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

University of Utah5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury, Acute Neurogenic Bladder Incontinence Urinary Tract Infections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Maximum Cystometric Capacity

Maximum bladder capacity as measured by urodynamic study at 12 months

Time frame: 12 months

Quality of Life Differences Measured by Mean SCI-QoL

Participant-reported quality of life as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) bladder question banks at 12 months. Scores range from 64-320 with a lower score indicating greater satisfaction with quality of life.

Time frame: 12 months

Number of Urinary Tract Infections Requiring Antibiotics

Time frame: from enrollment through the end of follow-up at 12 months

Secondary Outcomes

Maximum Cystometric Capacity at 3 Months

Maximum bladder capacity as measured by urodynamic study at 3 months

Time frame: 3 months

Bladder Compliance

Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.

Time frame: 3, 12 months

Presence of Detrusor Overactivity

Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.

Time frame: 3, 12 months

Volume at First Detrusor Contraction

Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.

Time frame: 3, 12 months

Pressure at First Detrusor Contraction

Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.

Time frame: 3, 12 months

Daily Number of Catheterizations

Daily number of catheterizations as reported in the participant diary.

Time frame: 3, 6, 9, 12 months

Average Catheterization Volume

Average catheterization volume as determined by participant diary.

Time frame: 3, 6, 9, 12 months

Urinary Incontinence Episodes Per Day

Urinary incontinence episodes per day as determined by participant diary.

Time frame: 3, 6, 9, 12 months

24 Hour Pad Weight Test

24 hour pad weight as determined by participant diary.

Time frame: 3, 6, 9, 12 months

Development of Hydronephrosis

Development of hydronephrosis during the study period as determined by ultrasound at 12 months.

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes