The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
Phase: NA
Conditions: Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence, Urinary Tract Infections
Sponsor: University of Utah

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The Effectiveness of Early Sacral Nerve Stimulation in 
Improving Bladder- 
Related Complications and Quality of Life after Acute 
Traumatic Spinal Cord 
Injury (Central IRB) 
 
Protocol Summary 
 
 
 
IRB Approval Date of Current Version: 12/21/2018 
University of Utah IRB #: IRB_00096153 
Sponsor: DOD DEFENSE ADVANCED RESRCH PRJCTS 
AGCY 
  
Principal Investigator: Jeremy Myers 
Internal Staff and  Sub-Investigators: 
Sara Lenherr 
Jeff Redshaw 
Ashlea Wilkes 
External Sub-Investigators: 
Sean Elliott  
Spendley James  
Ian Schwartz  
John Stoffel  
 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

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Background and Introduction 
 
University of Utah is the Central IRB. 
  
Urinary bladder dysfunction and incontinence have a significant clinical, physical, 
and quality of life (QoL) burden in patients with spinal cord injury (SCI). 
Contemporary studies reports bladder problems are the second leading reason 
SCI patients seek medical care. Nearly 250,000 Americans live with SCI and 
approximately 74-80% of SCI patients report some degree of bladder dysfunction 
within 1 year of injury1-4. In addition, spinal trauma was present in 11% of all 
injuries sustained by military personal deployed to Iraq and Afghanistan; 9% of 
those injuries resulted in significant spinal cord injury5. The average age of those 
injured with spinal trauma was 27 years, meaning that there is a high current 
prevalence and future burden of wounded American Veterans with bladder 
dysfunction due to spinal cord injury. 
Loss of descending input from the spinal cord results in predictable changes in 
the neurological control of bladder function6. Normal bladder control is a balance 
of the sympathetic and parasympathetic nervous systems. The sympathetic 
system is tonically active the majority of time and allows storage of urine and 
maintains continence. Conversely, when the parasympathetic nervous system is 
activated, bladder contraction occurs allowing for bladder emptying7. There are 
two types of afferent nerve fibers (those that carry nerve impulses from the 
bladder to the central nervous system), A-delta fibers and C-fibers. Under 
normal physiological conditions, bladder distention activates A-delta fibers, which 
triggers a spinobulbospinal micturition reflex and allows voiding. The other type 
of afferent fibers (C-fibers) are silent during normal voiding 8. Injury to the spinal 
cord above the sacral segments interrupts the connection between the brain and 
spinal autonomic centers and interrupts any ability to volitionally void. 
Immediately after SCI, the bladder becomes flaccid or atonic. Over the next 
several weeks following injury, neuroplasticity alters bladder afferents causing a 
proliferation of C-fiber afferent fibers within the lining of the bladder or the 
urothelium. As a result, a new C-fiber-mediated voiding reflex emerges and 
becomes sensitive to bladder distention, while the A-delta fiber afferent input 
becomes ineffective at allowing the bladder to store urine. The end result of 
these changes is a bladder that spasms leading to urinary leakage at even low 
volumes and has poor compliance such that it will not store a normal amount of 
urine. Depending on the location of the spinal injury, detrusor-sphincterdyssynergia 
(DSD) may also occur. When DSD occurs, the bladder and the 
urinary sphincter contract simultaneously during a bladder spasm resulting in 
high bladder pressures due to increased outlet resistance. 
Collectively these changes in the neurological control of the bladder comprise the 
development of the clinical neurogenic bladder (NGB). Patients with NGB carry a 
heavy burden of disease and over 42% of SCI patients are hospitalized for 
urinary problems every year 4. The goals of NGB management are wellestablished 
in the literature: (1) prevention of kidney damage or failure by 

