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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04128709
Enrollment
50
Registered
2019-10-16
Start date
2019-11-19
Completion date
2026-12-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Neurogenic

Keywords

urodynamics, neurogenic, bladder

Brief 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.

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.

Interventions

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.

Sponsors

Christopher Cooper
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* must have diagnosed neurogenic bladder

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Home use of bladder pressure monitoring deviceTwo weeksUtilization study of novel external device

Countries

United States

Contacts

Primary ContactChristopher S Cooper, MD
christopher-cooper@uiowa.edu319-384-8922
Backup ContactDenise Juhr, BS
denise-juhr@uiowa.edu319-356-1111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026