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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device that measures bladder pressure in individuals with neurogenic bladder, a condition where the nerves controlling the bladder malfunction. The researchers aim to determine if this Novel External Device provides results comparable to the standard urodynamics test, which assesses bladder function in holding and releasing urine. This trial suits those already scheduled for urodynamics testing as part of their regular care. Individuals with neurogenic bladder undergoing this testing might be eligible to participate. As an unphased trial, this study offers a chance to contribute to innovative research that could enhance future diagnostic options.

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 prior data suggests that this bladder pressure monitoring device is safe for neurogenic bladder patients?

Research has shown that the new device for checking bladder pressure is very safe. Studies found that patients were satisfied and did not experience any serious side effects. In a two-year study, patients reported comfort and satisfaction with the device. Another study showed regular use and high satisfaction among users. Overall, the device appears safe and well-liked by those who have used it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The novel external device for neurogenic bladder is unique because it offers a non-invasive way to monitor bladder pressure. Most treatments for neurogenic bladder involve medications or catheterization to manage symptoms, but this device aims to provide real-time data without the need for invasive procedures. Researchers are excited because it could improve patient comfort and potentially offer better management of bladder function by giving more immediate feedback on bladder pressure changes.

What evidence suggests that this device is effective for neurogenic bladder?

Research has shown that many treatments using nerve stimulation hold promise for treating neurogenic bladder. In one study, 56.5% of patients experienced significant improvement in symptoms such as frequent urination. Another study found that electrical stimulation of the muscles reduced urinary symptoms and improved quality of life. Additionally, a separate study reported that 79% of patients had a major decrease in episodes of sudden urgency to urinate after two years. This trial will evaluate a novel external device for managing neurogenic bladder symptoms, which could prove effective based on these findings. ^{1 2 4 5 6}

Who Is on the Research Team?

Chris Cooper, MD

Principal Investigator

MD

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4739974/

Neuromodulation in neurogenic bladder - PMC

This study found that test phase success rate of 56.5%. They found that test phase outcomes correlated best with symptoms, as patients with urgency-frequency or ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11271381/

Effects of external neuromuscular electrical stimulation in ...

The present study revealed that the NMES was effective in reducing urinary symptoms and improving PFMS, QoL, sexual function, PSI, and patient ...

3.

auajournals.org

auajournals.org/doi/10.1097/JU.0000000000004328

Two-Year Efficacy and Safety Outcomes of the Pivotal ...

Ninety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥50% reduction in urgency urinary ...

4.

nature.com

nature.com/articles/s41585-025-00998-9

Efficacy of the Revi system in treating urgency urinary ...

Therapy response at 24 months, defined as ≥50% reduction in UUI episodes, was reported in 79% of these patients. High satisfaction and patient ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0090429523009378

A Multicenter Study Evaluating the FREquency of Use and ...

The Avation device demonstrates promising efficacy in treating adults with overactive bladder and urge urinary incontinence.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12433157/

Effect of a novel implantable tibial nerve stimulation system ...

In a pig OAB model, the device maintained stable placement and function, improved bladder capacity by 24.4%, and showed no significant inflammatory response.