High Frequency Sacral Root Stimulation to Improve Bladder and Bowel Emptying Following SCI
Phase: EARLY_PHASE1
Conditions: Spinal Cord Injury
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
[1669332] High-frequency sacral root stimulation to improve bladder and bowel emptying following SCI 
 
Funding Agency: Department of Veterans Affairs 
 
Principal Investigator/Study Chair: Dennis Bourbeau, PhD 
 
Version 1.6 
2 February 2023 
 
 

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Abstract 
 
This is a 2-year case series study. Study participants will act as their own controls. This study 
will determine if sacral root stimulation at 600 Hz limits urethral sphincter contractions in 
individuals with SCI who have already been implanted with a Finetech-Brindley SARS system. 
The Finetech-Brindley SARS system is an FDA-approved device (Humanitarian Use Device) 
and we have received an IDE for testing this device at 600 Hz. In an initial visit lasting about 1 
hour, we will complete an informed consent process to enroll the participant and collect a 
urine sample to test for a UTI. In a second visit lasting about 4 hours, we will conduct 
experiment procedures. Bladder and urethral sphincter pressures will be recorded using 
standard clinical urodynamics techniques. In a urodynamics laboratory, we will collect 
baseline data in response to the typical stimulation parameters that the participant uses for 
their daily bladder management. We will then test 600 Hz stimulation to determine whether 
this results in reduced sphincter contraction (Aim 1). The Finetech-Brindley device can also 
be programmed to achieve bowel emptying and return of bowel control is an extremely high 
priority for individuals with SCI [7]. Therefore, we will leverage the opportunity of this pilot 
study to determine if 600 Hz sacral root stimulation also has the potential to improve bowel 
emptying by reducing anal sphincter pressure (Aim 2). Participants will be asked to participate 
in experiments for both Aim 1 and Aim 2. Study participants who are Veterans will be 
consented and tested at the Cleveland VA Medical Center. Participants who are not Veterans 
will be consented and tested at the MetroHealth Medical Center. An IRB protocol for this 
study has already been approved at the MetroHealth Medical Center. 
 

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List of Abbreviations 
 
CRC – Clinical Research Center 
DSD – detrusor-sphincter dyssynergia 
FES – functional electrical stimulation 
LSCVAMC – Louis Stokes Cleveland Department of Veterans Affairs Medical Center  
NIDDK - National Institute of Diabetes and Digestive and Kidney 
NIH – National Institute of Health 
SARS - sacral anterior root stimulation 
SCI - spinal cord injury 
SCI&D - Spinal Cord Injury & Dysfunction 
TDL - Technical Development Laboratory 
 
 

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Contents 
Protocol Title: .................................................................................................................. 5 
1.0 
Study Personnel .................................................................................................... 5 
2.0 
Introduction ............................................................................................................ 6 
3.0 
Objectives .............................................................................................................. 6 
4.0 
Resources and Personnel ..................................................................................... 6 
5.0 
Study Procedures .................................................................................................. 7 
5.1 Study Design .......................................................................................................... 7 
5.2 Recruitment Methods ............................................................................................. 9 
5.3 Informed Consent Procedures ............................................................................... 9 
5.4 Inclusion/Exclusion Criteria .................................................................................... 9 
5.5 Study Evaluations ................................................................................................ 10 
5.6 Data Analysis ....................................................................................................... 12 
5.7 Withdrawal of Subjects......................................................................................... 12 
6.0 Risks.……………..………………………………………………………………………...12 
7.0 
Reporting ............................................................................................................. 13 
8.0 
Privacy and Confidentiality .................................................................................. 13 
9.0 
Communication Plan ........................................................................................... 13 
10.0 References .......................................................................................................... 14 
 
 
 

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Protocol Title:   
 
1.0 
Study Personnel 
 
o Principal Investigators/Study Chairs: 
 
Dennis Bourbeau, PhD 
Biomedical Engineer 
Cleveland VA Medical Research 
dbourbeau@fescenter.org 
access to identifiable VA patient data: Yes 
 
o Co-Investigators: 
 
 
 
Mary Ann Richmond, MD, PhD  
Chief of the Spinal Cord Injury Service 
 
 
 
MaryAnn.Richmond@va.gov 
access to identifiable VA patient data: Yes 
 
Hui Zhu, ScD, MD 
Cleveland VA Medical Research 
Cleveland Clinic Foundation 
zhuh3@ccf.org 
access to identifiable VA patient data: Yes 
 
Kenneth Gustafson, PhD 
Faculty at Case Western Reserve University 
VA Without Compensation (WOC) appointment 
kjg@case.edu 
access to identifiable VA patient data: Yes 
 
o Collaborators: 
 
James Wilson, DO 
MetroHealth Medical Center 
VA Without Compensation (WOC) appointment 
Jwilson4@metrohealth.org 
access to identifiable VA patient data: No 
 
 
 
Robert Hoey, PhD 
MetroHealth Medical Center 
VA IPA 
rhoey@metrohealth.org 
access to identifiable VA patient data: No 
 

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Hailey Chesnick, RN 
MetroHealth Medical Center 
VA IPA 
hchesnick@metrohealth.org 
access to identifiable VA patient data: Yes 
 
Kimberly Schach 
MetroHealth Medical Center 
VA IPA 
kschach@metrohealth.org 
 
access to identifiable VA patient data: Yes 
 
• Number of potential participating sites: 2 
 
2.0 
Introduction 
Spinal cord injury (SCI) leads to neurogenic bladder dysfunctions, and often includes 
difficulty with emptying the bladder due to detrusor-sphincter dyssynergia (DSD). 
Current bladder management strategies include catheterization, pharmaceuticals, 
and/or surgery, but these interventions insufficiently meet individuals’ needs. The 
neurogenic bladder can be emptied using sacral anterior root stimulation (SARS) with 
electrodes implanted on the sacral nerves to produce bladder contractions. However, 
this emptying can be impeded by reflex contractions of the urethral sphincter. The 
sacral sensory roots are typically transected (rhizotomy) to reduce these reflex 
contractions, but this rhizotomy also impairs desirable reflexes (e.g., sexual function) 
and sacral sensation if present. Experiments in animals have shown that sacral root 
stimulation at 600 Hz can inhibit urethral sphincter activity, which has the potential. This 
approach could be used in lieu of the rhizotomy to improve bladder emptying efficiency.  
 
3.0 
Objectives 
The objective of this study is to test the potential effectiveness of 600 Hz sacral root 
stimulation to limit urethral sphincter activity in individuals with neurogenic bladder 
dysfunction (Aim 1). We hypothesize that sacral root stimulation at 600 Hz will result in 
lower urethral sphincter pressures compared to pressures in response to stimulation at 
the lower frequencies that are typically used for SARS. We will also test if this 
stimulation similarly limits anal sphincter activity (Aim 2). Individuals will already have 
received an implanted SARS device and will have also received a rhizotomy. 
 
4.0 
Resources and Personnel 
 
Principal Investigators:  
 
Dennis Bourbeau, PhD  
Affiliate: Cleveland VA Medical Research & MetroHealth Medical Center 
Responsibilities: Responsible for the overall conduct of study activities, including 
identifying interested individuals to participate, obtaining informed consent, data 

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collection and analysis, regulatory oversight, and dissemination of results. Research 
staff will report directly to him. 
 
Co-Investigators:  
Mary Ann Richmond, MD, PhD  
Affiliate: Cleveland VA Medical Research  
Responsibilities: assist with experiment oversight, be responsible for assuring access to 
appropriate facilities, and overseeing adherence to good clinical practice. 
 
Hui Zhu, ScD, MD 
Affiliate: Cleveland VA Medical Research & Cleveland Clinic Foundation 
Responsibilities: Participate in experiment oversight and results interpretation. 
 
