Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury. Within 12-weeks of injury, participants will either receive an implanted nerve stimulator (like a pace-maker for the bladder) or standard care for neurogenic bladder. Patients will be assigned to one of these groups at random and followed for one year. The hypothesis is that early stimulation of the nerves will help prevent the development of neurogenic bladder.

Official Title
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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

Conditions
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Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence, Urinary Tract Infections

Intervention / Treatment
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* Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized non-blinded study of sacral neuromodulation plus standard neurogenic bladder care versus standard neurogenic bladder care in patients with spinal cord injury
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sacral neuromodulation<br>Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care. | Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)<br>* Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)<br>* Other names: Sacral neuromodulation;|
| No Intervention: Standard care<br>Patients will receive standard neurogenic bladder care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic determined maximum cystometric capacity |  | 12 months | 
| Quality of Life differences measured by mean SCI-QoL |  | 3, 6, 9, 12 months | 
| Number of urinary tract infections per year |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamics determined maximum cystometric capacity |  | 3 months | 
| Urodynamics determined bladder compliance |  | 3, 12 months | 
| Presence of detrusor overactivity during urodynamics |  | 3, 12 months | 
| Urodynamics determined volume at first detrusor contraction |  | 3, 12 months | 
| Urodynamics determined detrusor pressure at first detrusor contraction |  | 3, 12 months | 
| Number of daily catheterizations |  | 3, 6, 9, 12 months | 
| Average catheterization volume |  | 3, 6, 9, 12 months | 
| Urinary incontinence episodes per day |  | 3, 6, 9, 12 months | 
| 24 hour pad weight test |  | 3, 6, 9, 12 months | 
| Development of hydronephrosis |  | continous, 12 months | 
| Need for anticholinergic medication |  | continous, 12 months | 
| Need for onabotulinum toxin A injection |  | continous, 12 months | 
| Need for device revision |  | continous, 12 months | 
| Need for device explanation |  | continous, 12 months | 
| Hospitalizations |  | continous, 12 months | 
| Urologic related surgeries |  | continous, 12 months | 
| Death |  | continuous, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, Neurogenic, bladder, electrical stimulation, neuromodulation