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NCT Number: NCT04128709

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

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.

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Key information

Conditions

Urinary Bladder, Neurogenic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

1 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Christoper S Cooper, MD

PRINCIPAL_INVESTIGATOR

Denise Juhr

CONTACT

[email protected]

319-356-1111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • must have diagnosed neurogenic bladder

Exclusion criteria

  • None

Treatment and study plan

Urodynamics Testing

Device

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.

Primary outcomes

  1. Home use of bladder pressure monitoring device

    Time frame: Two weeks

    Utilization study of novel external device

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher S Cooper, MD

CONTACT

[email protected]

319-384-8922

Denise Juhr, BS

CONTACT

[email protected]

319-356-1111

Sponsors and collaborators

Lead sponsor

Christopher Cooper

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2019
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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