Kenneth Gustafson, PhD 
Affiliate: Faculty at Case Western Reserve University / VA Without Compensation 
(WOC) appointment 
Responsibilities: contribute to protocol refinement, interpretation of results, and 
dissemination of findings. 
 
Research Nurse: TBD 
 
Study Coordinator: TBD 
 
5.0 
Study Procedures 
 
5.1 Study Design 
In this 2-year case series study, we will enroll 8 participants, male or female, who 
have SCI and who already use implanted sacral root anterior stimulation to 
manage their bladder. Participants will act as their own controls. 
 
If a participant is a Veteran, then they will complete study visits at the Cleveland 
VA Medical Center. If they are not a Veteran, then they will complete study visits 
at MetroHealth Medical Center for which we already have an approved IRB 
protocol. 
 
During an initial study visit, expected to take about one hour, we will obtain 
informed consent. Then a sample of urine will be collected and tested to 
determine if they have a urinary tract infection. 
 
In the days following this initial visit, subjects will be prescribed an antibiotic, 
which they will pick up from Pharmacy, to take in the days before and after 
participation in this study to prevent a urinary tract infection. We will contact 
subjects in the days leading up to the second visit to remind them of the 
antibiotic. 
 

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A second study visit will then occur 2-30 days later and last about 4 hours. 
Stimulus waveforms for urethral sphincter inhibition will be tested in the clinical 
laboratory in a single session. We will not need to conduct new surgeries or 
implant procedures. The primary outcome measure is urethral sphincter 
pressure, and additional outcome measures include bladder pressure, rectal 
pressure, and bladder volume as measured in clinically standard urodynamics 
examination. The primary outcome measure for Aim 2 is anal sphincter pressure. 
 
Clinical Impact 
This study represents the first attempt to limit urethral sphincter contraction via 
600 Hz stimulation of sacral roots in human participants. This approach using 
600 Hz sacral root stimulation has successfully demonstrated voiding in chronic 
spinalized dogs, but has not been tested in humans. The Finetech-Brindley 
external controller has been modified to be capable of producing stimulation up 
to 600Hz. An Investigational Device Exemption has been obtained from the FDA 
to test this approach in human participants. Thus, one significant advantage of 
our study is that we will use this modified external controller to communicate with 
the already-implanted components of the system without new surgical 
procedures or significant risks. A second key advantage is that, because they 
have had a posterior rhizotomy, we can determine the stimulation parameters for 
activating and potentially limiting sphincter activity directly via the motor nerves, 
without confounding effects from sacral spinal reflexes. If this project is 
successful, these parameters can be applied in a future project to individuals who 
can have a stimulator implanted without rhizotomy, to determine if reflex 
activation of the sphincter can also be reduced. We understand that future work 
without rhizotomy will include the influence of reflex pathways, and this study 
may help us understand that influence by having this negative control. A future 
project would also then refine this approach by combining 600 Hz stimulation to 
reduce sphincter pressure with 20 Hz stimulation to evoke bladder contraction. 
 
This project could have a high impact for individuals with neurogenic bladder 
dysfunction. It would help to address one of the highest priorities of individuals 
with SCI – restoration of bladder function - and help to address some of the 
biggest costs and health risks associated with managing neurogenic bladder by 
potentially improving bladder emptying without the need for catheters. There is a 
high potential for clinical translation because this approach takes advantage of 
existing technologies. 
 
If this project demonstrates evidence of urethral sphincter pressure reduction in 
response to 600 Hz stimulation, then we will propose in a subsequent project to 
apply 600 Hz stimulation to individuals with SCI in whom sacral reflexes are 
intact. We would implant a SARS device without the rhizotomy, and determine if 
reflex contractions of the sphincter can be prevented during bladder emptying. In 
this way, we plan to achieve efficient, catheter-free, on-demand bladder emptying 
using sacral root stimulation without the need for a posterior rhizotomy. 
 