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keeping bladder pressures low (2) preservation of urinary continence and (3) 
optimizing quality of life. Clinicians use anticholinergic medications or 
onabotulinum toxin A to relax or paralyze the bladder musculature and minimize 
bladder spasticity. By decreasing bladder spasticity, a low-pressure system is 
established, which protects renal function and allows patients to store urine 
without significant incontinence. Patients must also employ some form of 
assisted bladder emptying, such as an indwelling catheter or clean intermittent 
catheterization (CIC) to drain the bladder. These strategies can significantly 
reduce urinary complications and related hospitalizations, especially in those 
patients who tolerate the medications and have the dexterity to perform CIC 
independently. However, there is a significant inconvenience, potential 
dependence on others, and often continued leakage that leads to patient noncompliance 
and discontinuation of CIC4,9,10. Patients who fail these less invasive 
treatments may require surgical bladder augmentation or urinary diversion in 
order to preserve renal function11. Bladder augmentation and urinary diversion 
surgery are both effective, but are associated with significant surgical morbidity 
and a 1-3% risk of death from complications. Furthermore patients often require 
additional surgical care during their lifetime to maintain their complex 
reconstructed urinary system12. 
Complications associated with NGB dysfunction and management. In the past, 
renal failure and urinary sepsis were the major causes of death in SCI patients 
after recovery from initial injury13. However, advances in urologic care, 
specifically the introduction of CIC in the 1970’s revolutionized the care of SCI 
patients14,15. In contemporary studies, the leading causes of death in SCI patients 
are now pneumonia and influenza rather than renal failure16-18. As a result of 
longer life expectancy, the chronic complications of NGB management are more 
prevalent and cause significant morbidity19. Five primary risks of NGB 
dysfunction and associated management are described below, namely: urinary 
tract infection, urinary calculi, bladder cancer, renal dysfunction and pressure 
ulcers. 
Urinary tract infection (UTI): Between 20-56% of persons with SCI experience a 
UTI annually20,21. UTIs are associated with a high rate of hospitalization. The 
urinary tract of most SCI patients is chronically colonized despite meticulous technique with 
CIC. Persons with SCI are at high risk for symptomatic UTIs and 
sepsis because of the structural and functional urinary tract abnormalities (e.g., 
elevated urine storage pressures, vesicoureteral reflux) that often accompany 
SCI. 
Urinary calculi: Renal calculi are common in patients with SCI with a 7-20% risk 
of developing a stone over a period of 8-10 years22-24, significantly higher than in 
the general population25. SCI-associated stones are frequently large, can require 
multiple procedures to treat and have a high incidence of recurrence26. Renal 
calculi are associated with an increased odds of death (OR 1.3, 95%CI 1.0-1.7) 
18. Bladder calculi are also frequent in SCI, with reported prevalence rates of 18- 
65%27 and pathogenesis attributed to foreign bodies (either chronic indwelling or 
CIC), urinary stasis and infection28. Management of urinary calculi in patients with 
SCI carries a higher risk of urosepsis and respiratory failure than the same 

