Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000618055
Ethics application status
Approved
Date submitted
28/07/2010
Date registered
28/07/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Simple, safe and economical: In patients with continent catheterizable ileal pouch after cystectomy, sterile solution for rinsing of pouches can safely be replaced by tap water
Scientific title
Assessment of intermittent rinsing of pouches with sterile sodium chloride (NaCl) 0.9% solution or tap water in patients with continent catheterizable ileal pouch after cystectomy in terms of incidence of nitrite-positive days and urinary tract infections, quality of life and costs in a cross-over study.
Secondary ID [1] 252335 0
nil
Universal Trial Number (UTN)
U1111-1116-3127
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Continent catheterizable ileal pouches 257829 0
Urinary tract infection 257830 0
Bladder cancer 257831 0
Condition category
Condition code
Cancer 257999 257999 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with continent catheterizable ileal pouch are prospectively randomized in a two-arm crossover study. One study arm is "aseptic intermittent self catheterisation (ISC) and rinsing with sodium bicarbonate (NaCl) 0.9% solution". This study arm lasts 90 days. Every morning a dipstick urine test is done by the patient to check nitrite in urine. After that, the umbilicus is cleaned with aseptic solution. Then the pouch is catheterized with a sterile single-use catheter. After catheterizing, the poch is rinced with 3 times 60 milliliters of sterile NaCl 0.9% solution. In case of nitrite-negativity, the same procedure is repeated next morning. In case of nitrite-positivity, the same procedure is repeated at the next catheterization 4 hours later. The entire procedure takes about 15 minutes. In monthly intervals urine cultures are collected. In case of symptomatic urinary tract infection (UTI) an antibiotic therapy is prescribed. Evaluation of quality of life and costs by questionnaire.
There is washout period is one day between the two study arms of the cross-over study.
Intervention code [1] 256888 0
Treatment: Other
Comparator / control treatment
The other study arm is "hygienic ISC and rinsing with tap water". This study arm lasts 90 days. Every morning a dipstick urine test is done by the patient to check nitrite in urine. After that, the umbilicus is cleaned with tap water. Then the pouch is catheterized with a clean single-use catheter. After catheterizing, the poch is rinced with 3 times 60 milliliters of tap water. In case of nitrite-negativity, the same procedure is repeated next morning. In case of nitrite-positivity, the same procedure is repeated at the next catheterization 4 hours later. The entire procedure takes about 15 minutes. In monthly intervals urine cultures are collected. In case of symptomatic urinary tract infection (UTI) an antibiotic therapy is prescribed. Evaluation of quality of life and costs by questionnaire.
After the end of the second study arm the study is finished, no further follow-up.
Control group
Active

Outcomes
Primary outcome [1] 258859 0
The amount of nitrite-positive urine study days. Every study day with at least one nitrite-positive urine dipstick test is counted as "nitrite-positive". A study day with a negative nitrite-test in the morning is negative.
Timepoint [1] 258859 0
at baseline and then daily until the end of study
Primary outcome [2] 258860 0
urinary tranct infection by urine culture
Timepoint [2] 258860 0
at baseline and then monthly until the end of study
Primary outcome [3] 258861 0
quality of life by questionnaire
Timepoint [3] 258861 0
at baseline and 3 and 6 months after beginning of the study
Secondary outcome [1] 264984 0
costs per month of the used material of each patient are evaluated. costs include catheters, syringes, rinsing solution, aseptic solution. Not included are costs for tap water, shipment of the material and waste disposal.
Timepoint [1] 264984 0
at the end of the study
Secondary outcome [2] 264985 0
The amount and the duration of every prescribed antibiotic treatments for a symptomatic urinary tract infection (UTI) is evalutated. A symptomatic UTI is defined as a nitrite-positive urine dipstick with fever and/or abdominal pain.
Timepoint [2] 264985 0
at the end of the study

Eligibility
Key inclusion criteria
Continent catheterizable ileal pouch since 2 weeks or more
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronical urinary tract infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment outside Australia
Country [1] 2787 0
Switzerland
State/province [1] 2787 0

Funding & Sponsors
Funding source category [1] 257351 0
Hospital
Name [1] 257351 0
Department of Urology, Inselspital Bern
Country [1] 257351 0
Switzerland
Primary sponsor type
Hospital
Name
Department of Urology, Inselspital Bern
Address
Anna Seiler-Haus
Inselspital
CH-3010 Bern
Country
Switzerland
Secondary sponsor category [1] 256593 0
None
Name [1] 256593 0
Address [1] 256593 0
Country [1] 256593 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259373 0
Kantonale Ethikkommission Bern (KEK)
Ethics committee address [1] 259373 0
Ethics committee country [1] 259373 0
Switzerland
Date submitted for ethics approval [1] 259373 0
Approval date [1] 259373 0
24/10/2005
Ethics approval number [1] 259373 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31440 0
Address 31440 0
Country 31440 0
Phone 31440 0
Fax 31440 0
Email 31440 0
Contact person for public queries
Name 14687 0
Frederic Birkhaeuser
Address 14687 0
Department of Urology
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country 14687 0
Switzerland
Phone 14687 0
+41 31 632 36 41
Fax 14687 0
Email 14687 0
[email protected]
Contact person for scientific queries
Name 5615 0
Frederic Birkhaeuser
Address 5615 0
Department of Urology
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country 5615 0
Switzerland
Phone 5615 0
+41 31 632 36 41
Fax 5615 0
Email 5615 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.