NCT03083366

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

The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2019-08-07
• Primary completion: 2023-04-20
• Completion: 2023-04-20
• First posted: 2017-03-20
• Last updated: 2025-06-10
• Results posted: 2025-06-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study