Urinary Bladder, NeurogenicNCT05740527
Ambulatory Closed-loop Stimulation for Bladder Control
A study testing Noninvasive electrical stimulation of genital nerves in people with Urinary Bladder, Neurogenic, run by MetroHealth Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Neurogenic
- What is being tested?
- Noninvasive electrical stimulation of genital nerves
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active sepsis
- Open pressure ulcers on or around the pelvis (electrode sites)
- Significant trauma, erosion, or stricture of the urethra
- History of autonomic dysreflexia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambulatory Closed-loop Stimulation to Inhibit Neurogenic Bladder Over-activity
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.
Read the detailed 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.
- Conditions
- Urinary Bladder, Neurogenic
- Being tested
- Noninvasive electrical stimulation of genital nerves
- Keywords
- spinal cord injury, bladder, urinary incontinence, stimulation, closed loop, reducing bladder spasms
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Cord Injuries, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive electrical stimulation of genital nervesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Testing closed-loop system in an ambulatory setting | Other | Closed-loop system feasibility testing Receives: Device: Noninvasive electrical stimulation of genital nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 2 weeks of completing the screening visit
Secondary outcomes (2)
Documentation of NDO with cystometrogram (urodynamics)
To confirm the presence of NDO a cystometrogram will be conducted. This procedure uses a triple-lumen catheter inserted into the bladder which is used to fill the bladder with saline, measure bladder pressure, and measure urethral pressure. As the bladder is filled with saline the pressure readings will show if there are NDO contractions (sharp increase in bladder pressure AND an increase in sphincter pressure). This confirmation is necessary for eligibility in the study and can be informative for the participant.
Measured: within 1 week of signing consent form
Comparison of bladder activity with and without genital nerve stimulation
During the screening visit (visit 2) the participant will undergo urodynamics testing to verify NDO. After verification of NDO, the procedure will be repeated with either effective or sham stimulation (up to 6 times total). This is to calibrate the stimulation parameters (amplitude) to ensure effective stimulation as well as to collect data regarding changes in bladder function due to genital nerve stimulation.
Measured: within 1 week of signing consent form
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Mar 2021
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, NeurogenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Dennis Bourbeau, MetroHealth Medical Center
- Investigators
- Dennis Bourbeau, PhD, Principal investigator, MetroHealth Rehabilitation Institute of Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740527
- Sponsor's protocol ID
- 19-00690
- Status last verified
- Oct 2024
- First submitted
- 1 Feb 2023
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no intention of sharing individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Closed-loop Stimulation to Inhibit Neurogenic Bladder Over-activity
- ClinicalTrials.gov ID
- NCT05740527
- Acronym / sponsor ID
- 19-00690
- Conditions
- Urinary Bladder, Neurogenic
- Keywords
- spinal cord injury, bladder, urinary incontinence, stimulation, closed loop, reducing bladder spasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testing closed-loop system in an ambulatory setting | Other | Device: Noninvasive electrical stimulation of genital nervesClosed-loop system feasibility testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Active sepsis
- Open pressure ulcers on or around the pelvis (electrode sites)
- Significant trauma, erosion, or stricture of the urethra
- History of autonomic dysreflexia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive electrical stimulation of genital nervesA 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. | Device | Testing closed-loop system in an ambulatory setting |
Primary outcome
successful reduction of neurogenic bladder spasms
Time frame: within 2 weeks of completing the screening visit
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.
2 secondary outcomes
Documentation of NDO with cystometrogram (urodynamics)
Time frame: within 1 week of signing consent form
Comparison of bladder activity with and without genital nerve stimulation
Time frame: within 1 week of signing consent form
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No. There is no intention of sharing individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Bourbeau, PhD principal investigator
MetroHealth Rehabilitation Institute of Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive electrical stimulation of genital nerves in people with Urinary Bladder, Neurogenic, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful reduction of neurogenic bladder spasms (time frame: within 2 weeks of completing the screening visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.