Recruiting

Cystomanometer

Sponsor:

Christopher Cooper

Code:

NCT04128709

Conditions

Urinary Bladder, Neurogenic

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

Interventions

Urodynamics Testing

Study Details

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

Study ID

NCT04128709

Start date

Nov 19, 2019

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • must have diagnosed neurogenic bladder

Exclusion Criteria:

  • None

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Neurogenic Bladder Patient

Patients with neurogenic bladder

Interventions

Urodynamics Testing

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

  • Home use of bladder pressure monitoring device [ Time Frame: Two weeks ]

Central Contacts and Locations

Central contacts

Christopher S Cooper, MD

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

Denise Juhr, BS

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

Locations

University of Iowa Hospital and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Denise Juhr

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

Principal Investigator:

Christoper S Cooper, MD

More Information

Sponsor

Christopher Cooper

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • urodynamics
  • neurogenic
  • bladder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Christopher Cooper on 2025-12-22.