- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128709
Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher S Cooper, MD
- Phone Number: 319-384-8922
- Email: christopher-cooper@uiowa.edu
Study Contact Backup
- Name: Denise Juhr, BS
- Phone Number: 319-356-1111
- Email: denise-juhr@uiowa.edu
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa Hospital and Clinics
-
Contact:
- Denise Juhr
- Phone Number: 319-356-1111
- Email: denise-juhr@uiowa.edu
-
Principal Investigator:
- Christoper S Cooper, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- must have diagnosed neurogenic bladder
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neurogenic Bladder Patient
Patients with neurogenic bladder
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Home use of bladder pressure monitoring device
Time Frame: Two weeks
|
Utilization study of novel external device
|
Two weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher S Cooper, MD, University of Iowa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201905843
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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