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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03083366
• Other study ID #: 96153
• Status: Terminated
• Phase: N/A
• Start date: August 7, 2019
• Est. completion date: April 20, 2023

Study information

• Verified date: July 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Ability to implant device less than 12 weeks post-SCI

• Presence of acute SCI at or above T12

• ASIA Scale A or B

• Expectation to perform 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

Related Conditions & MeSH terms

• Incontinence
• Neurogenic Bladder
• Spinal Cord Injuries
• Spinal Cord Injury, Acute
• Urinary Bladder, Neurogenic
• Urinary Tract Infections
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Rancho Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urodynamic determined maximum cystometric capacity		12 months
Primary	Quality of Life differences measured by mean SCI-QoL		3, 6, 9, 12 months
Primary	Number of urinary tract infections per year		12 months
Secondary	Urodynamics determined maximum cystometric capacity		3 months
Secondary	Urodynamics determined bladder compliance		3, 12 months
Secondary	Presence of detrusor overactivity during urodynamics		3, 12 months
Secondary	Urodynamics determined volume at first detrusor contraction		3, 12 months
Secondary	Urodynamics determined detrusor pressure at first detrusor contraction		3, 12 months
Secondary	Number of daily catheterizations		3, 6, 9, 12 months
Secondary	Average catheterization volume		3, 6, 9, 12 months
Secondary	Urinary incontinence episodes per day		3, 6, 9, 12 months
Secondary	24 hour pad weight test		3, 6, 9, 12 months
Secondary	Development of hydronephrosis		continous, 12 months
Secondary	Need for anticholinergic medication		continous, 12 months
Secondary	Need for onabotulinum toxin A injection		continous, 12 months
Secondary	Need for device revision		continous, 12 months
Secondary	Need for device explanation		continous, 12 months
Secondary	Hospitalizations		continous, 12 months
Secondary	Urologic related surgeries		continous, 12 months
Secondary	Death		continuous, 12 months