A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
NCT ID: NCT00799981
Last Updated: 2021-05-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2008-11-30
2009-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Every subject was catheterisized with both 7 cm and 10 cm long catheters.
OTHER
DOUBLE
The investigator was blinded to which catheter was used.
Study Groups
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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.
A=SpeediCath Compact 7 cm and B=POBE 10 cm
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.
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.
A=SpeediCath Compact 7 cm and B=POBE 10 cm
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.
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.
A=SpeediCath Compact 7 cm and B=POBE 10 cm
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.
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.
A=SpeediCath Compact 7 cm and B=POBE 10 cm
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.
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.
A=SpeediCath Compact 7 cm and B=POBE 10 cm
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.
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.
A=SpeediCath Compact 7 cm and B=POBE 10 cm
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.
Interventions
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A=SpeediCath Compact 7 cm and B=POBE 10 cm
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Wellspect HealthCare
INDUSTRY
Responsible Party
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Principal Investigators
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Ulf Malmqvist, MD, PhD, Assoc.Prof.
Role: PRINCIPAL_INVESTIGATOR
Clinical Research and Trial Centre, Lund University Hospital
Locations
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Rehabiliteringskliniken, Södra Älvsborgs Sjukhus
Borås, , Sweden
Verksamhet Urologi, Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Clinical Research and Trial Centre, Lund University Hospital
Lund, , Sweden
Countries
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Other Identifiers
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YA-LOF-0015
Identifier Type: -
Identifier Source: org_study_id
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