Status:
COMPLETED
A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
Lead Sponsor:
Wellspect HealthCare
Conditions:
Catheterization
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
A study comparing a 10 cm catheter with a 7 cm catheter in a group of female patients who, on a routine bases, empty their bladder using urinary catheters, by measuring residual urine after intermitte...
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00799981
Start Date
November 1 2008
End Date
March 1 2009
Last Update
May 18 2021
Active Locations (3)
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1
Rehabiliteringskliniken, Södra Älvsborgs Sjukhus
Borås, Sweden, SE-501 82
2
Verksamhet Urologi, Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, SE-413 45
3
Clinical Research and Trial Centre, Lund University Hospital
Lund, Sweden, SE-221 85