Clinical trial NCT03083366: Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury
Official title: The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury, Acute
Neurogenic Bladder
Incontinence
Urinary Tract Infections
Keywords: spinal cord injury
Neurogenic
bladder
electrical stimulation
neuromodulation
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Rancho Research Institute, Inc.
First posted: 2017-03-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Cystometric Capacity
timeFrame: 12 months
measure: Quality of Life Differences Measured by Mean SCI-QoL
timeFrame: 12 months
measure: Number of Urinary Tract Infections Requiring Antibiotics
timeFrame: from enrollment through the end of follow-up at 12 months
Secondary outcomes:
measure: Maximum Cystometric Capacity at 3 Months
timeFrame: 3 months
measure: Bladder Compliance
timeFrame: 3, 12 months
measure: Presence of Detrusor Overactivity
timeFrame: 3, 12 months
measure: Volume at First Detrusor Contraction
timeFrame: 3, 12 months
measure: Pressure at First Detrusor Contraction
timeFrame: 3, 12 months
measure: Daily Number of Catheterizations
timeFrame: 3, 6, 9, 12 months
measure: Average Catheterization Volume
timeFrame: 3, 6, 9, 12 months
measure: Urinary Incontinence Episodes Per Day
timeFrame: 3, 6, 9, 12 months
measure: 24 Hour Pad Weight Test
timeFrame: 3, 6, 9, 12 months
measure: Development of Hydronephrosis
timeFrame: 12 months
measure: Need for Anticholinergic Medication
timeFrame: from enrollment through the end of follow-up at 12 months
measure: Need for Onabotulinum Toxin A Injection
timeFrame: from enrollment through the end of follow-up at 12 months
measure: Need for Device Revision
timeFrame: from implant through the end of follow-up at 12 months
measure: Device Explanation
timeFrame: from implant through the end of follow-up at 12 months
measure: Hospitalizations
timeFrame: from enrollment through the end of follow-up at 12 months
measure: Urologic Related Surgeries
timeFrame: from enrollment through the end of follow-up at 12 months
measure: Death
timeFrame: from enrollment through the end of follow-up at 12 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jeremy B Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redshaw JD, Lenherr SM, Elliott SP, Stoffel JT, Rosenbluth JP, Presson AP, Myers JB; Neurogenic Bladder Research Group (NBRG.org). Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury. BMC Urol. 2018 Aug 29;18(1):72. doi: 10.1186/s12894-018-0383-y.