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

Primary Purpose

Urinary Bladder, Neurogenic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urodynamics Testing
Sponsored by
Christopher Cooper
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

1 Year - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • must have diagnosed neurogenic bladder

Exclusion Criteria:

  • None

Sites / Locations

  • University of Iowa Hospital and ClinicsRecruiting

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 monitoring device
Utilization study of novel external device

Secondary Outcome Measures

Full Information

First Posted
October 14, 2019
Last Updated
September 12, 2023
Sponsor
Christopher Cooper
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1. Study Identification

Unique Protocol Identification Number
NCT04128709
Brief Title
Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use
Official Title
Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Cooper

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.
Yes
Data Monitoring Committee
No

5. Study Description

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.

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
50 (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)
Urodynamics Testing
Intervention Description
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 Outcome Measure Information:
Title
Home use of bladder pressure monitoring device
Description
Utilization study of novel external device
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must have diagnosed neurogenic bladder Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher S Cooper, MD
Phone
319-384-8922
Email
christopher-cooper@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Juhr, BS
Phone
319-356-1111
Email
denise-juhr@uiowa.edu
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Juhr
Phone
319-356-1111
Email
denise-juhr@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Christoper S Cooper, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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