Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000637044
Ethics application status
Not yet submitted
Date submitted
12/07/2010
Date registered
3/08/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reduce the risk of bladder infections by using a surgical stainless steel female length catheter to perform intermittent self catheterisation.
Scientific title
A comparative study assessing the incidence of acute urinary tract infection/s using the conventional silicone female length catheter compared to the redesigned surgical stainless steel catheter in female patients with a neurogenic bladder who have to perform intermittent self catheterising.
Secondary ID [1] 252306 0
Nil
Universal Trial Number (UTN)
U1111-1115-6164
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurogenic bladder with a post void residual volume of greater than 100mls 257727 0
Urinary tract infection 257816 0
Condition category
Condition code
Renal and Urogenital 257899 257899 0 0
Other renal and urogenital disorders
Infection 257987 257987 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the patients enrolled in the study must be intermittently self catheterising using the conventional female length silicone catheter.

This study is going to compare the use of a redesigned surgical stainless steel catheter to the conventional silicone catheter for intermittent self catheterising.

The patients enrolled in the study will use the surgical stainless steel catheter for 12 weeks.

The surgical stainless steel catheter will be used at the same frequency as the standard silicone catheter for self catheterising.

The surgical stainless steel catheter is a multiple use. The same catheter will be used during the 12 week trial. Patients clean the surgical stainless steel catheter with tepid water following use. No sterilising equipment is needed. The surgical stainless steel catheter has been assessed by microbiology. The assessment involed contaminating the catheter with infected urine. A swab was taken and confirmed the microbe. The catheter was cleaned with tepid tap water and the catheter was swabbed again. This swab was negative and confirmed no growth following cleaning of the catheter with tepid tap water.

The conventional silicone catheter is also multiple use. If a patient does not have a urinary tract infection, the catheter is replaced daily. If the patient has a urinary tract infection the catheter is replaced after every use.

There is one treatment group and the patients act as their own controls due to the small sample size
Intervention code [1] 256785 0
Treatment: Devices
Intervention code [2] 256879 0
Prevention
Comparator / control treatment
No control due to small sample size. The incidence of urinary tract infection over a 12 week period using the surgical stainless steel catheter will be compared to incidence of urinary tract infection during a retrospective 12 week period using the conventional silicone catheter.

The incidence of infection would have been documented for the retrospective 12 week period.
Control group
Historical

Outcomes
Primary outcome [1] 258763 0
Incidence of urinary tract infection.

If a patient is symptomatic during the 12 week study period, a urine sample is obtained for microscopy and culture to confirm the infection, then treated accordingly
Timepoint [1] 258763 0
At any point during the 12 week study period if the patient is symptomatic
Secondary outcome [1] 264820 0
Assess the potential cost reduction in the treatment of acute urinary tract infections during the 12 week trial period.

Cost:
1. Antibiotics - cost of the antibiotic will be determined retrospectively at the end of the study period. The type of antibiotic used and duration will be obtained from patient diaries, general practitioner records, continence clinic records. The hospital pharmacy will then be contacted and asked to provide the total cost of the patients antibiotic treatment.
2. Mid stream urine analysis and culture. The number of mid stream urines will be calculated at the end of the 12 week study period and the labs will be contact to provide a total cost for the mid stream urine analysis
3. General Practitioner visit as required. The number of General Practitioner visits will be calculated at the end of the 12 week study period. The patients medical centre will be contacted and ask to provide a information of the total cost of the general practitioner visits during the 12 week study period.
4. 3x Continence clinic visit. Free of charge to the patient.
Timepoint [1] 264820 0
End of 12 week study period
Secondary outcome [2] 264821 0
Comparing the cost of the Silicone Catheters compared to the Surgical Stainless Steel Catheter and the relative ancillary costs.

Costs:
1. Cost of silicone catheter is $0.36 per catheter
- $672.00 per year if self catheterising 4 times per day
2. One off charge for the stainless steel catheter $150

For this study the patient will be asked to keep a diary and document how many times they replaced their silicone catheters during the 12 week study period. The total cost will be calculated at the end of the 12 week study period
Timepoint [2] 264821 0
End of 12 week study period
Secondary outcome [3] 264822 0
Assess the ease of use and potential change in quality of life using the SF 36 quality of life questionnaire and one-on-one patient interviews
Timepoint [3] 264822 0
Baseline and end of 12 week study period
Secondary outcome [4] 264823 0
To assess the ease of cleaning and storage of the catheter and associated equipment. This will be assessed using the SF 36 quality of life questionaire and one-on-one patient interviews.

The catheter has been sujected to microbiology testing following routine washing with tepid water. No other agent is required.

Storage in a zip lock plastic bag is advised.
Timepoint [4] 264823 0
End of 12 week study period

Eligibility
Key inclusion criteria
(1) Female patients aged 16 - 80.
(2) The patient must have a neurogenic bladder and a post void residual volume > 100mls.
(3) The patient must be able to self-catheterise without assistance from a carer.
(4) There must be a history of recurrent urinary tract infections clinically associated with self-catheterisation.
Minimum age
16 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) History of urethral trauma/stricture.
(2) Inadequate upper limb dexterity to be able to self-catheterise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Approaching all patients alreadly performing self catheterisation and are under the supervision of the Continence Service, ISIS (One site One service) Centre, Southern District Health Board.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 2756 0
New Zealand
State/province [1] 2756 0
Otago

Funding & Sponsors
Funding source category [1] 257274 0
Self funded/Unfunded
Name [1] 257274 0
Country [1] 257274 0
New Zealand
Primary sponsor type
Individual
Name
Dr L J (Vic) du Plessis
Address
ISIS Centre
Wakari Hospital
Private Bag 1921
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 256516 0
None
Name [1] 256516 0
Address [1] 256516 0
Country [1] 256516 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259298 0
Lower South Regional Ethics Committee
Ethics committee address [1] 259298 0
Lower South Regional Ethics Committee
Ministry of Health
229 Moray Place
PO Box 5849
Dunedin 9054
Ethics committee country [1] 259298 0
New Zealand
Date submitted for ethics approval [1] 259298 0
24/06/2010
Approval date [1] 259298 0
Ethics approval number [1] 259298 0
LRS/10/06/023

Summary
Brief summary
This study aims to investigate the incidence of urinary tract infection in people who have a neurogenic bladder with a post void residual volume of greater than 100mls who have to self catheterise to empty their bladder properly. This study will compare the incidence of urinary tract infection using the redesigned surgical stainless steel catheter to the conventional silicone catheter. It will also assess the potential improvement in quality of life and ease of use and storage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31382 0
Address 31382 0
Country 31382 0
Phone 31382 0
Fax 31382 0
Email 31382 0
Contact person for public queries
Name 14629 0
Dr LJ (Vic) du Plessis
Address 14629 0
ISIS Centre
Wakari Hospital
Private Bag 1921
Dunedin 9016
Country 14629 0
New Zealand
Phone 14629 0
+64 21 253 1148
Fax 14629 0
+64 3 4766046
Email 14629 0
[email protected]
Contact person for scientific queries
Name 5557 0
Dr LJ (Vic) du Plessis
Address 5557 0
ISIS Centre
Wakari Hospital
Private Bag 1921
Dunedin 9016
Country 5557 0
New Zealand
Phone 5557 0
+64 21 253 1148
Fax 5557 0
+64 3 4766046
Email 5557 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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