Normal Values of Urodynamic Pressures Using eSense Catheters
Research type
Research Study
Full title
Normal Values of Urodynamic Pressures Using e-Sense® Catheters
IRAS ID
357469
Contact name
Andrew Gammie
Contact email
Sponsor organisation
Laborie Medical Technologies
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Urodynamic pressure measurements are currently normally transmitted from the patient to the transducer via water-filled catheters. Over the decades, a large amount of data has resulted in a guideline for the normal range of pressures.
Recently, catheter-tip measurements have come onto the market, using either air-filled balloons or electronic sensors, that will have different pressure readings, if only because they record the pressure at the position of the catheter tip. Studies in air-filled catheters have suggested that there may be other factors contributing to the measurements made for example interaction of the bladder wall with the transducer or poor transmission in an empty bladder. It is therefore appropriate that the new e-Sense® catheters have this same assessment compared with a water-filled line.
Urodynamic measurements are made during the process of filling the bladder with saline. Pressures are measured within the bladder, via urethral catheter, and outside the bladder but within the abdomen, normally via a rectal catheter. The action of the bladder muscle can be inferred from any rise in the pressure within the bladder relative to the surrounding abdominal pressure.
The pressures will change according to the position of the patient – supine, seated or standing. It will thus be necessary to measure pressures in each position and at different bladder volumes.
Subjects who are referred to undergo Urodynamics will be recruited to participate in the study. Initial resting pressures will be measured/recorded in supine, seated and standing positions using both catheters at the time (dual-catheterized) for each subject. The study will collect various urodynamic pressure values at regular intervals during bladder filling. The pressures before filling will be compared with the pressures collected during bladder filling to determine normal pressure value ranges. Urethral pressures will also be measured with both catheter systems and compared.
REC name
South West - Frenchay Research Ethics Committee
REC reference
25/SW/0058
Date of REC Opinion
18 Jun 2025
REC opinion
Further Information Favourable Opinion