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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Catheterization

Intervention / Treatment
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* Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study was designed as a randomised, single blind, cross-over study to eliminate bias. Every subject was catheterisized with both 7 cm and 10 cm long catheters.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AABB<br>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<br>* 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.<br>* Other names: Astra Tech POBE 10 cm;|
| Experimental: ABAB<br>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<br>* 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.<br>* Other names: Astra Tech POBE 10 cm;|
| Experimental: ABBA<br>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<br>* 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.<br>* Other names: Astra Tech POBE 10 cm;|
| Experimental: BAAB<br>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<br>* 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.<br>* Other names: Astra Tech POBE 10 cm;|
| Experimental: BABA<br>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<br>* 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.<br>* Other names: Astra Tech POBE 10 cm;|
| Experimental: BBAA<br>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<br>* 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.<br>* Other names: Astra Tech POBE 10 cm;|

What is the study measuring?
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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. |