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

NCT04128709 | Recruiting FDA Device

• 1 other identifier: 201905843
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder, Neurogenic

Keywords

urodynamics; neurogenic; bladder

Outcome Measures

Primary Outcomes (1)

• Home use of bladder pressure monitoring device

  Utilization study of novel external device

  Two weeks

Study Arms (1)

Neurogenic Bladder Patient

EXPERIMENTAL

Patients with neurogenic bladder

Device: Urodynamics Testing

Interventions

Urodynamics Testing DEVICE

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.

Neurogenic Bladder Patient

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• must have diagnosed neurogenic bladder

You may not qualify if:

• None

Sponsors & Collaborators

• Christopher Cooper: lead

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher S Cooper, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher S Cooper, MD

CONTACT

319-384-8922; christopher-cooper@uiowa.edu

Denise Juhr, BS

CONTACT

319-356-1111; denise-juhr@uiowa.edu

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: October 14, 2019
• First Posted: October 16, 2019
• Study Start: November 19, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)