Urinary RetentionSURENCT01404481
Clean Intermittant Self Catheterisation: A Trial Comparing Single Use vs Reuse of Nelaton Catheters
An observational study of Urinary Retention, run by St George Hospital, Australia at 1 site in Australia.
Trial summary
The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention
- What is being tested?
- clean intermittent self catheterisation single use vs re use
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Continence clinic, community patients, hospital patients
Who may be able to join
- over 18 years old
- CISC > 2/day
- No current symptomatic UTI
- Willing to change catheter use method
Who cannot join
- Symptomatic Urinary Tract infection despite treatment
- <18 years old
Trial locations and contacts
1 site in 1 country.
Australia1 site
Pelvic Floor Bladder Unit St George Hospital
Sydney, New South Wales, 2217
About this study
Official title: Clean Intermittant Self Catheterisation: A Randomised Control Trial Comparing Single Use vs Reuse of Nelaton Catheters
The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.
Read the detailed description
Patients with voiding dysfunction and chronic urinary retention are taught the technique Clean Intermittent Self Catheterisation (CISC) by specialist Nurse Continence Advisors.
For several decades, patients have been taught to catheterise using a "clean" technique where they rinse their catheter under tap water and store the catheter in a sterile solution (e.g. Milton). The catheter is re-used for up to one week. The risk of urinary tract infection (UTI) was known to be minimal (and certainly much less than having a permanent indwelling catheter).
Recently, the Therapeutics Goods Administration has issued a guideline that CISC catheters should be "single-use items" but no data to support this guideline appears to have been collected.
The aim of this project is to assess the incidence of urinary tract infection (UTI) when comparing single-use catheters with re-use of catheters for CISC, and to determine the cost differences between the two methods.
- Conditions
- Urinary Retention
- Being tested
- clean intermittent self catheterisation single use vs re use
- Keywords
- Urinary retention, CISC, Single use, Re use
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clean intermittent self catheterisation single use vs re useDevice
Also called Nelaton, Catheters
Over the 16 week period all patient will participate in 8 weeks of single use cathetersation and 8 weeks of re use catheterisation. The study is a randomised control crossover trial
| Study group | Role | What they receive |
|---|---|---|
| Single use group | New catheter for each Clean Intermittent Self Catheterisation (CISC), then discard. Receives: Device: clean intermittent self catheterisation single use vs re use | |
| Re use of catheters group | Use same catheter for 1week- Cleaning with sunlight liquid soap, air dry or dry with lint free towel, store in a snap lock bag.
Discard catheter and snap lock bag at end of each week. Receives: Device: clean intermittent self catheterisation single use vs re use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Urinary Tract Infection
Urine specimens are sent at 4 weekly intervals over 16 weeks to check for Urinary tract infection
Measured: 16 weeks
Secondary outcomes (1)
Economic Cost
Difference in econimic cost of single use Catheterisation and re use catheterisation and the impact on the patient
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George Hospital, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayley Leek, St George Hospital, Australia
- Investigators
- Kate Moore, A/Professor, Principal investigator, St. George's Hospital, LondonDr Emmanuel Karantanis, Doctor, Principal investigator, St. George's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404481
- Sponsor's protocol ID
- 09/STG/176
- Acronym
- SURE
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2011
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Prieto 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 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clean Intermittant Self Catheterisation: A Randomised Control Trial Comparing Single Use vs Reuse of Nelaton Catheters
- ClinicalTrials.gov ID
- NCT01404481
- Acronym / sponsor ID
- SURE / 09/STG/176
- Conditions
- Urinary Retention
- Keywords
- Urinary retention, CISC, Single use, Re use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- St George Hospital, AustraliaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.
Detailed description
Patients with voiding dysfunction and chronic urinary retention are taught the technique Clean Intermittent Self Catheterisation (CISC) by specialist Nurse Continence Advisors.
For several decades, patients have been taught to catheterise using a "clean" technique where they rinse their catheter under tap water and store the catheter in a sterile solution (e.g. Milton). The catheter is re-used for up to one week. The risk of urinary tract infection (UTI) was known to be minimal (and certainly much less than having a permanent indwelling catheter).
Recently, the Therapeutics Goods Administration has issued a guideline that CISC catheters should be "single-use items" but no data to support this guideline appears to have been collected.
The aim of this project is to assess the incidence of urinary tract infection (UTI) when comparing single-use catheters with re-use of catheters for CISC, and to determine the cost differences between the two methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single use group | – | Device: clean intermittent self catheterisation single use vs re useNew catheter for each Clean Intermittent Self Catheterisation (CISC), then discard. |
| Re use of catheters group | – | Device: clean intermittent self catheterisation single use vs re useUse same catheter for 1week- Cleaning with sunlight liquid soap, air dry or dry with lint free towel, store in a snap lock bag. Discard catheter and snap lock bag at end of each week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Continence clinic, community patients, hospital patients
Key inclusion criteria (4 listed)
- over 18 years old
- CISC > 2/day
- No current symptomatic UTI
- Willing to change catheter use method
Key exclusion criteria (2 listed)
- Symptomatic Urinary Tract infection despite treatment
- <18 years old
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 |
|---|---|---|
| clean intermittent self catheterisation single use vs re useAlso: Nelaton, CathetersOver the 16 week period all patient will participate in 8 weeks of single use cathetersation and 8 weeks of re use catheterisation. The study is a randomised control crossover trial | Device | Re use of catheters group, Single use group |
Primary outcome
Rate of Urinary Tract Infection
Time frame: 16 weeks
Urine specimens are sent at 4 weekly intervals over 16 weeks to check for Urinary tract infection
1 secondary outcome
Economic Cost
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- 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.
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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.
Kate Moore, A/Professor principal investigator
St. George's Hospital, London
Dr Emmanuel Karantanis, Doctor principal investigator
St. George's Hospital, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Retention, run by St George Hospital, Australia at 1 site in Australia.
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 4 inclusion and 2 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 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Urinary Tract Infection (time frame: 16 weeks). 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 NCT01404481, which also lists 1 linked publication.
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 24 Jul 2015.