N/A
Completed N=60
A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
Catheterization
Source: ClinicalTrials.gov NCT00799981 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Bladder Scan Measurements of Residual Urine Volume — 32.74; 34.78 Residual volume in mL — p=0.8762
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 intermittent catheterization.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bladder Scan Measurements of Residual Urine Volume |
32.74; 34.78 | 0.8762 |
| SECONDARY Number of Subjects With a Residual Volume >5mL or ≤5mL |
42; 40; 18; 20 | 0.7905 |
| SECONDARY Number of Subjects With a Residual Volume >10mL or ≤10mL |
38; 37; 22; 23 | 1.00 |
| SECONDARY Number of Subjects With a Residual Volume >30mL or ≤30mL |
19; 26; 41; 34 | — |
| SECONDARY Number of Subjects With a Residual Volume >50mL or ≤50mL |
15; 16; 45; 44 | — |
| SECONDARY Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects) |
0.75; 0.83; -0.08 | 0.0273 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00799981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.