Bladder Pressure Monitoring Device for Neurogenic Bladder

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Christopher Cooper

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Novel External Device for neurogenic bladder?

Research shows that a new portable device for bladder pressure monitoring can help track bladder pressure in patients with neurogenic bladder, similar to traditional methods. Another study developed a home-use device for bladder pressure monitoring, indicating potential benefits for managing neurogenic bladder. ^{1 2 3 4 5}

Is the bladder pressure monitoring device safe for humans?

The research on bladder pressure monitoring devices, including the cystomanometer and other novel devices, primarily focuses on their use in patients with neurogenic bladder. While specific safety data for humans is not detailed, these studies suggest that the devices are being developed and tested for safe use in monitoring bladder pressure. ^{1 2 4 5 6}

How does the bladder pressure monitoring device for neurogenic bladder differ from other treatments?

This treatment is unique because it involves a portable device that allows for dynamic bladder pressure monitoring at home, unlike traditional methods that require hospital visits. The device can be attached to a catheter, records bladder pressure, and transmits data wirelessly to a smartphone, making it more convenient and accessible for continuous monitoring. ^{1 2 4 6 7}

Research Team

Chris Cooper, MD

Principal Investigator

MD

Eligibility Criteria

This trial is for individuals who have been diagnosed with neurogenic bladder and are already scheduled to undergo urodynamics testing as part of their standard care. There are no specific exclusion criteria mentioned, so it appears open to all patients meeting the inclusion conditions.

Inclusion Criteria

I am scheduled for a bladder function test as part of my usual care.

I have been diagnosed with a neurogenic bladder.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Urodynamics Testing

Participants undergo standard urodynamics testing with the novel pressure monitoring device attached to the urinary catheter

During UDS testing

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

Treatment Details

Interventions

• Novel External Device

Trial Overview The study is evaluating a new pressure monitoring device that attaches to urinary catheters. The goal is to see if this novel device can measure bladder pressure accurately when compared with the established method of urodynamics testing.

Participant Groups

Group I: Neurogenic Bladder Patients Experimental Treatment 1 Intervention

Patients with neurogenic bladder undergoing urodynamics testing

Who Is Running the Clinical Trial?

Christopher Cooper

Lead Sponsor

Trials

2

Recruited

150+

Findings from Research

A new portable dynamic bladder pressure monitoring device was developed and tested on 45 patients with neurogenic bladder due to spinal cord injury, showing good reliability with an intra-class correlation coefficient of 0.852.

The device provided comparable results to traditional urodynamics devices, indicating it can effectively monitor bladder pressure without significant differences in volume perfusion evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing of a New Portable Device for Dynamic Bladder Pressure Monitoring. Liu, L., Zhao, K., Chen, F., et al.[2019]

The cystomanometer, a new device for home bladder pressure monitoring, was tested with 14 patients over two weeks, showing initial success in data transmission to smartphones and hospital servers.

Despite its promising functionality, over 50% of the devices experienced breakage, highlighting a significant durability issue that needs to be addressed for future use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a home use cystomanometer in patients with a neurogenic bladder. Cooper, CS., Bonnett, MA., Ortman, CE., et al.[2023]

The micturition alert device effectively monitors bladder volume in dogs, showing a strong correlation between bladder fullness and the device's warning unit, which can alert users when the bladder reaches a predetermined volume of 150 mL.

This device is designed to assist patients with neurogenic bladders by providing timely alerts for bladder fullness, making it a simple, cost-effective, and user-friendly solution that warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Micturition alert device dedicated to neurogenic bladders]. Wang, J., Hou, C., Zhang, W., et al.[2008]

The cystomanometer (CM) and cystoelastometer (CEM) devices demonstrated strong accuracy in measuring bladder pressure and volume, correlating well with traditional urodynamic studies (UDS) in a study of 36 and 42 patients, respectively.

These devices allow for wireless data transmission to smartphones, potentially enhancing home monitoring for patients with neurogenic bladder, although their effectiveness in patient use outside clinical settings still needs to be validated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurogenic bladder monitoring using the cystomanometer and cystoelastometer. Cooper, CS., Steinberg, RL., Thomas, LJ., et al.[2021]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Testing of a New Portable Device for Dynamic Bladder Pressure Monitoring. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Pilot study of a home use cystomanometer in patients with a neurogenic bladder. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Frequency of patient-reported UTIs is associated with poor quality of life after spinal cord injury: a prospective observational study. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Micturition alert device dedicated to neurogenic bladders]. [2008]

5. India pubmed.ncbi.nlm.nih.gov

Follow-up urodynamics in patients with neurogenic bladder. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Suburothelial Bladder Contraction Detection with Implanted Pressure Sensor. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Neurogenic bladder monitoring using the cystomanometer and cystoelastometer. [2021]