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

Not Applicable

Recruiting

• Conditions: Urinary Bladder, Neurogenic
• Interventions: Device: Urodynamics Testing

• Registration Number: NCT04128709
• Lead Sponsor: Christopher Cooper

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.

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2019-11-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• must have diagnosed neurogenic bladder

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurogenic Bladder Patient	Urodynamics Testing	Patients with neurogenic bladder

Primary Outcome Measures

Name	Time	Method
Home use of bladder pressure monitoring device	Two weeks	Utilization study of novel external device

Trial Locations

Locations (1)

University of Iowa Hospital and Clinics; 🇺🇸 Iowa City, Iowa, United States