CatheterizationNCT00799981
A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
A study testing A=SpeediCath Compact 7 cm and B=POBE 10 cm in people with Catheterization, run by Wellspect HealthCare at 3 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Catheterization
- What is being tested?
- A=SpeediCath Compact 7 cm and B=POBE 10 cm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSweden
- Study dates
- Nov 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Rehabiliteringskliniken, Södra Älvsborgs Sjukhus
Borås, SE-501 82
Verksamhet Urologi, Sahlgrenska Universitetssjukhuset
Gothenburg, SE-413 45
Clinical Research and Trial Centre, Lund University Hospital
Lund, SE-221 85
About this study
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
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.
Read the 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.
- Conditions
- Catheterization
- Being tested
- A=SpeediCath Compact 7 cm and B=POBE 10 cm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A=SpeediCath Compact 7 cm and B=POBE 10 cmDevice
Also called Coloplast SpeediCath Compact 7 cm, Astra Tech 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.
| Study group | Role | What they receive |
|---|---|---|
| AABB | Experimental | 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. Receives: Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm |
| ABAB | Experimental | 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. Receives: Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm |
| ABBA | Experimental | 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. Receives: Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm |
| BAAB | Experimental | 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. Receives: Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm |
| BABA | Experimental | 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. Receives: Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm |
| BBAA | Experimental | 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. Receives: Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (5)
Number of Subjects With a Residual Volume >5mL or ≤5mL
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Question asked minutes after catheterization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulf Malmqvist, MD, PhD, Assoc.Prof., Principal investigator, Clinical Research and Trial Centre, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799981
- Sponsor's protocol ID
- YA-LOF-0015
- Status last verified
- Apr 2021
- First submitted
- 28 Nov 2008
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00799981
- Acronym / sponsor ID
- YA-LOF-0015
- Conditions
- Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Nov 2008 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| AABB | Experimental | Device: A=SpeediCath Compact 7 cm and B=POBE 10 cmA=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. |
| ABAB | Experimental | Device: A=SpeediCath Compact 7 cm and B=POBE 10 cmA=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. |
| ABBA | Experimental | Device: A=SpeediCath Compact 7 cm and B=POBE 10 cmA=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. |
| BAAB | Experimental | Device: A=SpeediCath Compact 7 cm and B=POBE 10 cmA=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. |
| BABA | Experimental | Device: A=SpeediCath Compact 7 cm and B=POBE 10 cmA=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. |
| BBAA | Experimental | Device: A=SpeediCath Compact 7 cm and B=POBE 10 cmA=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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A=SpeediCath Compact 7 cm and B=POBE 10 cmAlso: Coloplast SpeediCath Compact 7 cm, Astra Tech POBE 10 cmCatheterization 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. | Device | AABB, ABAB, ABBA, BAAB, BABA, BBAA |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)
Time frame: Question asked minutes after catheterization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Malmqvist, MD, PhD, Assoc.Prof. principal investigator
Clinical Research and Trial Centre, Lund University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A=SpeediCath Compact 7 cm and B=POBE 10 cm in people with Catheterization, run by Wellspect HealthCare at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.