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5.2 Recruitment Methods 
Eight participants will be enrolled, both men and women. Participants will be 
recruited from a pool of approximately 50 individuals who have already been 
implanted in Cleveland with the Finetech-Brindley SARS system. Individuals who 
are already implanted with the SARS system receive regular follow-up contact 
regarding their system. Our clinical colleagues will ask them about their interest 
in this study.  Individuals who express interest will then be contacted by our study 
team for study enrollment. We conservatively estimate that at least 50% of these 
individuals can be reached for follow-up and 50% of those individuals will be 
willing to participate in this study. We have already received confirmation from 4 
such individuals of their interest in participating in this work. Therefore, we are 
confident that we will not have difficulty recruiting for this study. 
 
Study subjects will be compensated $75 for their participation via Greenphire 
ClinCard. This compensation rate is consistent with subject honoraria at our local 
site. They will receive Payment after each visit, including $25 if they complete the 
first visit and $50 if they complete the second visit. If the participants do not have 
a private vehicle, transportation will be provided to them. 
 
5.3 Informed Consent Procedures 
The PI (Dr. Bourbeau), or other staff authorized to obtain informed consent, will 
explain the study in person, answer questions, and obtain informed consent for 
participation in this study. The consent process will take place in privacy in a 
quiet room. The study goals and an overview of the experiment will be reviewed 
with each participant. Special care will be taken to inform the participant of all the 
potential risks of participation and that they may choose to withdraw from the 
study at any point. HIPAA guidelines will be followed by all study staff. For VA 
study participants, signed consent forms will be stored in a locked drawer in a 
locked room (B-E336). Consent will be obtained during the initial visit. The 
consent form will include contact information for the research team should the 
subject have further questions during the study. 
 
5.4 Inclusion/Exclusion Criteria 
Inclusion: 
• Uses a SARS System with rhizotomy for bladder management 
• Suprasacral SCI 
• Neurologically stable  
• Skeletally mature 
 
Exclusion: 
• Active, symptomatic urinary tract infection (UTI) 
• Active sepsis 
• Open pressure injuries on or around the pelvis 

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• Bleeding diathesis 
• Significant urethral trauma, erosion, or stricture 
 
 
5.5 Study Evaluations 
We will use standard clinical urodynamics methods for data collection. We will 
use an FDA-approved modified external controller to communicate with the 
already-implanted components of the system, so no new surgeries or other 
procedures are required. The device has been modified to achieve frequencies 
up to 600 Hz and this modification was approved by the FDA in an IDE. We will 
document their normal daily usage device settings for reference, including 
stimulation amplitude, pulse width, frequency, and on/off cycle duration. 
 
Clinical Urodynamics and Anorectal Manometry Procedure: A standard catheter 
will be inserted into the bladder via the urethra and the bladder will be emptied. 
This catheter will be removed and then a second catheter, which can measure 
bladder and urethral pressures, will be inserted. This catheter will also have a 
lumen for filling the bladder with sterile saline. A balloon catheter inserted in the 
rectum will be used to reflect abdominal pressure and distinguish bladder 
pressures due to detrusor contraction versus bladder pressures due to 
abdominal activity. This balloon catheter will measure rectal pressure. It will also 
have pressure transducers at the anal sphincter to measure anal sphincter 
pressure. Surface electromyogram (EMG) electrodes will be applied to the anal 
sphincter to monitor pelvic floor muscle contractions. Infused volumes will be 
controlled via an infusion pump. EMG and pressure signals will be monitored on 
a clinical urodynamic system. The participant’s bladder will be infused with sterile 
saline while measuring bladder, urethral sphincter, and rectal pressures.  
 
Sacral Anterior Root Stimulation: We will set the stimulation parameters for the 
implanted stimulator, including stimulation amplitude and frequency, using a 
modified Finetech-Brindley external controller unit. The frequency will be set 
either to 600 Hz or to the low frequency that the participant typically uses for 
emptying their bladder, which is usually 20 Hz. We will use the participant’s own 
power transmission coil. The receiver coil and electrodes will already have been 
implanted. The pulse width will not be changed from the participant’s normal 
setting. 
 
