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Completed

NCT Number: NCT00799981

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

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.

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Key information

Conditions

Catheterization

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rehabiliteringskliniken, Södra Älvsborgs Sjukhus, Borås, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A=SpeediCath Compact 7 cm and B=POBE 10 cm

Device

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 names: Coloplast SpeediCath Compact 7 cm, Astra Tech POBE 10 cm

Primary outcomes

  1. Bladder Scan Measurements of Residual Urine Volume

    Time frame: 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.

    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.

Secondary outcomes

  1. Number of Subjects With a Residual Volume >5mL or ≤5mL

    Time frame: 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.

  2. Number of Subjects With a Residual Volume >10mL or ≤10mL

    Time frame: 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.

  3. Number of Subjects With a Residual Volume >30mL or ≤30mL

    Time frame: 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.

  4. Number of Subjects With a Residual Volume >50mL or ≤50mL

    Time frame: 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.

  5. Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)

    Time frame: Question asked minutes after catheterization.

    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.

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 1, 2008
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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