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

June 9, 2025 updated by: Jeremy Myers, University of Utah

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Cystometric Capacity
Time Frame: 12 months
Maximum bladder capacity as measured by urodynamic study at 12 months
12 months
Quality of Life Differences Measured by Mean SCI-QoL
Time Frame: 12 months
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
Time Frame: from enrollment through the end of follow-up at 12 months
from enrollment through the end of follow-up at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Cystometric Capacity at 3 Months
Time Frame: 3 months
Maximum bladder capacity as measured by urodynamic study at 3 months
3 months
Bladder Compliance
Time Frame: 3, 12 months
Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.
3, 12 months
Presence of Detrusor Overactivity
Time Frame: 3, 12 months
Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.
3, 12 months
Volume at First Detrusor Contraction
Time Frame: 3, 12 months
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
Time Frame: 3, 12 months
Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.
3, 12 months
Daily Number of Catheterizations
Time Frame: 3, 6, 9, 12 months
Daily number of catheterizations as reported in the participant diary.
3, 6, 9, 12 months
Average Catheterization Volume
Time Frame: 3, 6, 9, 12 months
Average catheterization volume as determined by participant diary.
3, 6, 9, 12 months
Urinary Incontinence Episodes Per Day
Time Frame: 3, 6, 9, 12 months
Urinary incontinence episodes per day as determined by participant diary.
3, 6, 9, 12 months
24 Hour Pad Weight Test
Time Frame: 3, 6, 9, 12 months
24 hour pad weight as determined by participant diary.
3, 6, 9, 12 months
Development of Hydronephrosis
Time Frame: 12 months
Development of hydronephrosis during the study period as determined by ultrasound at 12 months.
12 months
Need for Anticholinergic Medication
Time Frame: from enrollment through the end of follow-up at 12 months
from enrollment through the end of follow-up at 12 months
Need for Onabotulinum Toxin A Injection
Time Frame: from enrollment through the end of follow-up at 12 months
from enrollment through the end of follow-up at 12 months
Need for Device Revision
Time Frame: from implant through the end of follow-up at 12 months
from implant through the end of follow-up at 12 months
Device Explanation
Time Frame: from implant through the end of follow-up at 12 months
from implant through the end of follow-up at 12 months
Hospitalizations
Time Frame: from enrollment through the end of follow-up at 12 months
from enrollment through the end of follow-up at 12 months
Urologic Related Surgeries
Time Frame: from enrollment through the end of follow-up at 12 months
from enrollment through the end of follow-up at 12 months
Death
Time Frame: from enrollment through the end of follow-up at 12 months
from enrollment through the end of follow-up at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rancho Research Institute, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeremy B Myers, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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