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Cystoealstometer (Bladder Monitor Device)-Home Use

Primary Purpose

Urinary Bladder, Neurogenic

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cystoelastometer - Urodynamics Testing
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Bladder, Neurogenic focused on measuring urodynamics, neurogenic, bladder

Eligibility Criteria

6 Months - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients seen in the University of Iowa Pediatric Urology Clinic with neurogenic bladder managed with clean intermittent catheterization.
  • Patients who haven't had any change in management
  • Patients who had recently had UDS (urodynamic study) performed

Exclusion Criteria:

  • phone which is not iOS compatible

Sites / Locations

  • University of Iowa Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurogenic Bladder Patient

Arm Description

Patients with neurogenic bladder

Outcomes

Primary Outcome Measures

Home use of bladder pressure and volume monitoring device- Cystoelastometer
Utilization study of novel external cystoelastometer device - Home bladder pressure and volume monitor recorded in terms of cm H2O pressure and urine evacuation device with volume measurement in terms of milliliters.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2022
Last Updated
February 15, 2023
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT05232253
Brief Title
Cystoealstometer (Bladder Monitor Device)-Home Use
Official Title
Measurement of Bladder Pressure With a Novel External Device (Cystoealstometer) - Home
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators have developed a novel pressure monitoring device called a 'cystoelastometer' that connects to a drainage end ofastandard 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 in measuring bladder pressure compared to the gold standard urodynamics that are performed in the clinic or hospital. This study will assess the patients and care givers ability and experience using the cystoelastometer 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 and bladder volume monitoring device which is portable and attaches to the end of a standard urinary catheter and measures the pressure in the device and then assists in the drainage of the bladder and records the bladder volume. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Neurogenic
Keywords
urodynamics, neurogenic, bladder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurogenic Bladder Patient
Arm Type
Experimental
Arm Description
Patients with neurogenic bladder
Intervention Type
Device
Intervention Name(s)
Cystoelastometer - Urodynamics Testing
Intervention Description
The non-invasive cystoelastometer device connects to the drainage end of urinary catheter that the patient uses for routine daily catheterization. Once urine flows into the device a pressure measurement is recorded and stored in the device along with the time and date. The remaining urine is then evacuated through the catheter and device and the cystoelastometer records the volume of urine evacuated. The measurement(s) of bladder pressure and volume as well as the time and date can later be transmitted wirelessly to a smart phone that contains an app for the device.
Primary Outcome Measure Information:
Title
Home use of bladder pressure and volume monitoring device- Cystoelastometer
Description
Utilization study of novel external cystoelastometer device - Home bladder pressure and volume monitor recorded in terms of cm H2O pressure and urine evacuation device with volume measurement in terms of milliliters.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients seen in the University of Iowa Pediatric Urology Clinic with neurogenic bladder managed with clean intermittent catheterization. Patients who haven't had any change in management Patients who had recently had UDS (urodynamic study) performed Exclusion Criteria: phone which is not iOS compatible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher S Cooper, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cystoealstometer (Bladder Monitor Device)-Home Use

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