Cystomanometer Device for Neurogenic Bladder

Overseen By Denise Juhr, BS

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

Duration: 2 weeks

50 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 that are used by patients with a neurogenic bladder on daily clean intermittent catheterization. The device has already been demonstrated to be accurate compared to the gold standard in clinic urodynamics. This study will assess the patients and care givers ability and experience using the device in a home setting.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Cystomanometer for neurogenic bladder?

Research shows that the cystomanometer, a device for home bladder pressure monitoring, has been developed to help patients with neurogenic bladder. It allows for frequent and convenient monitoring, which can improve management and outcomes, similar to how increased monitoring has benefited other chronic conditions like diabetes. ^{1 2 3 4 5}

Is the Cystomanometer device safe for human use?

The Cystomanometer device has been developed for home bladder pressure monitoring in patients with neurogenic bladder, and it includes safety features like slowing and stopping the pump when it detects resistance, suggesting it has been designed with safety in mind. ^{1 3 4 6 7}

How does the cystomanometer treatment for neurogenic bladder differ from other treatments?

The cystomanometer is unique because it allows patients to monitor their bladder pressure at home, unlike traditional methods that require hospital visits. This device can be attached to any catheter and records bladder pressure, which helps in managing the condition more effectively by providing real-time data. ^{1 3 4 5 6}

Research Team

Christopher S Cooper, MD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for individuals with a neurogenic bladder, which means their bladder muscles don't work properly due to nerve damage. Participants must be using urinary catheters regularly. There are no specific exclusion criteria mentioned, so it seems open to anyone who fits the inclusion condition.

Inclusion Criteria

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

Treatment

Participants use the novel bladder pressure monitoring device at home at least twice a day

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after using the device

4 weeks

Treatment Details

Interventions

• Cystomanometer

Trial Overview The study is testing a new device called Cystomanometer that measures bladder pressure and can be attached to standard urinary catheters. The focus of this trial is on how patients and caregivers manage with the device when used at home.

Participant Groups

Group I: Neurogenic Bladder Patient Experimental Treatment 1 Intervention

Patients with neurogenic bladder

Who Is Running the Clinical Trial?

Christopher Cooper

Lead Sponsor

Trials

2

Recruited

150+

Findings from Research

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]

Home monitoring of bladder pressure in 11 children with myelomeningocele using a pressure gauge proved to be a simple and cost-effective method, providing accurate data over an average of 4.7 months.

The home-measured bladder pressures were consistent with laboratory cystometric pressures, indicating that this method can effectively track changes in bladder function and potentially alert caregivers to significant health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home bladder pressure monitoring in children with myelomeningocele. Andros, GJ., Hatch, DA., Walter, JS., et al.[2006]

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 (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 wireless implantable micromanometer (WIMM) system is designed for chronic bladder pressure sensing, which is crucial for improving urodynamics and neuromodulation therapies, potentially enhancing bladder control.

The WIMM operates with low power consumption (average current draw of 9 μA), allowing for at least 24 hours of operation after a 4-hour recharge, making it a practical and efficient solution for real-time bladder pressure monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless, Ultra-Low-Power Implantable Sensor for Chronic Bladder Pressure Monitoring. Majerus, SJ., Garverick, SL., Suster, MA., et al.[2020]

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 new cystometric parameter, pressure adjusted area under curve ratio (PAUC), along with its derivatives, showed superior predictive power for high-grade hydronephrosis and new scar formation in myelomeningocele patients, based on a study of 115 subjects followed for an average of 6 years.

These parameters provide a more comprehensive assessment of intravesical pressure during the filling phase, making them potentially valuable tools for identifying patients at risk of kidney damage due to neurogenic bladder dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study assessing average detrusor pressure garnered from area under a urodynamic curve: Evaluation of clinical outcomes. Tiryaki, S., Tekin, A., Avanoglu, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Home bladder pressure monitoring in children with myelomeningocele. [2006]

3. Australia pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

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

Wireless, Ultra-Low-Power Implantable Sensor for Chronic Bladder Pressure Monitoring. [2020]

6. China pubmed.ncbi.nlm.nih.gov

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

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

A pilot study assessing average detrusor pressure garnered from area under a urodynamic curve: Evaluation of clinical outcomes. [2022]