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Non-invasive Nerve Stimulation for Inhibition of Bladder Incontinence in Spinal Cord Injured Subjects.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03877432
Recruitment Status : Active, not recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University

Brief Summary:
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 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Dermatome stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Nerve Stimulation for Inhibition of Bladder Incontinence in Spinal Cord Injured Subjects.
Actual Study Start Date : June 29, 2016
Actual Primary Completion Date : June 28, 2018
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dermatome stimulation
Check the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation.
Device: Dermatome stimulation
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.




Primary Outcome Measures :
  1. The changes of bladder capacity 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 and 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 between giving-control fill and fill with stimulation through statistical analysis.


Secondary Outcome Measures :
  1. The changes of bladder pressure during 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 and 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 between giving-control fill and fill with stimulation through statistical analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Active sepsis
  • Open wound or pressure sores on cutaneous area
  • Significant trauma, erosion or stricture of the urethra
  • Pregnancy
  • Individuals who can not speak.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877432


Sponsors and Collaborators
Taipei Medical University
Investigators
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Principal Investigator: Chih-Wei Peng, Ph.D. Professor, School of Biomedical Engineering, Taipei Medical University
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Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT03877432    
Other Study ID Numbers: N201605025
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Enuresis
Urinary Incontinence
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations