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RecruitingNCT04128709Updated Dec 22, 2025

Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use

An interventional study of Urodynamics Testing in Urinary Bladder, Neurogenic, sponsored by Christopher Cooper. Recruiting at 1 site in United States. Open to participants aged 1 Year to 99 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

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

From the registry’s dates

  • Started Nov 2019; still recruiting 6 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
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 that are used by patients with a neurogenic bladder on daily clean intermittent catheterization. The device has already been demonstrated to be accurate compared to the gold standard in clinic urodynamics. This study will assess the patients and care givers ability and experience using the device in a home setting.

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 attaches to the end of a standard urinary catheter. The investigators will be investigating if this device can be used by patients or their caregivers in a home setting.

This study will enroll patients with neurogenic bladder that currently perform clean intermittent catheterization on a daily basis as part of their regular care. The patients will be asked to use the device at least twice a day for two weeks.

02

Conditions studied

  • Urinary Bladder, Neurogenic

Keywords

  • urodynamics
  • neurogenic
  • bladder
03

In context

Urinary Bladder, Neurogenic

189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.

This study's planned enrollment of 50 is above the median of 39 across 125 interventional studies indexed under Urinary Bladder, Neurogenic.

Browse Urinary Bladder, Neurogenic studies →

Lead sponsor

Christopher Cooper is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • must have diagnosed neurogenic bladder

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

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

Study arms

  • Experimental
    Neurogenic Bladder Patient

    Patients with neurogenic bladder

    Device: Urodynamics Testing

Interventions

  • DeviceUrodynamics Testing

    The non-invasive device connects to the end of urinary catheter that the patient uses for routine daily catheterization. Once urine flows into the device the patient presses a single button in order to obtain a pressure measurement which is recorded and stored in the device along with the time and date. The measurement(s) can later be transmitted wirelessly to a smart phone that contains an app for the device.

06

What researchers measure

Primary outcomes

  1. Home use of bladder pressure monitoring device

    Utilization study of novel external device

    Time frame: Two weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04128709
Lead sponsor
Christopher Cooper
Responsible party
Christopher Cooper (Associate Dean, University of Iowa) — Sponsor-investigator
First posted
Oct 16, 2019
Start date
Nov 19, 2019
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 22, 2025

Study contacts

Christopher S Cooper, MD
Contact
christopher-cooper@uiowa.edu
319-384-8922
Denise Juhr, BS
Contact
denise-juhr@uiowa.edu
319-356-1111
Christopher S Cooper, MD
principal investigator · University of Iowa

Oversight

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

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