Spinal Cord InjuriesNCT03877432
Non-invasive Nerve Stimulation for Inhibition of Bladder Incontinence in Spinal Cord Injured Subjects.
A study testing Dermatome stimulation in people with Spinal Cord Injuries, run by Taipei Medical University.
Trial summary
Investigators will test S2-S4 dermatome stimulation with spinal cord injury (SCI) individuals using intermittent catheterization to estimate the clinical impact on bladder capacity and continence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Dermatome stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2016to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Neurologically stable
- Skeletally mature, over 18 years of age.
- At least six (6) months post SCI
- Able to understand and comply with study requirements
- Able to understand and give informed consent.
Who cannot join
- Active sepsis
- Open wound or pressure sores on cutaneous area
- Significant trauma, erosion or stricture of the urethra
- Pregnancy
- Individuals who can not speak.
About this study
Investigators will test S2-S4 dermatome stimulation with spinal cord injury (SCI) individuals using intermittent catheterization to estimate the clinical impact on bladder capacity and continence. For individuals with SCI using intermittent catheterization, investigators hypothesize that dermatome stimulation will decrease bladder spasm frequency and intensity, and reduce bladder incontinence chronically. The goal of this study is to provide objective evidence for the assertion that dermatome stimulation chronically decreases bladder activity and therefore the unwanted side effects of neurogenic bladder. This project will improve the understanding of the neurophysiology of afferent-mediated neural pathways that affect bladder function, and translate recent advances discovered in animal and human studies into clinical research and treatment. The ability to void safely and effectively by electrical stimulation without cutting sacral nerves or the external urethral sphincter would be a major advance. A socially acceptable, predictable and reliable device for reducing incontinence would be widely used and improve quality of life.
Read the detailed description
Investigators will test S2-S4 dermatome stimulation with SCI individuals using intermittent catheterization to estimate the clinical impact on bladder capacity and continence.
For individuals with SCI using intermittent catheterization, investigators will verify that S2-S4 dermatome stimulation is acutely effective at reducing hyper-reflexive bladder activity during bladder filling. Investigators hypothesize that S2-S4 dermatome stimulation will reduce the number and severity of incontinent episodes, increase bladder capacity, and increase the volume catheterized. By comparing the extended outcomes to the acute laboratory outcomes obtained by ourselves and others, investigators can assess the feasibility of acute urodynamics to identify subjects for implanted devices or future studies.
For individuals with SCI using intermittent catheterization, investigators hypothesize that dermatome stimulation will decrease bladder spasm frequency and intensity, and reduce bladder incontinence chronically. The goal of this study is to provide objective evidence for the assertion that dermatome stimulation decreases bladder activity and therefore the unwanted side effects of neurogenic bladder. These experiments will demonstrate the neurophysiologic response of acute stimulation through urodynamic test, and will also provide increased evidence for future clinical trials through proof of lessened bladder pressures - an important cause of vesico-ureteral reflux and renal injury.
There is a potentially larger population of persons with incomplete SCI than complete SCI who retain sensation in the pelvis who could gain benefit from dermatome stimulation. To examine the outcomes following incomplete SCI (in persons who retain sensation in the pelvis), investigators will test dermatome stimulation to determine the tolerable and effective electrical stimulation parameters in persons that have some degree of preserved motor or sensory function through the lowest sacral spinal cord segments. Investigators will acutely measure the effects of dermatome stimulation on bladder pressure and hyper-reflexic bladder contractions during bladder filling. Investigators hypothesize that dermatome stimulation will increase bladder capacity at stimulus amplitudes that are acutely tolerable to subjects with incomplete SCI. It will determine the feasibility of a non-invasive screening procedure to identify potential candidates for future device implantation, thereby providing a pathway for translation of the technology to implantation.
This project will improve the understanding of the neurophysiology of afferent-mediated neural pathways that affect bladder function, and translate recent advances discovered in animal and human studies into clinical research and treatment. The ability to void safely and effectively by electrical stimulation without cutting sacral nerves or the external urethral sphincter would be a major advance. A socially acceptable, predictable and reliable device for reducing incontinence would be widely used and improve quality of life.