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procedures in the general population. This morbidity is directly associated with 
the level of SCI injury29. 
Bladder cancer: The risk of bladder cancer is elevated in SCI patients, especially 
when managed with an indwelling catheter30. The relative risk of bladder cancer 
is 4.9 (95% CI 1.3-13.8) in those SCI patients managed with an indwelling 
catheter as compared to those without indwelling catheters31. In SCI, bladder 
cancer also typically presents at a younger age and more advanced stage, so 
survival is poor compared with the general population30,32,33. 
Renal dysfunction: Historically, renal failure was a frequent cause of mortality in 
SCI, but has significantly improved bladder pressure management. In addition to 
chronic health conditions, renal failure in SCI results from recurrent UTIs and 
pyelonephritis, urinary calculi, hydronephrosis and NGB dysfunction. Current 
prevalence of chronic kidney disease (eGFR <60ml/min/1.73 m2) in the US 
veterans administration SCI population is 10.2%. 
Pressure ulcers (PrU): The relationship between NGB dysfunction, bladder 
management method and PrU is less direct. Bladder and bowel incontinence 
have been suggested as risk factors for PrU in some studies but not in others34- 
36. A proposed mechanism of PrU resulting from incontinence is wetness of the 
skin resulting in softening of the protective nature of the dermis and accelerating 
the impact of pressure on the skin, an effect which is more pronounced when the 
wetness is due to urine37. PrU prevalence is 39% over three years in Veterans 
with SCI38, and grade 3-4 PrU are well established risk factors for mortality in 
SCI18. 
Previous study of NGB treatment has focused on how to best control pressures 
in the bladder, as well as minimize complications once chronic NGB dysfunction 
has developed after the acute phase of SCI has past. Very few studies have 
attempted to prevent or ameliorate the adverse sequelae of NGB dysfunction in 
the acute phase of SCI. Since chronic NGB cannot be reversed, prevention of 
the development of some of the worst aspects of NGB such as high pressures 
and spasticity may be the next best strategy. 
Sacral neuromodulation (SNM) is an available technology, which may mitigate 
the effects of SCI on the bladder. Over the past 20 years SNM has become an 
established treatment for refractory urinary urge incontinence, urinary 
frequency/urgency syndrome, non-obstructive idiopathic urinary retention and 
chronic fecal incontinence39-42. Since first FDA approval in 1997 for refractory 
urinary urge incontinence, more than 40,000 people have been implanted with 
SNM devices43. The surgical procedure is minimally invasive and has very few 
risks. A quadripolar electrode is placed with fluoroscopic guidance adjacent to 
the S3 nerve routes within the sacral foramen. An internal pulse generator (IPG), 
much like a cardiac pacemaker, is connected to the electrode and the S3 nerve 
is stimulated with varying patterns and intensity. The mechanism of action of 
neuromodulation in humans is not well understood, but it is thought to be through 
the same afferent sensory nerve fibers (A-delta and C), which are implicated in 
the development of NGB. 
Sacral neuromodulation has a very well established track record in the treatment 
of patients with non-neurogenic urinary and fecal dysfunction. In the US, the 

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InterStim Therapy System (Medtronic, Minneapolis, MN, USA) has been FDA 
approved for use in idiopathic overactive bladder (OAB) since 1997, urinary 
frequency/urgency syndrome and non-obstructive idiopathic urinary retention 
since 1999, and for chronic fecal incontinence since 201144. Efficacy is well 
established for all three uses. In idiopathic OAB, SNM achieves sustained 
therapeutic success in 85% of patients with a greater than 60% reduction in leaks 
per day. From a quality of life standpoint, 80% of subjects report significant 
improvement in their urinary symptoms45. Similar improvements with SNM are 
noted when treating chronic fecal incontinence, with 86% of patients achieving 
therapeutic success. In this study, patients had decrease in fecal incontinence 
episodes from a mean of 9.4 at baseline to 1.7, which was durable after 3 years 
of follow up46. 
While the effectiveness of SNM has been well established in non-neurogenic 
disorders variable success has been achieved in the treatment of chronic NBG47- 
52. In regards to the treatment of neurogenic overactivity specifically, results from 
several studies demonstrate improvement40,53. In one study of 39 patients with 
mixed NGB etiologies, 80% of patients were able to achieve complete continence 
and 43% no longer required anticholinergic medications40. Both bladder capacity 
and bladder compliance have also been shown to improve with SNM. Chartier- 
Kastler et al were able to demonstrate a mean increase in bladder capacity of 
~206 ml in a population of partial SCI patients who had motor function below their 
injury. SNM in patients with NGB from multiple sclerosis (MS) has been the most 
studied indication and group in the literature. SNM has been found to reduce 
frequency of voids per day, reduce incontinence by 4-10 episodes per day, and 
increase voided volume by 77-84mL per void in this popultation54,55. Multiple 
studies in MS patients also cite significant improvements in quality of life and 
patient satisfaction of 75-86%54-56. Importantly, treatment failure in patients with 
progressive neurologic diseases (such as MS) is thought to be due to disease 
progression rather than device failure, something that is not present in SCI. The 
current data in the NGB patient population needs to be interpreted with caution 
however, due to heterogeneous patient populations, small sample sizes, and lack 
of randomization. Prospective controlled trials are needed. A randomized clinical 
trial with a goal enrollment of 54 subjects is currently ongoing to further establish 
the ideal chronic NGB patient population for SNM57. An important aspect of the 
treatment of patients with chronic NGB with SNM is that largely the patient 
groups have good motor function, which is thought to be a fair proxy for a largely 
intact spinal cord. For instance, ability to ambulate with good motor function 
below injury or disease has been an important predictor in some studies for 
success of the procedure. 
Despite the success of the above studies in selected populations of patients with 
chronic NGB, once changes in the neurological control of the bladder have 
occurred following SCI they are mostly irreversible. In chronic NGB, treatments 
must be directed at the local muscle level in order to control the high bladder 
pressures, incontinence and other symptoms. Consequently, the majority of 
research into the effects of spinal cord injury on the urinary bladder has focused 
on patients with well-established chronic neurogenic bladder physiology. 

