A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization

Catheterization Clinical Trial

Official title:

A Multi Centre, Single-blind, Randomized, Cross-over Study Comparing Two Female Catheters With Different Length in Terms of Residual Urine After Intermittent Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799981
• Other study ID #: YA-LOF-0015
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2021
• Source: Wellspect HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheterization

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Sweden	Rehabiliteringskliniken, Södra Älvsborgs Sjukhus	Borås
Sweden	Verksamhet Urologi, Sahlgrenska Universitetssjukhuset	Gothenburg
Sweden	Clinical Research and Trial Centre, Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder Scan Measurements of Residual Urine Volume	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.
Secondary	Number of Subjects With a Residual Volume >5mL or =5mL		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.
Secondary	Number of Subjects With a Residual Volume >10mL or =10mL		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.
Secondary	Number of Subjects With a Residual Volume >30mL or =30mL		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.
Secondary	Number of Subjects With a Residual Volume >50mL or =50mL		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.
Secondary	Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)	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.