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

Christopher Cooper

Status: Enrolling

Conditions: Urinary Bladder, Neurogenic

Treatments: Device: Urodynamics Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04128709

201905843

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must have diagnosed neurogenic bladder

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Neurogenic Bladder Patient

Experimental group

Description:

Patients with neurogenic bladder

Treatment:

Device: Urodynamics Testing