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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called a Cystomanometer, which measures bladder pressure in individuals with neurogenic bladder—a condition where the nerves controlling the bladder malfunction. The device attaches to standard catheters used at home, and the trial evaluates its ease and effectiveness for patients and caregivers outside a hospital setting. Participants must have a neurogenic bladder diagnosis and regularly use catheters. As an unphased trial, this study provides participants the opportunity to contribute to innovative research that could enhance daily life for those with neurogenic bladder.

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 prior data suggests that this device is safe for patients with a neurogenic bladder?

Research has shown that the cystomanometer is a new device designed to assist people with nerve-related bladder issues. This tool accurately measures bladder pressure and liquid volume. Tests in medical settings have confirmed its reliability.

Although specific safety data from these studies is unavailable, the device is designed to work with regular urinary catheters, suggesting it might be as safe as the catheters patients already use. Overall, the potential for improved monitoring and care is promising, but discussing any concerns or questions with a doctor is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cystomanometer device for neurogenic bladder because it offers a new way to monitor bladder function. Unlike current treatments like medications or catheters that mainly manage symptoms, this device provides real-time data on bladder pressure and function. This approach could lead to more personalized treatment plans and improve the quality of life for patients with neurogenic bladder by precisely targeting their needs. By offering insights into bladder dynamics, the Cystomanometer might revolutionize how we understand and treat this condition.

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

Research has shown that the cystomanometer, used by participants in this trial, accurately measures bladder pressure and volume. Studies have found that this device provides precise readings compared to standard clinical methods. For patients with neurogenic bladder, it offers a promising way to monitor their condition at home. Early results indicate that the device functions effectively and can send data to a smartphone, simplifying health tracking for patients. Using this technology at home appears both feasible and beneficial for ongoing care. ^{1 6 7 8 9}

Who Is on the Research Team?

Christopher S Cooper, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32005418/

Neurogenic bladder monitoring using the cystomanometer ... The CM and CEM devices provide accurate bladder pressure and volume measurements. The potential for improved patient monitoring and care is promising.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04128709?cond=%22Urinary%20Bladder,%20Neurogenic%22&viewType=Table&rank=6

Measurement of Bladder Pressure With a Novel External ... The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters that are used by patients with a neurogenic bladder ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1477513124005394

Experiences and barriers with home bladder manometry in ... Conclusions. Home bladder manometry is a feasible and beneficial way for neurogenic bladder patients to monitor their bladder pressures and volumes at home.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35717327/

Pilot study of a home use cystomanometer in patients with ... Results: Fourteen patients with neurogenic bladder were enrolled. Discussion: The cystomanometer initially functioned well and transmitted data to a smartphone ...

5. advanced.onlinelibrary.wiley.com advanced.onlinelibrary.wiley.com/doi/10.1002/adhm.202502811

Recent Technological Advances in Monitoring and ... This review summarizes recent progress in advanced urotechnologies, focusing on bladder monitoring and neuromodulation approaches, advanced ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1477513119304383

Neurogenic bladder monitoring using the cystomanometer ... The CM and CEM devices provide accurate bladder pressure and volume measurements. The potential for improved patient monitoring and care is promising.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04128709?cond=%22Urinary%20Bladder,%20Neurogenic%22&aggFilters=status:not%20rec&rank=1

Measurement of Bladder Pressure With a Novel External ... The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters that are used by patients with a neurogenic bladder ...

8. spuonline.org spuonline.org/abstracts/2019/45.cgi

SPU: Neurogenic Bladder Monitoring Using the ... The novel CM and CEM devices provide accurate bladder pressure and volume measurements. The potential for better patient monitoring and care is promising.

9. 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 ...