None listed
Conditions
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the measurement with the 7-channel catheter was even accurate and less uncomfortable for patients, because it was not withdrawn.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
Interventions
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The microtip catheter is has 2 sensors (one in the bladder, one in the urethra) and is withdrawn through the urethra using a mechanical puller at a constant speed.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 t
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 The microtip catheter is has 2 sensors (one in the bladder, one in the urethra) and is withdrawn through the urethra using a mechanical puller at a constant speed.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 It is not withdrawn.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.
Sponsors
Department of Urology, University of Bern
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
A continuous series of women scheduled for a urodynamic evaluation.
Exclusion criteria
Urinary tract infection.
Outcome results
None listed