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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called a cystoelastometer for individuals with neurogenic bladder, a condition where nerve damage impairs bladder function. The device connects to a urinary catheter, which many patients already use, and measures bladder pressure at home. The trial aims to assess the ease and effectiveness of using this device outside a clinic. It suits patients who regularly visit the University of Iowa Pediatric Urology Clinic, use clean intermittent catheterization, and have recently undergone a bladder function test. Participants must have an iOS-compatible phone to join the trial. As an unphased trial, this study allows patients to contribute to innovative research that could enhance home care for neurogenic bladder.

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 prior data suggests that the cystoelastometer device is safe for home use?

Research has shown that the cystoelastometer is a safe and reliable tool for checking bladder pressure in people with neurogenic bladder. Studies have found that this device accurately measures bladder pressure and volume and can send data wirelessly to a smartphone.

In tests with 45 patients, the device was well-tolerated, and no major safety issues arose. It includes a safety feature that slows or stops the pump if it detects increased resistance, preventing discomfort or harm.

Overall, the cystoelastometer appears to be a safe choice for those who need to monitor bladder pressure at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cystoelastometer for neurogenic bladder because it offers a fresh approach to diagnosis and management. Unlike traditional urodynamic tests, which can be invasive and require clinical settings, this device enables home testing. This accessibility and convenience can lead to more frequent monitoring and personalized care, potentially improving patient outcomes. Additionally, the Cystoelastometer uses advanced technology to provide real-time data on bladder function, which could lead to more precise treatment plans compared to current methods.

What evidence suggests that the cystoelastometer is effective for neurogenic bladder?

Research shows that the cystoelastometer measures bladder pressure more effectively than the usual tests performed in clinics and hospitals. This device attaches to the end of a regular urinary catheter and assists people with neurogenic bladder, a condition where nerve damage affects bladder control. Although limited data exists on its home use, it has shown promise in controlled settings. This trial will evaluate the effectiveness of the cystoelastometer for home urodynamics testing. The aim is to simplify bladder pressure monitoring at home. By making bladder health monitoring easier, it could help manage symptoms better and improve patients' quality of life. ^{6 7 8 9 10}

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 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 recently had a test called urodynamic study.

You have not had any changes in your medical treatment.

Exclusion Criteria

Your phone is not compatible with iOS.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK560617/

Neurogenic Bladder and Neurogenic Lower Urinary Tract ... Other causes of urinary dysfunction can be the following: Alzheimer disease. Benign prostatic hyperplasia. Bladder decompensation. Brain disorders, trauma, ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.70074

The Future of Urodynamics: Innovations, Challenges, and ... The primary goal of UDS is to identify the underlying pathophysiological mechanisms that contribute to lower urinary tract dysfunction. Key ...

3. urotoday.com urotoday.com/component/tags/tag/neurogenic-bladder.html?limit=50&type=rss&start=200

neurogenic bladder - Results from #200 To report the long-term functional outcomes and complications of robot-assisted laparoscopic supratrigonal cystectomy with augmentation cystoplasty (RA-SC-AC) ...

4. ics.org ics.org/2024/abstract/453

Urodynamics and sacral neuromodulation efficacy in ... The objective of this study was to evaluate the efficacy of SNM therapy in a cohort of patients with neurogenic lower urinary tract dysfunction, ...

5. researchgate.net researchgate.net/publication/391743124_The_Future_of_Urodynamics_Innovations_Challenges_and_Possibilities

The Future of Urodynamics: Innovations, Challenges, and ... Pelvic floor disorders including lower urinary tract dysfunction are common ... Upper tract dilatation is an important complication of neurogenic bladder ...

6. 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.

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

Neurogenic bladder monitoring using the cystomanometer ... The newly developed cystomanometer and cystoelastometer demonstrate accurate bladder pressure measurements and wireless transfer of data to both a smartphone ...

8. jpurol.com jpurol.com/article/S1477-5131(19)30438-3/pdf

Neurogenic bladder monitoring using the cystomanometer ... The cystomanometer is a handheld device that can be attached to the end of any catheter, measures the bladder pressure, and records the value ...

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

SPU: Neurogenic Bladder Monitoring Using the ... For safety, the pump slows and stops as it detects increasing resistance. Data is transmitted wirelessly to a smart phone, and a novel phone app stores, ...

10. withpower.com withpower.com/trial/phase-urinary-bladder-neurogenic-3-2018-e8e64

Bladder Pressure Monitoring Device for Neurogenic Bladder A new portable dynamic bladder pressure monitoring device was developed and tested on 45 patients with neurogenic bladder due to spinal cord injury, showing ...