Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction

Surgery
Bladder health/function
Online since 12 July 2024, updated 3 days ago

About this trial

The aim of the study is to assess the feasibility and safety of a novel system for percutaneous measurement of bladder pressure. The system allows for a minimally invasive procedure and high-quality r...

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    ≥ 3 months
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have hemophilia or other clotting disorders that cause bleeding diathesis

    What’s involved

    Type

    Observational

    Details

    The aim of the study is to assess the feasibility and safety of a novel system for measurement of bladder pressure. The system allows for a minimally invasive procedure and high-quality recordings with a higher than conventional sampling rate and synchronization. The pressure sensor system has potential for being developed into a low-cost method with mass production. In persons with spinal cord injury and neurogenic bladder dysfunction, measurement of pressure in the bladder (cystometry) is mandatory to evaluate risk factors and assess treatment options. This novel system consists of a micro electro mechanical system (MEMS) integrated in a hollow flexible tube made out of biocompatible material. Recording from this sensor catheter is transmitted to specialized electronic and digital devices for processing. Due to a sensor catheter with a diameter less than 1.0 mm, it is possible to perform transurethral cystometry using a simple minimally invasive technique. The study goal is to compare the simultaneous measurement of the conventional water perfused system compared to a novel pressure sensor system during cystometry. produce high-quality recordings with a higher than conventional sampling rate. The study will include a sample of convenience of up to 40 subjects. The pressure will be recorded simultaneously with conventional and novel pressure recording system in the bladder. Subjects will be examined for any subjective or objective adverse events. The simultaneous recording with the novel and the conventional method will provide a direct comparison of simultaneous recording of pressure between the two methods. Subjects will be examined for subjective or objective adverse events. The sample size is too small for comparison of validity of the two methods in clinical practice. However, the study should be able to conclude on reliability. Thus, pressure measurements will be assessed with both methods during cystometry in up to 40 subjects. Based on the technical specifications, we expect these measurements to be almost identical and thus reliable. The study is not intended to give conclusive results on the comparison between conventional water perfused recording and the novel MEMS pressure system. However, results from this initial study will be the basis for further studies with sufficient power to validate conventional versus novel MEMS technique.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    General health

    Mental health and psychosocial factors

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Jun 2022
    • Organisation
    • Sunnaas Rehabilitation Hospital
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Jun 2022
    • Organisation
    • Sunnaas Rehabilitation Hospital

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more