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

The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury

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 Overview

• Status: Terminated
• Conditions: Urinary Tract Infections; Neurogenic Bladder; Incontinence; Spinal Cord Injury, Acute
• Intervention / Treatment: Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitation Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacral neuromodulation; 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); Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN); Other Names: Sacral neuromodulation
No Intervention: Standard care; Patients will receive standard neurogenic bladder care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Cystometric Capacity	Maximum bladder capacity as measured by urodynamic study at 12 months	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.	12 months
Number of Urinary Tract Infections Requiring Antibiotics		from enrollment through the end of follow-up at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Cystometric Capacity at 3 Months	Maximum bladder capacity as measured by urodynamic study at 3 months	3 months
Bladder Compliance	Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.	3, 12 months
Presence of Detrusor Overactivity	Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.	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.	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.	3, 12 months
Daily Number of Catheterizations	Daily number of catheterizations as reported in the participant diary.	3, 6, 9, 12 months
Average Catheterization Volume	Average catheterization volume as determined by participant diary.	3, 6, 9, 12 months
Urinary Incontinence Episodes Per Day	Urinary incontinence episodes per day as determined by participant diary.	3, 6, 9, 12 months
24 Hour Pad Weight Test	24 hour pad weight as determined by participant diary.	3, 6, 9, 12 months
Development of Hydronephrosis	Development of hydronephrosis during the study period as determined by ultrasound at 12 months.	12 months
Need for Anticholinergic Medication		from enrollment through the end of follow-up at 12 months
Need for Onabotulinum Toxin A Injection		from enrollment through the end of follow-up at 12 months
Need for Device Revision		from implant through the end of follow-up at 12 months
Device Explanation		from implant through the end of follow-up at 12 months
Hospitalizations		from enrollment through the end of follow-up at 12 months
Urologic Related Surgeries		from enrollment through the end of follow-up at 12 months
Death		from enrollment through the end of follow-up at 12 months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Rancho Research Institute, Inc.
• Investigators: Principal Investigator: Jeremy B Myers, MD, University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Actual): April 20, 2023
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (Actual): March 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: electrical stimulation; neuromodulation; spinal cord injury; bladder; Neurogenic
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Trauma, Nervous System; Urinary Bladder Diseases; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Urinary Tract Infections; Urinary Bladder, Neurogenic
• Other Study ID Numbers: 96153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes