Urinary Bladder, NeurogenicNCT03456089
Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing
A study testing Urodynamics Testing in people with Urinary Bladder, Neurogenic and Urodynamics, run by Christopher Cooper at 1 site in United States.
Trial summary
The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Urinary Bladder, Neurogenic, Urodynamics
- What is being tested?
- Urodynamics Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2018to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- must have diagnosed neurogenic bladder
- undergoing urodynamics testing as part of routine clinical care
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Iowa Hospitals and Clinics, Department of Urology
Iowa City, Iowa, 52242
About this study
The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.
Read the detailed description
For patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. This monitoring is currently done by in-office urodynamics testing (UDS). This testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions.
This study utilizes a novel pressure monitoring device which is portable and hooks to the end of a standard urinary catheter. The investigators will be investigating if this device can achieve similar pressure measurements as UDS. The investigators hope is that this device will provide similar measurements to UDS, and can be developed as a home bladder-pressure monitoring tool.
This study will enroll children with neurogenic bladder who are currently undergoing UDS as part of their regular care. The measurements will be taken as part of the standard UDS protocol (with insertion of the UDS catheter) and will then be compared to the values obtained with UDS testing.
- Conditions
- Urinary Bladder, Neurogenic, Urodynamics
- Being tested
- Urodynamics Testing
- Keywords
- urodynamics, neurogenic, bladder
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamics TestingDiagnostic test
Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance
| Study group | Role | What they receive |
|---|---|---|
| Neurogenic Bladder Patients | Other | Patients with neurogenic bladder undergoing urodynamics testing Receives: Diagnostic Test: Urodynamics Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Pressure
Pressure of the bladder at bladder capacity
Measured: During UDS testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start15 Apr 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, NeurogenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher Cooper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Cooper, University of Iowa
- Investigators
- Chris Cooper, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456089
- Sponsor's protocol ID
- 201702822
- Status last verified
- Jan 2026
- First submitted
- 28 Feb 2018
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing
- ClinicalTrials.gov ID
- NCT03456089
- Acronym / sponsor ID
- 201702822
- Conditions
- Urinary Bladder, Neurogenic, Urodynamics
- Keywords
- urodynamics, neurogenic, bladder
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christopher CooperUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.
Detailed description
For patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. This monitoring is currently done by in-office urodynamics testing (UDS). This testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions.
This study utilizes a novel pressure monitoring device which is portable and hooks to the end of a standard urinary catheter. The investigators will be investigating if this device can achieve similar pressure measurements as UDS. The investigators hope is that this device will provide similar measurements to UDS, and can be developed as a home bladder-pressure monitoring tool.
This study will enroll children with neurogenic bladder who are currently undergoing UDS as part of their regular care. The measurements will be taken as part of the standard UDS protocol (with insertion of the UDS catheter) and will then be compared to the values obtained with UDS testing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurogenic Bladder Patients | Other | Diagnostic Test: Urodynamics TestingPatients with neurogenic bladder undergoing urodynamics testing |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- must have diagnosed neurogenic bladder
- undergoing urodynamics testing as part of routine clinical care
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urodynamics TestingUrodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance | Diagnostic test | Neurogenic Bladder Patients |
Primary outcome
Bladder Pressure
Time frame: During UDS testing
Pressure of the bladder at bladder capacity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Urinary Bladder, Neurogenic
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
Chronic Kidney Diseases, Bladder Dysfunction
Active, not recruitingObservational study
Qualitative Assessment of the Impact of TTNS on QOL and Participation
Neurogenic Bladder, Urinary Retention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Cooper, MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urodynamics Testing in people with Urinary Bladder, Neurogenic and Urodynamics, run by Christopher Cooper at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Pressure (time frame: During UDS testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.