Ambulatory Closed-loop Stimulation for Bladder Control

NCT05740527 | Completed FDA Device

• 1 other identifier: 19-00690
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Bladder, Neurogenic

Keywords

spinal cord injury; bladder; urinary incontinence; stimulation; closed loop; reducing bladder spasms

Outcome Measures

Primary Outcomes (1)

• successful reduction of neurogenic bladder spasms

  The closed-loop system has been designed to detect neurogenic bladder spasms (contractions) and to turn on a device to deliver genital nerve stimulation. Genital nerve stimulation has been shown previously to relax NDO bladder spasms and therefore allow for increased capacity, longer time between catheterization, and a reduction in incontinence episodes. The outcome for this feasibility trial will be the ability of the system to perform within expected parameters (\<5% false negative, \<10% false positive, \<5 s response time) to control NDO bladder contractions.

  within 2 weeks of completing the screening visit

Secondary Outcomes (2)

• Documentation of NDO with cystometrogram (urodynamics)

  within 1 week of signing consent form

• Comparison of bladder activity with and without genital nerve stimulation

  within 1 week of signing consent form

Study Arms (1)

Testing closed-loop system in an ambulatory setting

OTHER

Closed-loop system feasibility testing

Device: Noninvasive electrical stimulation of genital nerves

Interventions

Noninvasive electrical stimulation of genital nerves DEVICE

A closed-loop system (in-bladder sensor, radio, algorithm, and stimulator) is being tested for the feasibility of inhibiting neurogenic bladder overactivity in an ambulatory setting.

Testing closed-loop system in an ambulatory setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Metrohealth Medical System

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Cord Injuries; Urinary Incontinence

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; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Dennis Bourbeau, PhD

  MetroHealth Rehabilitation Institute of Ohio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 23, 2023
• Study Start: March 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)