Clean Intermittant Self Catheterisation: A Trial Comparing Single Use vs Reuse of Nelaton Catheters

NCT ID: NCT01404481

Last Updated: 2015-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-04-30

Brief Summary

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The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.

Detailed Description

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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

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Urinary Retention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single use group

New catheter for each Clean Intermittent Self Catheterisation (CISC), then discard.

clean intermittent self catheterisation single use vs re use

Intervention Type DEVICE

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

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.

clean intermittent self catheterisation single use vs re use

Intervention Type DEVICE

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

Interventions

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clean intermittent self catheterisation single use vs re use

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

Intervention Type DEVICE

Other Intervention Names

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Nelaton Catheters

Eligibility Criteria

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Inclusion Criteria

* over 18 years old
* CISC \> 2/day
* No current symptomatic UTI
* Willing to change catheter use method

Exclusion Criteria

* Symptomatic Urinary Tract infection despite treatment
* \<18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St George Hospital, Australia

OTHER

Sponsor Role lead

Responsible Party

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Hayley Leek

Hayley Leek CNS Urology/Continence NCA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kate Moore, A/Professor

Role: PRINCIPAL_INVESTIGATOR

St George Hospital

Dr Emmanuel Karantanis, Doctor

Role: PRINCIPAL_INVESTIGATOR

St George Hospital

Locations

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Pelvic Floor Bladder Unit St George Hospital

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 34699062 (View on PubMed)

Other Identifiers

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09/STG/176

Identifier Type: -

Identifier Source: org_study_id

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