NCT03456089

Brief Summary

The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

7.7 years

First QC Date

February 28, 2018

Last Update Submit

December 3, 2024

Conditions

Urinary Bladder, NeurogenicUrodynamics

Keywords

urodynamicsneurogenicbladder

Outcome Measures

Primary Outcomes (1)

  • Bladder Pressure

    Pressure of the bladder at bladder capacity

    During UDS testing

Study Arms (1)

Neurogenic Bladder Patients

OTHER

Patients with neurogenic bladder undergoing urodynamics testing

Diagnostic Test: Urodynamics Testing

Interventions

Urodynamics TestingDIAGNOSTIC_TEST

Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance

Neurogenic Bladder Patients

Eligibility Criteria

Age1 Year - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • must have diagnosed neurogenic bladder
  • undergoing urodynamics testing as part of routine clinical care

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics, Department of Urology

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chris Cooper, MD

    MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Dean

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

April 15, 2018

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)