- Conditions
- Spinal Cord Injuries
- Being tested
- Dermatome stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermatome stimulationDevice
Dermatome (S2-S4) stimulation is aimed at improving the function of bladder storage and bladder capacity. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. The minimum (or threshold) stimulation amplitude (T) necessary to elicit the genito-anal reflex was first determined for each subject. Subsequently, each subject received a randomized sequence of cystometric fill trials with and without continuous dermatome stimulation. The dermatome stimulation was randomly stimulated at stimulation amplitudes of 1, 2, 3, and 4 T.
| Study group | Role | What they receive |
|---|---|---|
| Dermatome stimulation | Experimental | Check the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation. Receives: Device: Dermatome stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Changes of Bladder Capacity (mL) by Using Urodynamic Measurement
Investigator will verify that S2-S4 dermatome nerve stimulation is acutely effective at reducing hyper-reflexic bladder activity during bladder filling in urodynamic measurement. All experimental trials will be completed in one day for each subject.
Serial cystometrograms will be conducted by filling the bladder with saline and recording the volume in the bladder with or without concomitant nerve stimulation.
A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. Stimulation threshold will be randomly given (1-4 folds of stimulation threshold).
Data from each of 4 stimulation fills per threshold or a total of 4 control fills were averaged. The averaged values are presented per Arm/Group below.
The interval between every fill is 20-40 min. Investigator will compare the difference of bladder capacity (mL) between giving-control fill and fill with stimulation through statistical analysis.
Measured: The outcome measure will be assessed in day 1.
Secondary outcomes (1)
The Changes of Bladder Pressure (cmH2O) During Urodynamic Measurement
Investigator will verify that S2-S4 dermatome nerve stimulation is acutely effective at reducing hyper-reflexic bladder activity during bladder filling in urodynamic measurement. All experimental trials will be completed in one day for each subject. Serial cystometrograms will be conducted by filling the bladder with saline and recording the pressure in the bladder with or without concomitant nerve stimulation. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. Stimulation threshold will be randomly given (1-4 folds of stimulation threshold). The interval between every fill is 20-40 min. Investigator will compare the difference of bladder capacity (mL) between giving-control fill and fill with stimulation through statistical analysis.
Measured: The outcome measure will be assessed in day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start21 Oct 2016
- Primary completion2 Dec 2016
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Wei Peng, Ph.D., Principal investigator, Professor, School of Biomedical Engineering, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877432
- Sponsor's protocol ID
- N201605025
- Status last verified
- Oct 2020
- First submitted
- 4 Mar 2019
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Nerve Stimulation for Inhibition of Bladder Incontinence in Spinal Cord Injured Subjects.
- ClinicalTrials.gov ID
- NCT03877432
- Acronym / sponsor ID
- N201605025
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will test S2-S4 dermatome stimulation with spinal cord injury (SCI) individuals using intermittent catheterization to estimate the clinical impact on bladder capacity and continence. For individuals with SCI using intermittent catheterization, investigators hypothesize that dermatome stimulation will decrease bladder spasm frequency and intensity, and reduce bladder incontinence chronically. The goal of this study is to provide objective evidence for the assertion that dermatome stimulation chronically decreases bladder activity and therefore the unwanted side effects of neurogenic bladder. This project will improve the understanding of the neurophysiology of afferent-mediated neural pathways that affect bladder function, and translate recent advances discovered in animal and human studies into clinical research and treatment. The ability to void safely and effectively by electrical stimulation without cutting sacral nerves or the external urethral sphincter would be a major advance. A socially acceptable, predictable and reliable device for reducing incontinence would be widely used and improve quality of life.
Detailed description
Investigators will test S2-S4 dermatome stimulation with SCI individuals using intermittent catheterization to estimate the clinical impact on bladder capacity and continence.
For individuals with SCI using intermittent catheterization, investigators will verify that S2-S4 dermatome stimulation is acutely effective at reducing hyper-reflexive bladder activity during bladder filling. Investigators hypothesize that S2-S4 dermatome stimulation will reduce the number and severity of incontinent episodes, increase bladder capacity, and increase the volume catheterized. By comparing the extended outcomes to the acute laboratory outcomes obtained by ourselves and others, investigators can assess the feasibility of acute urodynamics to identify subjects for implanted devices or future studies.