Aim 1: Determine if 600 Hz sacral root stimulation limits contraction of the 
urethral sphincter. 
 
During visit 2, in a single session, we will first administer SARS using the 
stimulation parameters (i.e., frequency, pulse width, and amplitude) that the 
study participant typically uses to empty their bladder and has been for years. 
The purpose is to characterize the usual level of urethral sphincter and bladder 
pressure during their bladder emptying routines and collect these baseline data. 

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We will also have a frame of reference for stimulation amplitude for testing 600 
Hz stimulation. 
 
We will then decrease the stimulation amplitude and identify the threshold 
amplitude to achieve urethral sphincter contraction at low frequency, which will 
be compared to the threshold amplitude to evoke bladder contraction. The motor 
efferents innervating the urethral sphincter are significantly larger in diameter 
than the motor efferents innervating the bladder, so the thresholds for activating 
the bladder are higher than for activating the urethral sphincter. These thresholds 
amplitudes at low frequency will give us additional context for evaluating the 
recruitment of urethral sphincter and bladder pressures in response to sacral 
stimulation. 
 
We will then test stimulation at 600 Hz. 600 Hz stimulation will first evoke a brief 
(~1-2 second) onset respond and then the urethral pressure is expected to return 
to baseline. The stimulation amplitude will be set to 0 mA and gradually 
increased to determine the threshold amplitude for evoking an initial onset 
response of the urethral sphincter. We will continue to increase the stimulation 
amplitude until we have achieved maximal urethral sphincter pressure onset 
response. Stimulation will be maintained for up to 10 seconds with at least 30 
seconds rest between stimuli. Once this recruitment curve is established, we will 
repeat stimulation at threshold, 50% maximal recruitment, and 90% maximal 
recruitment for up to 30 seconds to measure reduction of urethral sphincter 
pressures. 
 
Aim 2: Determine if 600 Hz sacral root stimulation limits contraction of the 
anal sphincter. 
 
This aim has the same design as Aim 1 but will focus on bowel function. Data for 
this aim will be measured during the same session as Aim 1. We will administer 
SARS using the stimulation parameters and pattern that the participant typically 
uses to empty their bowel and has been for years. These data will give us 
context for evaluating effects on bowel function. 
 
We will then test stimulation at 600 Hz. This testing can be done simultaneously 
with 600 Hz testing for Aim 1. The stimulation amplitude will be set to 0 mA and 
gradually increased to determine the threshold amplitude for evoking an initial 
onset response of the anal sphincter. We will continue to increase the stimulation 
amplitude until we have achieved maximal anal sphincter pressure onset 
response. Stimulation will be maintained for up to 10 seconds with at least 30 
seconds rest between stimuli. Once this recruitment curve is established, we will 
repeat stimulation at threshold, 50% maximal recruitment, and 90% maximal 
recruitment for up to 30 seconds to measure reduction of anal sphincter 
pressures. 
 
 

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5.6 Data Analysis 
Outcomes from urodynamics data will be used to determine the effect of 
electrical stimulation on limiting urethral and anal sphincter pressures. 
Distributions of pressures without and with 600 Hz and 20 Hz stimulation will be 
compared with an ANOVA and a significance level of 0.05. We expect to observe 
a lower level of urethral and anal sphincter pressure in response to sacral 
stimulation at frequencies of 600 Hz compared to the low stimulation frequency 
that participants typically use. 
 
Potential Limitations and Alternative Solutions 
If 600Hz sacral stimulation in humans fails to limit urethral and anal sphincter 
activity compared to what is evoked at low frequency, then we will need to 
consider alternative stimulation strategies in future studies. We acknowledge that 
another potential approach using kilohertz frequency stimulation could be 
considered. Our group and others have tested kilohertz frequency sinusoidal 
waveforms extensively preclinically to block nerve 
conduction. This could be another alternative to the rhizotomy, but it would 
require development and regulatory approval of a new implantable stimulation 
system that can safely deliver stimulation in the kilohertz frequency range for 
human testing [14]– [18]. 
 
