A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
A Multi Centre, Single-blind, Randomized, Cross-over Study Comparing Two Female Catheters With Different Length in Terms of Residual Urine After Intermittent Catheterization
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study personnel will conduct three bladder scans after each catheterization in order to obtain the mean residual urine volume. Each patient will catheterize herself two times with each product, i.e. a total of four catheterizations.
Diagnosis and BMI will be collected at visit 1 to assess whether the residual urine volume differs between these subgroups.
The hypothesis that the mean residual volumes were equal when using the 7 and the 10 centimeter catheters was tested by means of the Wilcoxon signed rank test.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Borås, Sverige, SE-501 82
- Rehabiliteringskliniken, Södra Älvsborgs Sjukhus
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Gothenburg, Sverige, SE-413 45
- Verksamhet Urologi, Sahlgrenska Universitetssjukhuset
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Lund, Sverige, SE-221 85
- Clinical Research and Trial Centre, Lund University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Provision of signed informed consent
- Female subjects aged 18 years and over
- Experienced users of CIC with a minimum of one month of use
- Practice CIC a minimum of 1 time per day
- Practice CIC with female catheters with a maximum length of 20 cm
- Perform self-catheterization
- Sufficient hand function to be able to open and handle catheter packages
- Use catheters with Ch 10, 12 or 14
Exclusion Criteria:
- Pregnancy
- Ongoing symptomatic UTI
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrolment or randomisation of treatment in the present study
- Participation in another clinical study during the study period
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: AABB
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 7 cm then 10 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Andre navn:
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Eksperimentell: ABAB
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 10 cm then 7 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Andre navn:
|
|
Eksperimentell: ABBA
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 10 cm then 10 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Andre navn:
|
|
Eksperimentell: BAAB
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then 7 cm then 7 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Andre navn:
|
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Eksperimentell: BABA
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then then 7 cm then 10 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Andre navn:
|
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Eksperimentell: BBAA
A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then 10 cm then 7 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order. |
Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Bladder Scan Measurements of Residual Urine Volume
Tidsramme: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Measurements were performed with the bladder scan BVI 3000. The primary outcome variable was average residual urine volume (mL) calculated from repetitive bladder scans performed after each catheterization. Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. |
Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Subjects With a Residual Volume >5mL or ≤5mL
Tidsramme: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. At least 2 hours had to pass between 2 catheterizations.
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Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. At least 2 hours had to pass between 2 catheterizations.
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Number of Subjects With a Residual Volume >10mL or ≤10mL
Tidsramme: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
|
Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Number of Subjects With a Residual Volume >30mL or ≤30mL
Tidsramme: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Number of Subjects With a Residual Volume >50mL or ≤50mL
Tidsramme: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
|
Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
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Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)
Tidsramme: Question asked minutes after catheterization.
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After each catheterization the study nurse will ask the subject whether it feels as if the bladder is completely emptied or not. 0=No and 1=Yes. |
Question asked minutes after catheterization.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ulf Malmqvist, MD, PhD, Assoc.Prof., Clinical Research and Trial Centre, Lund University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- YA-LOF-0015
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