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Enrolling by invitationNCT03456089Updated Jun 17, 2026

Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

An interventional study of Urodynamics Testing in Urinary Bladder, Neurogenic and Urodynamics, sponsored by Christopher Cooper. Enrolling by invitation at 1 site in United States. Open to participants aged 1 Year to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by Christopher Cooper · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
1 Year to 99 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Urinary Bladder, Neurogenic
  • Urodynamics

Keywords

  • urodynamics
  • neurogenic
  • bladder
03

Who can participate

Ages eligible
1 Year to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • must have diagnosed neurogenic bladder
  • undergoing urodynamics testing as part of routine clinical care

Exclusion criteria

Exclusion Criteria:

-None

04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Neurogenic Bladder Patients

    Patients with neurogenic bladder undergoing urodynamics testing

    Diagnostic Test: Urodynamics Testing

Interventions

  • Diagnostic testUrodynamics Testing

    Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance

05

What researchers measure

Primary outcomes

  1. Bladder Pressure

    Pressure of the bladder at bladder capacity

    Time frame: During UDS testing

06

Study locations

1 site
  • University of Iowa Hospitals and Clinics, Department of Urology
    Iowa City, Iowa 52242, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03456089
Lead sponsor
Christopher Cooper
Responsible party
Christopher Cooper (Associate Dean, University of Iowa) — Sponsor-investigator
First posted
Mar 7, 2018
Start date
Apr 15, 2018
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Jun 17, 2026

Study contacts

Chris Cooper, MD
principal investigator · MD

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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