We do not expect to experience significant technical challenges because (1) we 
are using a SARS system that study participants have been successfully using 
for years and (2) we are using research methods that we have successfully used 
for years to collect these data [19], [20]. We may find that the external controller 
does not deliver sufficient charge to achieve sphincter reduction at elevated 
stimulation frequencies. This is unlikely because the amplitude required to avoid 
contraction at 600Hz frequencies is not significantly higher than the amplitude to 
achieve activation at lower amplitudes. 
 
5.7 Withdrawal of Subjects 
There may be instances that would require investigators to terminate a 
participant’s participation in this study. Investigators will stop the experiment if the 
participant demonstrates any unresolved physical or psychological discomfort. 
 
6.0 
Risks  
 
Tissue Damage – rare. There is a small risk that the neural tissue may be 
damaged by the application of electrical stimulation. This risk will be minimized 
by applying stimulation within amplitude and duration parameters that were safe 
and effective in chronic preclinical experiments. 
 
Urinary tract infection: This risk is uncommon. There is a risk of less than 10% 
that a subject will develop a urinary tract infection (UTI) following urodynamics in 
this study. This risk will be minimized by performing catheterization with sterile 
technique and by taking antibiotics before and after the experiment as 

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prescribed. If a subject experiences signs or symptoms of a UTI (such as blood 
in the urine, frequency, urgency, increased spasms, fever, chills, and/or pain in 
the lower back) after the study, please contact a member of the study team. 
Subjects will be advised on how to proceed for medical treatment. 
 
Urethral trauma: This risk is uncommon. There is a small risk, which we estimate 
at approximately 2%, that a subject will experience mild trauma to the urethra as 
a result of catheterization for this study. Such trauma might result in a small 
amount of bleeding from the surface of the urethra, similar to that seen from the 
gums on vigorous tooth-brushing. This risk will be minimized by lubricating the 
catheter with sterile water-soluble gel and by careful catheterization technique. 
 
Discomfort during urodynamic testing: Subjects may experience some discomfort 
from lying down for up to four hours at a time during these procedures. If so, the 
investigators will assist subjects in changing position to become more 
comfortable. The investigators will assist subjects in changing position at least 
every 2 hours, if the procedures last that long, to reduce the risk of pressure 
injuries. 
 
Reproductive Health/Sexual Activity: The effects on the developing child of using 
electrical stimulation during pregnancy and the risk of birth defects are unknown. 
Therefore, women who are pregnant or breastfeeding may not participate in this 
study. 
 
7.0 
Reporting 
 
The investigators have participated in the necessary training activities related to human 
subject experimentation, protecting study volunteers in research, and passed required 
computerized training. Because this is a case series study, the primary concern is 
participant safety. The primary reporting channels within the VA will be used to assure 
study compliance and review of adverse events if they occur.  
 
8.0 
Privacy and Confidentiality 
 
Local and central VA data security standards and protocols will be observed. Research 
Records will be retained in accordance with RCS 10-1. Electronic data will be stored on 
a password-protected VA drive (R:/Bourbeau). Physical documents will be stored in a 
locked drawer in the PI's locked office in B-E336. All data will be de-identified. Data 
collected during the course of the study will be associated with subjects using distinct 
alpha-numeric codes and the encoding key will be securely stored.  
 
9.0 
Communication Plan 
 
The PI will complete reporting to oversight and regulatory bodies as required by 
standard procedures for these bodies, including but not limited to, Cleveland VA 

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Medical Center and its IRB, VA Central Office, and MetroHealth Medical Center and its 
IRB. PHI/PII will not be shared within this communication. 
 
