Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05740527 |
Other study ID # |
19-00690 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2021 |
Est. completion date |
July 31, 2024 |
Study information
Verified date |
June 2024 |
Source |
MetroHealth Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
This study has three study visits: a consenting visit (~1 hour), a screening visit (~4
hours), and an ambulatory visit (~8 hours).
Visit 1: The participant will have the study explained to their satisfaction and sign the
consent form, if the participant chooses to participate. A urine sample is collected to test
for urinary tract infections and a prophylactic antibiotic is prescribed.
Note: The participant is asked to refrain from taking medications related to bladder
relaxation (Ditropan, Oxybutynin, Detrol, Tolterodine Tartate, Tofranil, Imipramine, Urimax,
Xanodine, Enablex, Darifenain) as these will interfere with the study. When to stop these
medications will be discussed with the participant at this visit.
Visit 2: The participant will have a urodynamic screening visit to confirm NDO activity,
determine the response to stimulation, and determine the most effective stimulation
parameters for genital nerve stimulation.
- Urodynamics involves a catheter being inserted into the bladder to collect pressure
readings from the bladder, and urethral sphincter, as well as infuse saline (salt water)
into the bladder. This will be done up to 6 times, with and without stimulation, over
the course of the 4 hour screening visit.
- During urodynamics a catheter is also inserted into the rectum. This sensor detects
abdominal pressure during urodynamics and is used to determine the pressure in the
bladder.
Note: There is an optional procedure that can be done in this visit called anorectal
manometry (ARM). The rectal catheter that is inserted during urodynamics can also be used to
investigate bowel function. If interested, the participant would be asked to perform several
actions (cough, push as is if to defecate, or squeeze as if to withhold a bowel movement) and
the response of the anal sphincter and rectum are measured.
Visit 3: If the participant has confirmed NDO, the participant will be invited to a longer
visit (~8 hours) wherein the participant will test the full closed-loop stimulation system.
The person will be asked to stay at the hospital for this visit but are encouraged to move
about the building. This could involve going to the cafeteria or other public spaces. To
accomplish closed-loop control of bladder function it will be necessary to:
- Insert a sensor into the bladder (UroMonitor) through the urethra. This sensor has been
designed to stay inside the bladder and measure pressure without requiring a catheter to
remain in the urethra. Once the study is completed the sensor will be retrieved via a
suture that remains in the urethra.
- Confirm that the sensor is accurately detecting bladder pressure by comparing sensor
values with urodynamics values. This will be done by using a urodynamics catheter and
sensor at the same time for a short time.
- Having genital nerve stimulation electrodes affixed to the appropriate areas of the
genitals. For men, these electrodes are put on the top of the penis. For women, these
electrodes are placed on the labia majora near the clitoris. A ground electrode will be
put on the inner thigh for both men and women. These electrodes will be connected to a
transcutaneous electrical nerve stimulation (TENS) unit calibrated to deliver the
appropriate current parameters for that participant (determined in visit 2).
- Donning the closed-loop system. The closed-loop system detects the sensor data, uses an
algorithm to determine if stimulation should be applied, and then turns on the
stimulation unit.
Once the participant is instrumented, the participant will be able to move about the building
without restriction. This could include going to the cafeteria and moving through the
hallways, rather than being sedentary in a procedure room. A study member will accompany the
participant as the participant ambulates throughout the building and uses a computer tablet
to view the bladder data.
Depending on how long it takes for the bladder to naturally fill, it may be possible to
collect data from two fill-void cycles (~3 hours each). After data collection, the
participant will be taken back to the procedure room and the instrumentation will be removed.
That includes removal of the bladder sensor by the urologist on the study.
Participants will be asked for feedback which will include: what the participant experiences
during the study, the design of the system, function of the system, any bladder related
sensations, if the participant feels that the system would benefit quality of life, and if
the participant would be likely to use the system.