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

NCT03877432 | Unknown Results

• 1 other identifier: N201605025
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  The outcome measure will be assessed in day 1.

Secondary Outcomes (1)

• The Changes of Bladder Pressure (cmH2O) During Urodynamic Measurement

  The outcome measure will be assessed in day 1.

Study Arms (1)

Dermatome stimulation

EXPERIMENTAL

Check the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation.

Device: Dermatome stimulation

Interventions

Dermatome stimulation DEVICE

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.

Dermatome stimulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Chih-Wei Peng
• Organization: Taipei Medical University

cwpeng@tmu.edu.tw

886-2-27361661

Study Officials

• Chih-Wei Peng, Ph.D.

  Professor, School of Biomedical Engineering, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 15, 2019
• Study Start: October 21, 2016
• Primary Completion: December 2, 2016
• Study Completion: August 1, 2021
• Last Updated: January 20, 2021
• Results First Posted: January 20, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share