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

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

Study Overview

• Status: Completed
• Conditions: Catheterization
• Intervention / Treatment: Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm

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.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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Borås, Sweden, SE-501 82
    • Rehabiliteringskliniken, Södra Älvsborgs Sjukhus
  • Gothenburg, Sweden, SE-413 45
    • Verksamhet Urologi, Sahlgrenska Universitetssjukhuset
  • Lund, Sweden, SE-221 85
    • Clinical Research and Trial Centre, Lund University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Coloplast SpeediCath Compact 7 cm; Astra Tech POBE 10 cm
Experimental: 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.	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.; Other Names: Coloplast SpeediCath Compact 7 cm; Astra Tech POBE 10 cm
Experimental: 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.	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.; Other Names: Coloplast SpeediCath Compact 7 cm; Astra Tech POBE 10 cm
Experimental: 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.	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.; Other Names: Coloplast SpeediCath Compact 7 cm; Astra Tech POBE 10 cm
Experimental: 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.	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.; Other Names: Coloplast SpeediCath Compact 7 cm; Astra Tech POBE 10 cm
Experimental: 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.	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.; Other Names: Coloplast SpeediCath Compact 7 cm; Astra Tech POBE 10 cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Ulf Malmqvist, MD, PhD, Assoc.Prof., Clinical Research and Trial Centre, Lund University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: November 28, 2008
• First Submitted That Met QC Criteria: November 28, 2008
• First Posted (Estimate): December 1, 2008

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: YA-LOF-0015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No