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Interventions during the acute phase of SCI aimed at preventing the development 
of, or reducing the symptoms of NGB, remain an understudied area of research. 
  
 
 
 
Purpose and Objectives 
 
AIM 1: To determine the effect of sacral neuromodulation on urodynamic 
parameters following acute spinal cord injury. The following outcomes will be 
evaluated by urodynamic assessment at one year post-SCI: (1) maximum 
cystometric capacity, (2) bladder compliance, (3) presence of detrusor 
overactivity, and (4) volume and pressure for first detrusor contraction. 
AIM 2: To assess the impact of sacral neuromodulation on patient-reported 
quality of life after acute spinal cord injury. Patient-reported QoL will be 
assessed using the SCI-QOL bladder question bank and bladder/voiding diaries 
(Appendix B). Mean SCI-QOL score, daily number of catheterizations, average 
catheterization volume, and episodes of incontinence per day will be compared 
between groups at one year post-SCI. 
AIM 3: To examine the impact of sacral neuromodulation on quantifiable 
clinical outcomes. Patients will be followed longitudinally during the study 
period and assessed for the following: (1) need for anti-cholinergic medications 
and/or onabotulinum toxin A treatment, (2) number of symptomatic UTIs per 
year, (3) complications attributable to the device, (4) need for revision of device 
or leads due to lead migration or failure, (5) development of hydronephrosis. 
 
 
 
Study Population 
 
Age of Participants: 18+ 
 
Sample Size: 
At Utah: 
20  
All Centers: 
60 
 
Inclusion Criteria: 
Inclusion Criteria 
Age > 18 years 
Ability to implant device less than 12 weeks post-SCI 
Presence of acute SCI at or above T12 
ASIA Scale A or B 
Expectation to perform CIC personally or have caretaker perform CIC 

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Exclusion Criteria: 
Exclusion Criteria 
Inability to perform CIC 
Pre-existing SCI 
Pre-existing progressive neurological disorder 
Autonomic dysreflexia 
Prior sacral back surgery 
Posterior pelvic fracture with distortion of the sacroiliac joint 
Prior urethral sphincter or bladder dysfunction 
Chronic urinary tract infections prior to SCI 
Pregnancy at the time of enrollment 
Presence of coagulation disorder or need for anticoagulation that they 
cannot be stopped temporarily for procedure 
Any significant co-morbidity or illness that would preclude their 
participation or increase the risk to them having a surgical procedure 
Active untreated infection 
Traumatic injury to the genitourinary system 
Prior pelvic radiation, bladder cancer or other surgical procedure to the 
bladder that would effect baseline bladder physiology 
 
 
Design  
 
Prospective Clinical Research 
Randomized 
Phase I Clinical Trial 
 
 
 
