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Trial registered on ANZCTR


Registration number
ACTRN12610000878077
Ethics application status
Not yet submitted
Date submitted
16/10/2010
Date registered
19/10/2010
Date last updated
19/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Microtip and 7-channel catheter for urethral pressure measurements: a prospective comparative study
Scientific title
Measuring the human urethral pressure with the standard Microtip catheter and the new 7-channel catheter and assessment of agreement of the two catheters in a prospective comparative study
Secondary ID [1] 252885 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiological urethral pressure in healthy human volunteers 258417 0
Condition category
Condition code
Renal and Urogenital 258584 258584 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The urethral pressure is measured with the standard urethral pressure catheter Microtip. After this measurement the urethral pressure is measured again with the new 7-channel catheter. The intervention is a part of a urodynamic evaluation for which the women are scheduled. Each measurement is taken once in each patient.

The microtip catheter is has 2 sensors (one in the bladder, one in the urethra) and is withdrawn through the urethra using a mechanical puller at a constant speed. Measurement take about 1 minute.

The 7-channel catheter has 7 individual sensors at 5 mm distance between each of them, size 8 French, flexible. It is not withdrawn. Measurement take about 1 minute.
Intervention code [1] 257413 0
Diagnosis / Prognosis
Comparator / control treatment
The control of the new 7-channel catheter is the standard Microtip catheter.
Control group
Active

Outcomes
Primary outcome [1] 259428 0
Urethral pressure measured in cmH20.
Timepoint [1] 259428 0
At the measurement. There is only one measurement.
Secondary outcome [1] 265976 0
Adverse events:
- pains: pains are assessed by questioning (visual analogue scale VAS).
Timepoint [1] 265976 0
- pains: assessment before, during and immediately after the procedure.

Eligibility
Key inclusion criteria
A continuous series of women scheduled for a urodynamic evaluation.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Urinary tract infection.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2976 0
Switzerland
State/province [1] 2976 0

Funding & Sponsors
Funding source category [1] 257855 0
Hospital
Name [1] 257855 0
Department of Urology, University of Bern
Address [1] 257855 0
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country [1] 257855 0
Switzerland
Primary sponsor type
Hospital
Name
Department of Urology, University of Bern
Address
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country
Switzerland
Secondary sponsor category [1] 257082 0
None
Name [1] 257082 0
Address [1] 257082 0
Country [1] 257082 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
This study has not been judged by an official ethics committee, which has a HREC Number. At this time around 2002, this kind of small studies was discussed and ethically judged and eventually approved by the staff of the Department of Urology, University of Bern.

The purpose of this study was to compare the standard microtip catheter with the new 7-channel catheter in terms of accuracy and safety measuring the urethral pressure. Both measurements are very similar, easy to do and non-invasive. The catheter in placed into the urethra, like a foley catheter. The hypothesis was, that the measurement with the 7-channel catheter was even accurate and less uncomfortable for patients, because it was not withdrawn. With about 1 minute both measurements were short. Based on the experience with the microtip catheter, no side effects, like pain, were expected
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31784 0
Address 31784 0
Country 31784 0
Phone 31784 0
Fax 31784 0
Email 31784 0
Contact person for public queries
Name 15031 0
Frederic Birkhaeuser
Address 15031 0
Department of Urology
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country 15031 0
Switzerland
Phone 15031 0
+41 31 632 36 41
Fax 15031 0
Email 15031 0
frederic.birkhaeuser@insel.ch
Contact person for scientific queries
Name 5959 0
Frederic Birkhaeuser
Address 5959 0
Department of Urology
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country 5959 0
Switzerland
Phone 5959 0
+41 31 632 36 41
Fax 5959 0
Email 5959 0
frederic.birkhaeuser@insel.ch

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary