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

Utah System of Higher Education (USHE)

Status: Terminated

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

Treatments: Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)

Study type: Interventional

Funder types: Other

Identifiers

NCT03083366

96153

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Ability to implant device less than 12 weeks post-spinal cord injury (SCI)
• Presence of acute SCI at or above T12
• American Spinal Injury Association (ASIA) Scale A or B
• Expectation to perform clean intermittent catheterization (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Sacral neuromodulation

Experimental group

Description:

Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.

Treatment:

Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)

Standard care

No Intervention group

Description:

Patients will receive standard neurogenic bladder care.