Home Urodynamics Testing for Neurogenic Bladder

Overseen By Denise Juhr, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Non-iOS phone

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators have developed a novel pressure monitoring device called a 'cystoelastometer' that connects to a drainage end ofastandard 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 in measuring bladder pressure compared to the gold standard urodynamics that are performed in the clinic or hospital. This study will assess the patients and care givers ability and experience using the cystoelastometer device in a home setting.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, so it's best to ask the study team for guidance.

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

Research shows that home monitoring of bladder pressure can help identify high bladder pressures early, which is important for preventing kidney problems in people with neurogenic bladder. A similar device, the cystomanometer, has been used successfully for home bladder pressure monitoring, suggesting that the Cystoelastometer might also be effective for this purpose. ^{1 2 3 4 5}

How does home urodynamics testing differ from other treatments for neurogenic bladder?

Home urodynamics testing is unique because it allows patients to monitor their bladder pressures at home using a device, which can help identify high bladder pressures early and prevent kidney damage. This approach is different from traditional methods that require clinical visits for bladder pressure monitoring. ^{2 5 6 7 8}

Research Team

Christopher S Cooper, MD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for patients with neurogenic bladder who manage their condition using clean intermittent catheterization and are seen at the University of Iowa Pediatric Urology Clinic. They should have had a recent urodynamic study and no changes in management. Those without an iOS-compatible phone cannot participate.

Inclusion Criteria

I have a neurogenic bladder and use catheters for management, seen at the University of Iowa.

You have not had any changes in your medical treatment.

You recently had a test called urodynamic study.

Exclusion Criteria

Your phone is not compatible with iOS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the cystoelastometer device at least twice a day for two weeks to monitor bladder pressure and volume at home

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cystoelastometer

Trial Overview The trial is testing a new device called 'cystoelastometer' designed for home use to monitor bladder pressure, which could be an alternative to clinical urodynamics tests. The focus is on assessing how well patients and caregivers can use this device at home.

Participant Groups

Group I: Neurogenic Bladder Patient Experimental Treatment 1 Intervention

Patients with neurogenic bladder

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Urodynamic utilization in the adult spina bifida patient: An institutional review. [2022]

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

Home monitoring of bladder pressure and volume in individuals with spinal cord injury and multiple sclerosis. [2019]

3. India pubmed.ncbi.nlm.nih.gov

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

4. Brazil pubmed.ncbi.nlm.nih.gov

Early treatment improves urodynamic prognosis in neurogenic voiding dysfunction: 20 years of experience. [2020]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Neurogenic detrusor overactivity: comparison between complete and incomplete spinal cord injury patients. [2008]

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

The reproducibility of urodynamic studies of neurogenic bladders in spinal cord injury. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Video-urodynamic characteristics and management in complete cervical and thoracic spinal cord injury patients]. [2014]