Ambulatory Closed-loop Stimulation for Bladder Control

Completed · Not applicable

Conditions studied: Urinary Bladder, Neurogenic

In brief

Individuals with spinal cord injury (SCI) develop neurogenic detrusor overactivity (NDO), resulting in urinary incontinence, decreased bladder capacity, and reduced quality of life. Current treatments incompletely address the problem and have unwanted side effects. Therefore, an alternative approach is needed. Electrical stimulation of the genital nerves (GNS) can inhibit NDO, improving bladder capacity and urinary continence. However, an automated closed-loop bladder feedback system, which currently does not exist, is necessary for individuals with SCI and NDO to utilize this therapy. The researchers have developed a custom algorithm to detect bladder contractions in real time, which requires only a bladder pressure signal. Our collaborators have developed a wireless, catheter-free bladder pressure sensor, called the UroMonitor, that was recently approved for testing in human participants. The goal of this project is to evaluate the potential feasibility and effectiveness of automated closed-loop GNS to inhibit unwanted bladder contractions using our custom algorithm and the wireless UroMonitor sensor. This project represents the next logical step toward improving or restoring bladder control using existing or emerging approaches to meet an important need for individuals with SCI. Successful completion of this project will motivate advancing a closed-loop approach using our custom algorithm and wireless bladder pressure sensor.

Key facts

Study ID

NCT05740527

Run by

MetroHealth Medical Center

People needed

7

Starts

2021-03-01

Expected to finish

2024-10-01

Last updated by the study team

2024-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Suprasacral SCI (above L5/S1 level of the spinal cord)
• Neurologically stable
• Mature skeleton
• At least 6 months post-injury
• Neurogenic detrusor overactity (NDO) confirmed by urodynamic study

You may not qualify if…

• Active sepsis
• Open pressure ulcers on or around the pelvis (electrode sites)
• Significant trauma, erosion, or stricture of the urethra
• History of autonomic dysreflexia

Where it is running

• Metrohealth Medical System — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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