Clinical Trials Logo
  1. Home
  2. Urinary Bladder, Neurogenic
  3. NCT03456089
  4. Details
NCT03456089 Clinical Trial

Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

Urinary Bladder, Neurogenic Clinical Trial

Official title:
Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03456089
Other study ID # 201702822
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date June 30, 2024

Study information
Verified date September 2023
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 hooks to the end of a standard urinary catheter. The investigators will be investigating if this device can achieve similar pressure measurements as UDS. The investigators hope is that this device will provide similar measurements to UDS, and can be developed as a home bladder-pressure monitoring tool. This study will enroll children with neurogenic bladder who are currently undergoing UDS as part of their regular care. The measurements will be taken as part of the standard UDS protocol (with insertion of the UDS catheter) and will then be compared to the values obtained with UDS testing.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 99 Years
Eligibility Inclusion Criteria: - must have diagnosed neurogenic bladder - undergoing urodynamics testing as part of routine clinical care Exclusion Criteria: -None

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Urodynamics Testing
Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance

Locations
Country Name City State
United States University of Iowa Hospitals and Clinics, Department of Urology Iowa City Iowa

Sponsors (1)
Lead Sponsor Collaborator
Christopher Cooper

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bladder Pressure Pressure of the bladder at bladder capacity During UDS testing
See also
  Status Clinical Trial Phase
Recruiting NCT05141487 - Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
Completed NCT01920243 - Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (SCI) N/A
Completed NCT04528784 - Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis N/A
Enrolling by invitation NCT03336424 - Urinary Disorders in Patients With Multiple Sclerosis: Invasive Vs Non-invasive Investigations. N/A
Not yet recruiting NCT05075642 - Multicenter Observational Study for the Evaluation in Clinical Practice of Urinary Disorders in Multiple Sclerosis
Completed NCT02600715 - Reduction of Bladder Injection Pain With Belladonna Opiate Suppository Phase 4
Recruiting NCT04128709 - Measurement of Bladder Pressure With a Novel External Device (Cystomanometer) - Home Use N/A
Enrolling by invitation NCT05740527 - Ambulatory Closed-loop Stimulation for Bladder Control N/A
Completed NCT02501928 - Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity. Phase 3
Recruiting NCT06336304 - NXT Post-Market Clinical Follow-up
Completed NCT06445426 - Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
Recruiting NCT04819360 - Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple Sclerosis Phase 4
Terminated NCT02044510 - Urodynamic and Clinical Efficacy of Mirabegron for Neurogenic Bladder Patients Phase 2/Phase 3
Completed NCT01557244 - A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition Phase 3
Recruiting NCT05380661 - Heart Rate Variability and Anxiety During Urinary Bladder Catheterization N/A
Recruiting NCT04193709 - Recovery of Bladder and Sexual Function After Human Spinal Cord Injury N/A
Completed NCT02582151 - Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder N/A
Active, not recruiting NCT05232253 - Cystoealstometer (Bladder Monitor Device)-Home Use N/A
Completed NCT03405285 - Connected Catheter Clinical Feasibility Study( CFS) N/A
Completed NCT02673047 - Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder N/A