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

Primary Purpose

Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury, Acute focused on measuring spinal cord injury, Neurogenic, bladder, electrical stimulation, neuromodulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rancho Los Amigos National Rehabilitation Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sacral neuromodulation

Standard care

Arm Description

Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.

Patients will receive standard neurogenic bladder care.

Outcomes

Primary Outcome Measures

Urodynamic determined maximum cystometric capacity
Quality of Life differences measured by mean SCI-QoL
Number of urinary tract infections per year

Secondary Outcome Measures

Urodynamics determined maximum cystometric capacity
Urodynamics determined bladder compliance
Presence of detrusor overactivity during urodynamics
Urodynamics determined volume at first detrusor contraction
Urodynamics determined detrusor pressure at first detrusor contraction
Number of daily catheterizations
Average catheterization volume
Urinary incontinence episodes per day
24 hour pad weight test
Development of hydronephrosis
Need for anticholinergic medication
Need for onabotulinum toxin A injection
Need for device revision
Need for device explanation
Hospitalizations
Urologic related surgeries
Death

Full Information

First Posted
January 27, 2017
Last Updated
July 13, 2023
Sponsor
University of Utah
Collaborators
Rancho Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03083366
Brief Title
Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury
Official Title
The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was unable to meet enrollment goals
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
April 20, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Rancho Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Acute, Neurogenic Bladder, Incontinence, Urinary Tract Infections
Keywords
spinal cord injury, Neurogenic, bladder, electrical stimulation, neuromodulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sacral neuromodulation
Arm Type
Experimental
Arm Description
Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients will receive standard neurogenic bladder care.
Intervention Type
Device
Intervention Name(s)
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Other Intervention Name(s)
Sacral neuromodulation
Intervention Description
Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Primary Outcome Measure Information:
Title
Urodynamic determined maximum cystometric capacity
Time Frame
12 months
Title
Quality of Life differences measured by mean SCI-QoL
Time Frame
3, 6, 9, 12 months
Title
Number of urinary tract infections per year
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Urodynamics determined maximum cystometric capacity
Time Frame
3 months
Title
Urodynamics determined bladder compliance
Time Frame
3, 12 months
Title
Presence of detrusor overactivity during urodynamics
Time Frame
3, 12 months
Title
Urodynamics determined volume at first detrusor contraction
Time Frame
3, 12 months
Title
Urodynamics determined detrusor pressure at first detrusor contraction
Time Frame
3, 12 months
Title
Number of daily catheterizations
Time Frame
3, 6, 9, 12 months
Title
Average catheterization volume
Time Frame
3, 6, 9, 12 months
Title
Urinary incontinence episodes per day
Time Frame
3, 6, 9, 12 months
Title
24 hour pad weight test
Time Frame
3, 6, 9, 12 months
Title
Development of hydronephrosis
Time Frame
continous, 12 months
Title
Need for anticholinergic medication
Time Frame
continous, 12 months
Title
Need for onabotulinum toxin A injection
Time Frame
continous, 12 months
Title
Need for device revision
Time Frame
continous, 12 months
Title
Need for device explanation
Time Frame
continous, 12 months
Title
Hospitalizations
Time Frame
continous, 12 months
Title
Urologic related surgeries
Time Frame
continous, 12 months
Title
Death
Time Frame
continuous, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy B Myers, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30157824
Citation
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.
Results Reference
derived

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

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