Clinical trial NCT06445426: Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
Official title: Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Urinary Bladder, Neurogenic
Keywords: Urodynamics
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: SINTEF MiNaLab
name: University of Oslo
First posted: 2024-06-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from patients with chronic spinal cord injury (SCI) admitted for cystometry at Sunnaas Hospital´s urodynamic laboratory. All subjects will have a clinical indication for cystometry.

Brief summary: The aim of this study is to assess the feasibility and safety of a novel system for percutaneous measurement of bladder pressure. This system enables minimally invasive procedures and high-quality recordings, offering a sampling rate and synchronization surpassing traditional methods. The pressure sensor system has the potential to be developed into a low-cost method suitable for mass production. The study will include a sample of convenience of up to 40 subjects. Pressure will be recorded simultaneously in the bladder using both the conventional and novel pressure recording systems. This simultaneous recording method will provide a direct comparison of pressure recordings between the two systems. Subjects will be examined for any subjective or objective adverse events.

Detailed description: The aim of this study is to assess the feasibility and safety of a novel system for measurement of bladder pressure. The system facilitates a minimally invasive procedure, enabling high-quality recordings with a sampling rate and synchronization that surpass conventional standards. The pressure sensor system has potential to be developed into a low-cost method with mass production. In patients 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 the conventional and novel pressure recording system in the urinary bladder. The simultaneous recording with the novel and the conventional method will provide a direct comparison of simultaneous recording of pressure between the two systems. Patients 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. Given the technical specifications, the measurements are expected to be nearly identical, thereby ensuring reliability. The study is not intended to provide 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.

Eligibility criteria: Inclusion Criteria:

* Documented traumatic or non-traumatic spinal cord injury
* Documented neurogenic bladder dysfunction by previous cystometry
* More than 3 months after injury
* Subject is able to communicate in Norwegian
* Subject is able and willing to sign informed consent
* Subject is able to complete all study requirements

Exclusion Criteria:

* History or evidence of previous urological or lower abdominal abnormalities from disease or surgery
* Use of anti-platelet or anti-coagulant other than low molecular weight heparin or acetylsalicylic acid which cannot be discontinued
* Symptomatic urinary tract infection
* Hemophilia or other clotting disorders that cause bleeding diathesis
* Any condition or situation, which, in the investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study

Primary outcomes:
measure: Bladder pressure
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
measure: Advert effects monitoring and resolution
timeFrame: 72 hours
Locations:
city: Oslo
country: Norway
facility: Sunnaas Rehabilitation Hospital
state: Nesoddtangen
Study officials:
References: