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

NCT03083366 | Terminated Results DMC FDA Device

• 1 other identifier: 96153
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

spinal cord injury; Neurogenic; bladder; electrical stimulation; neuromodulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Maximum Cystometric Capacity at 3 Months

  3 months

• Bladder Compliance

  3, 12 months

• Presence of Detrusor Overactivity

  3, 12 months

• Volume at First Detrusor Contraction

  3, 12 months

• Pressure at First Detrusor Contraction

  3, 12 months

Study Arms (2)

Sacral neuromodulation

EXPERIMENTAL

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)

Standard care

NO INTERVENTION

Patients will receive standard neurogenic bladder care.

Interventions

PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) DEVICE

Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)

Also known as: Sacral neuromodulation

Sacral neuromodulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Rancho Research Institute, Inc.: collaborator

Study Sites (2)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 30157824 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Bladder, Neurogenic; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Limitations and Caveats

Target enrollment was not met and the study was terminated early. Due to the small number of subjects enrolled, there was insufficient data to achieve target power and statistically reliable results. Also, data were not collected for all participants at all study timepoints resulting in an incomplete dataset and uninterpretable data.

Results Point of Contact

• Title: Karena McDonald
• Organization: University of Utah

karena.mcdonald@hsc.utah.edu

801-699-9740

Study Officials

• Jeremy B Myers, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: Randomized non-blinded study of sacral neuromodulation plus standard neurogenic bladder care versus standard neurogenic bladder care in patients with spinal cord injury

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: March 20, 2017
• Study Start: August 7, 2019
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)