 
Study Procedures 
 
Recruitment/Participant Identification Process: 
PI and Research coordinators/Assistants will review charts for study eligibility. Then patients 
will be consented by a member of the study team. 
We have also created flyers to be left in clinics with information about the study.  The flyers 
will contain the coordinators contact information and inclusion/exclusion details about the 
study. 
We will also recruit with the assistance via a Facebook advertisement.  The Facebook ad will 
route to the NBRG.org site, Neurogenic Bladder Research Group, which is a site maintained 
by the study PI Jeremy Myers.  All site PI's are part of the Neurogenic Bladder Research 
Group.  The Facebook ad will route to a page that contains 2 educational videos about the 
study, as well as the inclusion and exclusion information and a form to complete if someone 
is interested in participating in the study.  Once the potential participant enters their 

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information and clicks on "Submit" button, the completed form information will be emailed 
directly to ashlea.wilkes@hsc.utah, Ashlea Wilkes, who is the research coordinator at the 
University of Utah.  Ashlea Wilkes will be responsible to responding to all inquiries about the 
study via the Facebook advertisement. 
We have had success with previous studies involving participants with a spinal cord injury 
with advertising through Facebook.  The advertisement will allow us to reach a larger 
population of possible participants and their friends and family. 
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
Patients will be identified and consented in physical medicine and Rehab or neurosurgery or 
Urology clinics.  
 
Description of the consent process(es), including the timing of consent:  
Once screened for inclusion and exclusion criteria (see above), patients will be approached 
and asked if they would like to participate in a randomized, non-blinded study within 12 
weeks of the acute spinal cord injury event. Participants screened online through the Facebook 
advertisement will still require to be seen by the the site PI in clinic prior to consent to the 
study. They will then be given study material and informational video and allowed sufficient 
time to make an informed decision regarding participation. In the event that the participant is 
unable to read or sign the consent form because the participant is illiterate, visually impaired, 
or physically unable to sign, we will use a witness to confirm the consent process and 
sign/date the consent form. Not only will this help us achieve enrollment goals, but it will 
ensure patient safety and prevent discrimination. 
 
Procedures: 
PI and Research coordinators/Asistants will review charts for study eligibility. Future participants will have a choice to view 
an information video about the study.  Then patients will be consented by a member of the study team. 
Pregnant women will be excluded from participation. Women who are at risk of pregnancy 
will be asked to have a pregnancy test before taking part to exclude the possibility of 
pregnancy. Women of childbearing potential must use an effective contraceptive during the 
course of this study. Acceptable methods of birth control include abstinence, oral 
contraceptives, the contraceptive patch, the contraceptive ring and condoms. 
60 patients will be enrolled and randomized (30 per arm) to either standard 
neurogenic bladder management or standard management plus implantation of 
the Medtronic PrimeAdvanced Surescan 97702 Neurostimulator. 
All patients will receive usual standard of care bladder management for 
neurogenic bladder. Specifically, standard treatment entails the following: (1) CIC 
at regular timed intervals if the patient is physically able to do so, if not able to 
physically perform self catheterization patients will have the option to have this 
performed by a caregiver (2) treatment with anticholinergic medicine or 
onabotulinum toxin A as indicated to increase bladder compliance, decrease 
urinary leakage, and lower bladder pressures to prevent renal damage, (3), 
undergo routine follow up in the urology and physical medicine and rehabilitation 
clinic, (4) upper tract imaging (typically consisting of a renal ultrasound) will be 

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performed at one year follow-up to monitor for the development of 
hydronephrosis, (5) and serum creatinine as an estimate of renal function will be 
collected annually per recommended screening protocols.62 
  
The PrimeAdvanced Surescan 97702 Neurostimulator is an implantable device 
marketed by Medtronic (Minneapolis, MN) for use in the United States. It has 
several components: a internal pulse generator (IPG) which delivers an electrical 
signal to the sacral nerve; a quadripolar electrical lead that is implanted 
alongside the S3 nerve root; and a programmer that is used to control the 
electrical pulse delivered by the IPG. The IPG and the lead are permanent 
implants. The programmer is a handheld device that is not implanted. The 
PrimeAdvanced 97702 is an FDA approved device for spinal cord stimulation 
rather than sacral nerve root stimulation, which is the intention of this study. The 
PrimeAdvanced 97702 is conceptually and functionally, similar to the InterStim II 
Model3058 neurostimulator which is FDA approved for sacral neurostimulation in 
the United States. Unlike the Interstim II, the PrimeAdvanced has the ability to 
accommodate and simultaneously stimulate bilateral leads. All the preliminary 
studies in acute spinal cord injury have utilized bilateral sacral stimulation. 
A standardized surgical procedure will be implemented across all three study 
centers. Specifically, all patients will receive pre-procedural antibiotics of weightbased 
dosed Vancomycin and Gentamycin unless allergy precludes use of these 
antibiotics. In those cases, Clindamycin or other broad-spectrum antibiotics will 
be used. All antibiotics will be administered within 60 minutes of incision. 
Depending on patient factors, the procedure will be performed under either local 
or general anesthesia. All cases will have a surgical prep consisting of betadine 
scrub and paint over the surgical site followed by chlorhexadine prep application. 
Surgical transparent drape will be used to cover the surgical field and still allow 
for visualization of perianal area. Antibiotic irrigation will be used for all steps of 
the procedure. We will localize the S3 foramen with fluoroscopy and the tined 
lead will be placed with the curved stylet after demonstration of an optimal motor 
response (anal bellows). Importantly, tined lead stimulation of the S3 nerve roots 
activates striated fibers via efferent motor nerves. This pathway remains intact 
even during spinal shock when the spinal reflex arc is inactive. Therefore, the 
method to perform lead placement can proceed as in a neurologically intact 
patient. Tined leads will be placed bilaterally. Both leads will be tunneled to a 
subcutaneous pocket located in a non-pressure bearing location depending on 
patient body habitus, generally near the posterior iliac crest or anterior abdomen. 
Leads will be attached to the Prime Advanced IPG. We will permanently save 
fluoroscopic images in the lateral and anterior-posterior position to allow for 
comparison in case of suspected lead migration. Patients will take oral 
cephalosporin or equivalent for 7 days post-operatively. 
NOTE: Implantation is usually accomplished via a two-step process involving a 
placement of the permanent quadripolar electrode alongside the S3 nerve root 
under local or general anesthesia. This permanent lead is controlled by a 
temporary external programming device for 7-14 days. If greater than 50% 
improvement in clinical symptoms over that test period, the IPG is implanted 
subcutaneously under during a second surgical procedure. Because the study 
hypothesis dictates early stimulation of the sacral nerve roots with a primary 
outcome evaluated one year post implant, the quadripolar electrical lead and IPG 
will be placed in the same procedure. This will avoid delay in stimulation of the 
sacral nerves during the critical window for preventing adverse neuroplastic 
changes. Patients will be mostly insensate due to their SCI or being under 
general anesthesia for the procedure. Therefore, to confirm intraoperative 
placement we will rely upon expected motor responses (anal bellows and toe 
flexion). If correct motor responses cannot be elicited intraoperatively than the 
patients will not undergo implantation and will be included in the randomized arm 

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but in an ‘intention-to-treat’ manner. 
  
