, CTM, Coloplast A/S
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CP065CC
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