Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000344998
Ethics application status
Not yet submitted
Date submitted
28/03/2011
Date registered
1/04/2011
Date last updated
1/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparatve study between self catheterisation with a silicone catheter and a stainless steel catheter assessing bladder infection rate in female patients who are self catheterising.
Scientific title
Comparative Multicentre trial assessing the incidence of urinary tract infections using the conventional silicone catheter with a stainless steel catheter for intermittent self catheterising in patients who have a neurogenic bladder and a post void residual volume of >100mls
Secondary ID [1] 259872 0
This study has not been previously registered with another registry
Universal Trial Number (UTN)
U1111-1120-3101
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurogenic bladder with post void residual volumes of greater than 100mls 265461 0
Condition category
Condition code
Renal and Urogenital 265616 265616 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an extenson of a previous study registration number:
ACTRN12610000637044. The previous study was titled "A comparative study between the use of the conventional silicone catheter and the surgical stainless steel catheter". The previous study only enrolled 10 participants to trial the catheter. The participants who were involved in the study reported that the surgical stainless steel catheter improved bladder emtpying, reduced time to void, did not need lubrication and it was easier to carry around.

This present study has been designed to further evaluate incidence of infection, ease of use and continence specific quality of life in 50 female pateints comparing a conventional silicone catheter with a surgical stainless steel catheter. Patients wil be asked to catheterise for 3 months using the silicone catheter followed by 3 months with the stainless steel catheter, catheterising at their usual frequency ie 3-4 times per day
Intervention code [1] 264293 0
Treatment: Devices
Comparator / control treatment
No control due to sample numbers
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262400 0
Incidence of urinary tract infection. Any patient developing symptoms during the trial period will be investigated for urinary tract infection with microscopy and culture to confirm infection and treated accordingly
Timepoint [1] 262400 0
At any time during the 6 months study period if the patient is symptomatic
Secondary outcome [1] 273707 0
Comparing Ease of use using a questionnaire
Timepoint [1] 273707 0
End of study period
Secondary outcome [2] 273708 0
Assessing continence specific quality of life changes usng a questionnaire
Timepoint [2] 273708 0
End of study period
Secondary outcome [3] 273711 0
Evaluate effectiveness simplified cleaning techniques compared to costly replacement of silicone catheters using a questionnaire and performing urinalysis if symptomatic with UTI
Timepoint [3] 273711 0
End of study period

Eligibility
Key inclusion criteria
(1) Female patients aged 16 - 75.
(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 associated with self-catheterisation.
Minimum age
16 Years
Maximum age
75 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.
(3) No history of infections in the preceding 14 days.

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 who are self catheterising and are the supervision of continence services in New Zealand
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
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3319 0
New Zealand
State/province [1] 3319 0

Funding & Sponsors
Funding source category [1] 264748 0
Self funded/Unfunded
Name [1] 264748 0
Country [1] 264748 0
New Zealand
Primary sponsor type
Individual
Name
Dr LJ (Vic) du Plessis
Address
ISIS Centre
Private Bag 1921
Dunedin
Country
New Zealand
Secondary sponsor category [1] 263874 0
Individual
Name [1] 263874 0
Mr Dave Solomon
Address [1] 263874 0
82 Glenpark Ave
Mornington
Dunedin
Country [1] 263874 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266734 0
Multi-region Ethics Committee
Ethics committee address [1] 266734 0
PO Box 5013
Wellington
Ethics committee country [1] 266734 0
New Zealand
Date submitted for ethics approval [1] 266734 0
01/04/2011
Approval date [1] 266734 0
Ethics approval number [1] 266734 0

Summary
Brief summary
This study has been designed is to compare the incidence of urinary tract infections (UTI) in 50 female patients who need to self catheterise to properly empty their bladders.
Participants in this study will be monitored for a 3 month period for frequency of UTIs, ease of use and continence specific quality of life while using the Nelaton silicone catheter, followed by a 3 month study period using a surgical stainless steel catheter assessing the same parameters for intermittent self catheterising.
During the 6 month study peroid, participants will be asked to keep a urinary diary and they will be monitored closely for urinary tract infection (UTI). If a participant develops symptoms of UTI, a urine sample will be obtained and sent for urinalysis. If positive they will be commenced on appriopriate antibiotics and a decision will be made whether the patient needs to be withdrawn from the study.
At the end of the study, each participant will be asked to complete a patient satisfaction survery and continence specific quality of life questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32399 0
Address 32399 0
Country 32399 0
Phone 32399 0
Fax 32399 0
Email 32399 0
Contact person for public queries
Name 15646 0
Dr LJ (Vic) du Plessis
Address 15646 0
ISIS Centre
Private Bag 1921
Dunedin
Country 15646 0
New Zealand
Phone 15646 0
0064 212531148
Fax 15646 0
0064 3 4766046
Email 15646 0
Vic.DuPlessis@southerndhb.govt.nz
Contact person for scientific queries
Name 6574 0
Dr LJ (Vic) du Plessis
Address 6574 0
ISIS Centre
Private Bag 1921
Dunedin
Country 6574 0
New Zealand
Phone 6574 0
0064 212531148
Fax 6574 0
0064 3 4766046
Email 6574 0
Vic.DuPlessis@southerndhb.govt.nz

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

Documents added manually
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