For individuals with SCI using intermittent catheterization, investigators hypothesize that dermatome stimulation will decrease bladder spasm frequency and intensity, and reduce bladder incontinence chronically. The goal of this study is to provide objective evidence for the assertion that dermatome stimulation decreases bladder activity and therefore the unwanted side effects of neurogenic bladder. These experiments will demonstrate the neurophysiologic response of acute stimulation through urodynamic test, and will also provide increased evidence for future clinical trials through proof of lessened bladder pressures - an important cause of vesico-ureteral reflux and renal injury.
There is a potentially larger population of persons with incomplete SCI than complete SCI who retain sensation in the pelvis who could gain benefit from dermatome stimulation. To examine the outcomes following incomplete SCI (in persons who retain sensation in the pelvis), investigators will test dermatome stimulation to determine the tolerable and effective electrical stimulation parameters in persons that have some degree of preserved motor or sensory function through the lowest sacral spinal cord segments. Investigators will acutely measure the effects of dermatome stimulation on bladder pressure and hyper-reflexic bladder contractions during bladder filling. Investigators hypothesize that dermatome stimulation will increase bladder capacity at stimulus amplitudes that are acutely tolerable to subjects with incomplete SCI. It will determine the feasibility of a non-invasive screening procedure to identify potential candidates for future device implantation, thereby providing a pathway for translation of the technology to implantation.
This project will improve the understanding of the neurophysiology of afferent-mediated neural pathways that affect bladder function, and translate recent advances discovered in animal and human studies into clinical research and treatment. The ability to void safely and effectively by electrical stimulation without cutting sacral nerves or the external urethral sphincter would be a major advance. A socially acceptable, predictable and reliable device for reducing incontinence would be widely used and improve quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermatome stimulation | Experimental | Device: Dermatome stimulationCheck the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Suprasacral SCI
- Neurologically stable
- Skeletally mature, over 18 years of age.
- At least six (6) months post SCI
- Able to understand and comply with study requirements
Key exclusion criteria (5 listed)
- Active sepsis
- Open wound or pressure sores on cutaneous area
- Significant trauma, erosion or stricture of the urethra
- Pregnancy
- Individuals who can not speak.
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 |
|---|---|---|
| Dermatome stimulationDermatome (S2-S4) stimulation is aimed at improving the function of bladder storage and bladder capacity. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. The minimum (or threshold) stimulation amplitude (T) necessary to elicit the genito-anal reflex was first determined for each subject. Subsequently, each subject received a randomized sequence of cystometric fill trials with and without continuous dermatome stimulation. The dermatome stimulation was randomly stimulated at stimulation amplitudes of 1, 2, 3, and 4 T. | Device | Dermatome stimulation |
Primary outcome
The Changes of Bladder Capacity (mL) by Using Urodynamic Measurement
Time frame: The outcome measure will be assessed in day 1.
Investigator will verify that S2-S4 dermatome nerve stimulation is acutely effective at reducing hyper-reflexic bladder activity during bladder filling in urodynamic measurement. All experimental trials will be completed in one day for each subject. Serial cystometrograms will be conducted by filling the bladder with saline and recording the volume in the bladder with or without concomitant nerve stimulation. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. Stimulation threshold will be randomly given (1-4 folds of stimulation threshold). Data from each of 4 stimulation fills per threshold or a total of 4 control fills were averaged. The averaged values are presented per Arm/Group below. The interval between every fill is 20-40 min. Investigator will compare the difference of bladder capacity (mL) between giving-control fill and fill with stimulation through statistical analysis.
1 secondary outcome
The Changes of Bladder Pressure (cmH2O) During Urodynamic Measurement
Time frame: The outcome measure will be assessed in day 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Chih-Wei Peng, Ph.D. principal investigator
Professor, School of Biomedical Engineering, Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Dermatome stimulation in people with Spinal Cord Injuries, run by Taipei Medical University.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Changes of Bladder Capacity (mL) by Using Urodynamic Measurement (time frame: The outcome measure will be assessed in day 1.). 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 20 Jan 2021.