 
 
 
 
10.0 References 
 
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and failures. Prog Brain Res. 2006;152:163-194. 
2. Stoffel JT. Detrusor sphincter dyssynergia: a review of physiology, diagnosis, and 
treatment strategies. Transl Androl Urol. 2016;5(1):127-135. 
3. Jamil F. Towards a catheter free status in neurogenic bladder dysfunction: a review 
of bladder management options in spinal cord injury (SCI). Spinal Cord. 2001;39(7):355-
361. 
4. Middleton JW, Lim K, Taylor L, Soden R, Rutkowski S. Patterns of morbidity and 
rehospitalization following spinal cord injury. Spinal Cord. 2004;42(6):359-367. 
5. French DD, Campbell RR, Sabharwal S, Nelson AL, Palacios PA, Gavin-Dreschnack 
D. Health care costs for patients with chronic spinal cord injury in the Veterans Health 
Administration. J Spinal Cord Med. 2007;30(5):477-481. 
6. Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J 
Neurotrauma. 2004;21(10):1371-1383. 
7. Bourbeau D, Bolon A, Creasey G, et al. Needs, priorities, and attitudes of individuals 
with spinal cord injury toward nerve stimulation devices for bladder and bowel function: 
a survey. Spinal Cord. 2020;58(11):1216-1226. 
8. Brindley GS. An implant to empty the bladder or close the urethra. J Neurol 
Neurosurg Psychiatry. 1977;40(4):358-369. 
9. MacDonagh RP, Forster DM, Thomas DG. Urinary continence in spinal injury patients 
following complete sacral posterior rhizotomy. Br J Urol. 1990;66(6):618-622. 
10. Sanders PMH, Ijzerman MJ, Roach MJ, Gustafson KJ. Patient preferences for next 
generation neural prostheses to restore bladder function. Spinal Cord. 2011;49(1):113-
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11. Abdel-Gawad M, Boyer S, Sawan M, Elhilali MM. Reduction of bladder outlet 
resistance by selective stimulation of the ventral sacral root using high frequency 
blockade: a chronic study in spinal cord transected dogs. J Urol. 2001;166(2):728-733. 
12. Thüroff JW, Bazeed MA, Schmidt RA, Wiggin DM, Tanagho EA. Functional pattern 
of sacral root stimulation in dogs. I. Micturition. J Urol. 1982;127(5):1031-1033. 
13. Li JS, Hassouna M, Sawan M, Duval F, Elhilali MM. Long-term effect of sphincteric 
fatigue during bladder neurostimulation. J Urol. 1995;153(1):238-242. 
14. Kilgore KL, Bhadra N. Nerve conduction block utilising high-frequency alternating 
current. Med Biol Eng Comput. 2004;42(3):394-406. 
15. Bhadra N, Kilgore KL. High-frequency electrical conduction block of mammalian 
peripheral motor nerve. Muscle Nerve. 2005;32(6):782-790. 

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16. Miles JD, Kilgore KL, Bhadra N, Lahowetz EA. Effects of ramped amplitude 
waveforms on the onset response of high-frequency mammalian nerve block. J Neural 
Eng. 2007;4(4):390-398. 
17. Boger A, Bhadra N, Gustafson KJ. Bladder voiding by combined high frequency 
electrical pudendal nerve block and sacral root stimulation. Neurourol Urodyn. 
2008;27(5):435-439. 
18. Franke M. Translating Electric KHFAC and DC Nerve Block from Research to 
Application. Published online 2014. 
19. Creasey GH, Grill JH, Korsten M, et al. An implantable neuroprosthesis for restoring 
bladder and bowel control to patients with spinal cord injuries: a multicenter trial. Arch 
Phys Med Rehabil. 2001;82(11):1512- 1519. 
20. Bourbeau DJ, Gustafson KJ, Brose SW. At-home genital nerve stimulation for 
individuals with SCI and neurogenic detrusor overactivity: A pilot feasibility study. J 
Spinal Cord Med. 2019;42(3):360-370.