Urinary RetentionNCT01284361
Comparison of Two Intermittent Urinary Catheters
A study testing 30 cm Intermittent Catheter and 40 cm Intermittent Catheter in people with Urinary Retention, run by Hollister Incorporated at 4 sites in United States.
Trial summary
This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Retention
- What is being tested?
- 30 cm Intermittent Catheter and 40 cm Intermittent Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2010to Aug 2011
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is male and at least 18 years of age
- is self-catheterizing at least 3 times a day
- has been performing catheterizations for at least 2 months
- wheelchair bound
- is able to use a size 12 or 14 French straight catheter
- is willing and able to follow the study protocol and Investigator's instructions
- is, in the opinion of the Investigator, qualified to participate
Who cannot join
- has cognitive impairments that preclude completion of study protocol
- cannot communicate as determined by the Investigator
- has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results
- has a symptomatic urinary tract infection determined by interview
- has a retracted penis
- has participated in a study during the previous 30 days involving catheterization
- has been diagnosed with an enlarged prostate
- has urethral strictures, false passages, or urethral obstruction
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Shepherd Center and Crawford Research Institute
Atlanta, Georgia, 30309-1465
Restored Images
Kansas City, Missouri, 64119
Vanderbilt University
Nashville, Tennessee, 37235
Mark Drug Medical Supply
Wheeling, Illinois, 60090
About this study
Official title: User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter
This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.
Read the detailed description
- is male and at least 18 years of age.
- is self-catheterizing at least 3 times a day.
- has been performing catheterizations for at least 2 months.
- is wheelchair bound.
- is able to use a size 12 or 14 French straight catheter.
- is willing and able to follow the study protocol and Investigator's instructions.
- is in the opinion of the Investigator, qualified to participate.
- Conditions
- Urinary Retention
- Being tested
- 30 cm Intermittent Catheter, 40 cm Intermittent Catheter
- Keywords
- intermittent catheter, preference
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 cm Intermittent CatheterDevice
Also called Apogee Intermittent Catheter
Randomized cross-over
40 cm Intermittent CatheterDevice
Also called Apogee Intermittent Catheter
randomized cross-over
| Study group | Role | What they receive |
|---|---|---|
| 30 cm Intermittent Catheter | Experimental | Intervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design. Receives: Device: 30 cm Intermittent Catheter |
| 40 cm Intermittent Catheter | Active comparator | Active comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design. Receives: Device: 40 cm Intermittent Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants
Percentage of participants that preferred the 40 cm catheter
Measured: 1 week
Secondary outcomes (1)
Assessment of Ease of Use Characteristics
Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the "top" two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 2011
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rita Kaurs, MSHSA MT NMT, Study director, Hollister Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284361
- Sponsor's protocol ID
- 4875-I
- Status last verified
- Dec 2016
- First submitted
- 21 Jan 2011
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Published in Spinal Cord (2013) 51, 772-775
Publications
Costa JA, Menier M, Doran TJ, Kohler TS. Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization. Spinal Cord. 2013 Oct;51(10):772-5. doi: 10.1038/sc.2013.76. Epub 2013 Jul 30.
PubMed 23896665Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
PubMed 34699062
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Preference Study to Compare a 40cm Intermittent Catheter to a 30cm Intermittent Catheter
- ClinicalTrials.gov ID
- NCT01284361
- Acronym / sponsor ID
- 4875-I
- Conditions
- Urinary Retention
- Keywords
- intermittent catheter, preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Posted 1 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters. Subjects enrolled in the study will be randomized to order of catheter use. Individual participation will consist of approximately 1 week of product use. The null hypothesis to be tested is there no difference between catheters.
Detailed description
- is male and at least 18 years of age.
- is self-catheterizing at least 3 times a day.
- has been performing catheterizations for at least 2 months.
- is wheelchair bound.
- is able to use a size 12 or 14 French straight catheter.
- is willing and able to follow the study protocol and Investigator's instructions.
- is in the opinion of the Investigator, qualified to participate.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 cm Intermittent Catheter | Experimental | Device: 30 cm Intermittent CatheterIntervention was the test of a 30 cm catheter compared to standard commercial 40 cm catheter in a cross-over design. |
| 40 cm Intermittent Catheter | Active comparator | Device: 40 cm Intermittent CatheterActive comparator 40 cm commercial catheter was compared to experimental 30 cm catheter in a cross-over design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- is male and at least 18 years of age
- is self-catheterizing at least 3 times a day
- has been performing catheterizations for at least 2 months
- wheelchair bound
- is able to use a size 12 or 14 French straight catheter
Key exclusion criteria (8 listed)
- has cognitive impairments that preclude completion of study protocol
- cannot communicate as determined by the Investigator
- has an existing medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate or in the interpretation of the results
- has a symptomatic urinary tract infection determined by interview
- has a retracted penis
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 |
|---|---|---|
| 30 cm Intermittent CatheterAlso: Apogee Intermittent CatheterRandomized cross-over | Device | 30 cm Intermittent Catheter |
| 40 cm Intermittent CatheterAlso: Apogee Intermittent Catheterrandomized cross-over | Device | 40 cm Intermittent Catheter |
Primary outcome
Percentage of Participants
Time frame: 1 week
Percentage of participants that preferred the 40 cm catheter
1 secondary outcome
Assessment of Ease of Use Characteristics
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23896665Costa JA, Menier M, Doran TJ, Kohler TS. Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterization. Spinal Cord. 2013 Oct;51(10):772-5. doi: 10.1038/sc.2013.76. Epub 2013 Jul 30.
- Derived from this study: PubMed 34699062Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.
- Catheter length preference in wheelchair-using men who perform routine clean intermittent catheterizationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Published in Spinal Cord (2013) 51, 772-775
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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.
Rita Kaurs, MSHSA MT NMT study director
Hollister Incorporated
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 cm Intermittent Catheter and 40 cm Intermittent Catheter in people with Urinary Retention, run by Hollister Incorporated at 4 sites in United States.
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 7 inclusion and 8 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 Dec 2016). 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?
Percentage of Participants (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284361, which also lists 2 linked publications.
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 1 Feb 2017; AzTrials last refreshed its copy on 1 Nov 2026.