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

NCT03083366 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-06-10

Study results available
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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

Interventions

DEVICE

PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)

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

Sponsors & Collaborators

Principal Investigators

  • Jeremy B Myers, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-07
Primary Completion
2023-04-20
Completion
2023-04-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083366 on ClinicalTrials.gov