Spinal Cord Injury, AcuteNCT03083366

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

A study testing PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) in people with Spinal Cord Injury, Acute and Neurogenic Bladder, run by University of Utah at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence
What is being tested?: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 2 sitesUnited States
Study dates: 7 Aug 2019to 20 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence, Urinary Tract Infections
Being tested: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Keywords: spinal cord injury, Neurogenic, bladder, electrical stimulation, neuromodulation
Medical subject headings: Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03083366
Study group	Role	What they receive
Sacral neuromodulation	Experimental	Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care. Receives: Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Standard care	No intervention	Patients will receive standard neurogenic bladder care.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (17)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 201920 Apr 2023

First posted20 Mar 2017
Study start7 Aug 2019
Primary completion20 Apr 2023
Study completion20 Apr 2023

Why it stopped: The study was unable to meet enrollment goals

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Spinal Cord Injury, AcuteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03083366
Sponsor's protocol ID: 96153
Status last verified: Jun 2025
First submitted: 27 Jan 2017
Last updated: 10 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 30157824

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
NG004 in Incomplete Spinal Cord Injury Patients
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
Recruiting
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial
Spinal Cord Injuries, Spinal Cord Injury (SCI), Initial Encounter
RecruitingPhase 1
Safety of CRT100 on Treatment Spinal Cord Injury
Thoracic Spinal Cord Injury
Not yet recruitingEarly Phase 1
Cardiocentric Inotropic Optimization in Spinal Cord Injury
SCI - Spinal Cord Injury
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence

All Spinal Cord Injury, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
ClinicalTrials.gov ID: NCT03083366
Acronym / sponsor ID: 96153
Conditions: Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence, Urinary Tract Infections
Keywords: spinal cord injury, Neurogenic, bladder, electrical stimulation, neuromodulation
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was unable to meet enrollment goals
Enrolment: 5 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: Rancho Research Institute, Inc.
Study start: 7 Aug 2019 (actual)
Primary completion: 20 Apr 2023 (actual)
Study completion: 20 Apr 2023 (actual)
First posted: 20 Mar 2017 (actual)
Results: Posted 10 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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

Arm	Type	Receives
Sacral neuromodulation	Experimental	Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
Standard care	No intervention	–Patients will receive standard neurogenic bladder care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (14 listed)

Inability to perform CIC
Pre-existing SCI
Pre-existing progressive neurological disorder
Autonomic dysreflexia
Prior sacral back surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)Also: Sacral neuromodulationBilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)	Device	Sacral neuromodulation

Primary outcome

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

17 secondary outcomes

Maximum Cystometric Capacity at 3 Months
Time frame: 3 months
Bladder Compliance
Time frame: 3, 12 months
Presence of Detrusor Overactivity
Time frame: 3, 12 months
Volume at First Detrusor Contraction
Time frame: 3, 12 months
Pressure at First Detrusor Contraction
Time frame: 3, 12 months
Daily Number of Catheterizations
Time frame: 3, 6, 9, 12 months
Average Catheterization Volume
Time frame: 3, 6, 9, 12 months
Urinary Incontinence Episodes Per Day
Time frame: 3, 6, 9, 12 months
24 Hour Pad Weight Test
Time frame: 3, 6, 9, 12 months
Development of Hydronephrosis
Time frame: 12 months
Need for Anticholinergic Medication
Time frame: 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
Need for Device Revision
Time frame: 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
Hospitalizations
Time frame: 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
Death
Time frame: from enrollment through the end of follow-up at 12 months

Results and safety

Results posted to the registry on 10 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sacral Neuromodulation	4	3
Standard Care	1	1

Primary outcome: Maximum Cystometric Capacity

Time frame: 12 months. Mean (Standard Deviation). Unit: mL

Measure	Sacral Neuromodulation n = 1	Standard Care n = 0
Value	400 (0)	–

Population analysed: All participants who completed the study. Data only collected for one participant in the sacral neuromodulation group at 12 months because the other did not return for their 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.

Primary outcome: Quality of Life Differences Measured by Mean SCI-QoL

Time frame: 12 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Sacral Neuromodulation n = 1	Standard Care n = 1
Value	130 (0)	180 (0)

Primary outcome: Number of Urinary Tract Infections Requiring Antibiotics

Time frame: from enrollment through the end of follow-up at 12 months. Number. Unit: events

Measure	Sacral Neuromodulation n = 3	Standard Care n = 1
Value	5	2

Population analysed: All enrolled participants.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to end of follow-up period at 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sacral Neuromodulation	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Standard Care	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30157824Redshaw 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.
Individual participant dataSharing planned: No

Related trials for Spinal Cord Injury, Acute

RecruitingPhase 1
NG004 in Incomplete Spinal Cord Injury Patients
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
Recruiting
Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial
Spinal Cord Injuries, Spinal Cord Injury (SCI), Initial Encounter
RecruitingPhase 1
Safety of CRT100 on Treatment Spinal Cord Injury
Thoracic Spinal Cord Injury
Not yet recruitingEarly Phase 1
Cardiocentric Inotropic Optimization in Spinal Cord Injury
SCI - Spinal Cord Injury
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeremy B Myers, MD principal investigator

University of Utah

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Cystometric Capacity (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03083366, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.