# Innovative Neurogenic Bladder Management for Females and Those with Poor Upper Extremity Motor Function Who Cannot Volitionally Void

> **NIH NIH R43** · CRM MEDICAL DEVICES, INC. · 2020 · $271,127

## Abstract

Specific Aims: “Neurogenic Bladder Management Solution to Promote Independence and Reduce Long
Term Morbidity for Patients Unable to Perform Intermittent Catheterization"
The objective of this proposed SBIR Phase I project is to complete the prototyping, design refinement, and
engineering validation of the EZ-SP device, a novel solution for those unable to perform clean intermittent
catheterization (CIC), the act of passing a catheter through the urethra into the bladder multiple times a day.
CIC is generally employed when a patient is unable to volitionally void as a result of neurologic injury or
disease (most commonly spinal cord injury, multiple sclerosis or spina bifida). The EZ-SP is specifically
intended to aid those with poor upper extremity (UE) motor function, who lack the dexterity to perform CIC, and
females, who have difficulty accessing the urethra (groups that comprise more than 200,000 of the 370,000
patients in the Unites States with neurogenic bladder dysfunction). Our device is intended to increase bladder
specific quality of life, increase urologic convenience and replace alternative bladder management strategies
(leakage into diapers, foley/suprapubic catheters, and reconstructive catheterizable stoma creation) which
result in increased patient morbidity when compared to CIC. The EZ-SP device provides an option for those
who cannot perform independent CIC by:
 Enabling use in persons with poor UE motor function and those that have difficulty accessing their
 urethra by way of an easily accessible drainage port just below the umbilicus
 Providing a simple “magnetic click connector” that requires minimal UE motor function in order to
 facilitate attachment to a urinary drainage device
 Improving cosmesis (low profile with no urinary drainage bag attached to the patient)
 Minimizing maintenance by requiring device changes only once per month in an outpatient setting
 Offering safe device placement with a simple 15-minute outpatient procedure
 Providing a "one-size-fits-all" construct to facilitate adoption by hospital and practitioners
 Significantly minimizing device encrustation compared to other indwelling tubes via active drainage of
 urine from the bladder rather than passive drainage (hence bladder debris will be actively removed)
The target deliverable of Phase 1 will be a complete bench-tested commercial prototype of the
EZ-SP system (tube and drainage system) that is suitable for subsequent clinical testing in Phase 2. To
achieve this objective, this proposed Phase 1 project seeks to confirm the feasibility of the proposed
technological approach by fulfilling the following specific aims
 Specific Aim 1: Optimization of the Dual-Lumen Catheter and its Anchoring Mechanism
 Specific Aim 2: Optimization of the Fixation Wafer
 Specific Aim 3: Optimization of the Click-Connector Drainage System with Human Factors
Assessment
For each of Aims 1-3, the supporting milestones (sub-aims) will be structured as follows:
Mil...

## Key facts

- **NIH application ID:** 10138749
- **Project number:** 1R43DK127580-01
- **Recipient organization:** CRM MEDICAL DEVICES, INC.
- **Principal Investigator:** Christopher Elliott
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $271,127
- **Award type:** 1
- **Project period:** 2020-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10138749

## Citation

> US National Institutes of Health, RePORTER application 10138749, Innovative Neurogenic Bladder Management for Females and Those with Poor Upper Extremity Motor Function Who Cannot Volitionally Void (1R43DK127580-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10138749. Licensed CC0.

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