FDA approved programming parameters for the Interstim II system will be utilized 
in this study as follows. The device will provide continuous stimulation (i.e. 
always on) without discrete treatment periods. The PrimeAdvanced Surescan 
IPG is capable of generating a maximum voltage of 10.5 volts, 2 volts higher than 
the Interstim II system, however, it will be programed to function within the 
normal Interstim II system parameters (maximum 8.5 volts). Additionally, it will be 
programed to use the same stimulation pulsewidth (210 msec) and frequency 
(14Hz) as the Interstim II system. The area under the stimulation curve will be the 
same or less than intended by the Interstim II parameters. 
Each patient will be evaluated intraoperatively as is standard clinical practice to 
select stimulation parameters that result in typical, consistent physiological 
responses (e.g. anal bellows and first toe rotation). The default 14 Hz frequency 
will be maintained. The electrode with the lowest amplitude stimulation as a 
proxy for the most closely placed electrode to the S3 nerve. This electrode be 
trialed first. The stimulation amplitude will be set at 0.7V per protocol as was 
utilized in the one prior bilateral SNM study in acute SCI. Note: If the subject has 
S3 sensation (incomplete SCI), the amplitude will be set 0.1V lower than the level 
of sensation. In such sensate patients, each lead will be programmed individually 
and then both leads will be activated simultaneously to determine whether further 
amplitude reduction is needed. These parameters will be set during the initial 
programming session and will remain constant for the duration of the study. All 
study centers will utilize the same protocol. 
  
Standardized demographic data based on the National Institutes of Neurological 
Disorders and Stroke (NINDS) Common Data Elements (CDEs) will be collected 
via patient interview and evaluation of the electronic medical record including 
mechanism of SCI and medical comorbidities. All measured outcomes are listed 
in Table 1 by Aim. At enrollment, all participants will complete the following: (1) 
standardized 3-day voiding diary to annotate the catheterization time, amount 
and time of fluid intake, and incontinence events, (2) 24 hour pad weight test, (3) 
3-day bowel diary to quantify baseline bowel habits; (4) inventory of current 
medications; and (5) the SCI-QOL questionnaires (Appendix B). (6) 24 hour pad 
weight test averaged over 3 days. Repeat measurements will be obtained during 
clinic visits at 3, 6, 9, and 12 months after enrollment. (7) All participants will 
undergo baseline urodynamic testing at enrollment. For patients randomized to 
the intervention arm, urodynamic testing will be completed less than 2 weeks 
before implantation of the device. Urodynamic testing will be repeated at 3 
months and then again at 12 months. 
At each time point, a retrospective review since the prior time point will be 
performed in order to capture major events such as hospitalizations, additional 
surgery or death as well as additional subjective data. Those additional 
subjective data will include: (1) current usage of anti-cholinergic medications 
and/or onabotulinum toxin A treatment (2) number of culture proven symptomatic 
UTIs per year (3) complications attributable to the device, (4) need for revision of 
device or leads. 
A renal ultrasound will be obtained at the end of 12 months to evaluate for the 
development of hydronephrosis. This will be compared with baseline CT or US 
imaging obtained during their initial trauma evaluation. 
  
There will be a video available for participants to view for additional information. 
  

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Procedures performed for research purposes only:  
Implantation of sacral neuromodulator and leads 
 
 
Statistical Methods, Data Analysis and Interpretation 
 
Sample size calculations for this study were based on a mean maximum 
cystometric capacity of 220.7 mL (SD=103.3), as reported by Sievert et al 60, and 
a feasibility of enrolling 30 patients per arm within the study period. After 
accounting for a 15% loss to follow-up we expect 25 evaluable patients per arm. 
To achieve 80% power at a 5% significance level with 25 patients per arm 
(N=50), we can detect an effect size of a 38% treatment effect (84 mL increase in 
capacity). This calculation was simulated for a two-tailed t-test incorporating one 
interim and one final look at the data using the O'Brien and Fleming (OBF) 
method and running 50000 simulations (using PASS v. 11.0.8 software). An 
interim analysis will be conducted at 50% enrollment (N=26 after loss to followup, 
13 patients per arm) accrual, and the decision to stop early will be governed 
by an OBF significance level of 0.003. A 0.051 significance level will be used to 
evaluate the final analysis. The DSMB's decision to stop early will be guided 
both by interim results and clinical judgment, especially in the context of 
emerging, relevant literature.