NCT03083366

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

Terminated NA Results posted Last updated 10 June 2025

What this trial tests

NA trial testing PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) in Spinal Cord Injury, Acute in 5 participants. Terminated before completion.

Timeline

7 August 2019

Primary endpoint
20 April 2023

20 April 2023

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	5
Start date	7 August 2019
Primary completion	20 April 2023
Estimated completion	20 April 2023
Sites	2 locations across United States

Drugs / interventions tested

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

Conditions studied

• Spinal Cord Injury, Acute — all drugs for Spinal Cord Injury, Acute →
• Neurogenic Bladder — all drugs for Neurogenic Bladder →
• Incontinence — all drugs for Incontinence →
• Urinary Tract Infections — all drugs for Urinary Tract Infections →

Sponsor

University of Utah

Who can join

18 and older, any sex, with Spinal Cord Injury, Acute or Neurogenic Bladder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Cystometric Capacity Primary · 12 months

Maximum bladder capacity as measured by urodynamic study at 12 months

Group	Value	95% CI
Sacral Neuromodulation	400	± 0

Quality of Life Differences Measured by Mean SCI-QoL Primary · 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.

Group	Value	95% CI
Sacral Neuromodulation	130	± 0
Standard Care	180	± 0

Number of Urinary Tract Infections Requiring Antibiotics Primary · from enrollment through the end of follow-up at 12 months

Group	Value	95% CI
Sacral Neuromodulation	5
Standard Care	2

Maximum Cystometric Capacity at 3 Months Secondary · 3 months

Maximum bladder capacity as measured by urodynamic study at 3 months

Group	Value	95% CI
Sacral Neuromodulation	650	± 0
Standard Care	231	± 0

Bladder Compliance Secondary · 3, 12 months

Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.

3 months

Group	Value	95% CI
Sacral Neuromodulation	25	± 0
Standard Care	12.16	± 0

12 months

Group	Value	95% CI
Sacral Neuromodulation	NA

Presence of Detrusor Overactivity Secondary · 3, 12 months

Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.

3 months

Group	Value	95% CI
Sacral Neuromodulation	0
Standard Care	1

12 months

Group	Value	95% CI
Sacral Neuromodulation	0

Volume at First Detrusor Contraction Secondary · 3, 12 months

Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.

3 months

Group	Value	95% CI
Standard Care	164	± 0

Pressure at First Detrusor Contraction Secondary · 3, 12 months

Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.

3 months

Group	Value	95% CI
Standard Care	16	± 0

Daily Number of Catheterizations Secondary · 3, 6, 9, 12 months

Daily number of catheterizations as reported in the participant diary.

3 months

Group	Value	95% CI
Sacral Neuromodulation	4	± 0
Standard Care	2	± 0

6 months

Group	Value	95% CI
Sacral Neuromodulation	3.67	± 0

9 months

Group	Value	95% CI
Standard Care	6	± 0

12 months

Group	Value	95% CI
Sacral Neuromodulation	4	± 0

Average Catheterization Volume Secondary · 3, 6, 9, 12 months

Average catheterization volume as determined by participant diary.

3 months

Group	Value	95% CI
Sacral Neuromodulation	358.33	± 0
Standard Care	461.67	± 0

6 months

Group	Value	95% CI
Sacral Neuromodulation	400	± 0

9 months

Group	Value	95% CI
Standard Care	472.22	± 0

12 months

Group	Value	95% CI
Sacral Neuromodulation	79.42	± 0

Urinary Incontinence Episodes Per Day Secondary · 3, 6, 9, 12 months

Urinary incontinence episodes per day as determined by participant diary.

3 months

Group	Value	95% CI
Sacral Neuromodulation	0	± 0

6 months

Group	Value	95% CI
Sacral Neuromodulation	0	± 0

9 months

Group	Value	95% CI
Standard Care	0	± 0

12 months

Group	Value	95% CI
Sacral Neuromodulation	0	± 0

24 Hour Pad Weight Test Secondary · 3, 6, 9, 12 months

24 hour pad weight as determined by participant diary.

3 months

Group	Value	95% CI
Sacral Neuromodulation	0	± 0
Standard Care	0.81	± 0

6 months

Group	Value	95% CI
Sacral Neuromodulation	0	± 0

12 months

Group	Value	95% CI
Sacral Neuromodulation	0	± 0

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment to end of follow-up period at 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sacral Neuromodulation

Serious: 0/3 (0%)

Deaths: 0/3

Standard Care

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (1 terms — click to expand)

Reaction	System	Sacral Neuromodulation	Standard Care
Urinary tract infection	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT03083366 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury.
   Redshaw JD, Lenherr SM, Elliott SP, Stoffel JT, et al · · 2018 · cited 32× · PMID 30157824 · DOI 10.1186/s12894-018-0383-y
2. Established and Emerging Therapies in Acute Spinal Cord Injury.
   Gadot R, Smith DN, Prablek M, Grochmal JK, et al · · 2022 · cited 19× · PMID 35793931 · DOI 10.14245/ns.2244176.088
3. Neurogenic Lower Urinary Tract Dysfunction in the First Year After Spinal Cord Injury: A Descriptive Study of Urodynamic Findings.
   Kozomara M, Birkhäuser V, Anderson CE, Bywater M, et al · · 2023 · cited 12× · PMID 36263681 · DOI 10.1097/ju.0000000000003021