Trial Outcomes & Findings for Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury (NCT NCT04736849)
NCT ID: NCT04736849
Last Updated: 2026-07-16
Results Overview
Percent change in EMG voltage from beginning to end of intervention, recorded from the rectus femoris, during epidural and dorsal root spinal stimulation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).
Results posted on
2026-07-16
Participant Flow
Participants were recruited from the following: * Mayo Clinic's volunteer research participant database * Mayo Clinic's clinical trials website * Mayo Clinic's electronic medical record database * ClinicalTrials.gov
Participant milestones
| Measure |
Cohort 1: Motor Complete SCI
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
4
|
|
Overall Study
COMPLETED
|
16
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Cohort 1: Motor Complete SCI
n=18 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=4 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
19 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
22 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Assessed at Day 1 (beginning of intervention) and Day 10 (end of intervention).Percent change in EMG voltage from beginning to end of intervention, recorded from the rectus femoris, during epidural and dorsal root spinal stimulation.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=15 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=4 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Electromyography
Epidural stimulation
|
-51 Percent change
Standard Deviation 52
|
-47 Percent change
Standard Deviation 39
|
|
Electromyography
Dorsal root stimulation
|
-16 Percent change
Standard Deviation 16
|
-15 Percent change
Standard Deviation 75
|
PRIMARY outcome
Timeframe: Assessed at Day 10 (end of intervention).Measurements of foot pressure from shoe-insole sensors during no-stimulation bilaterally assisted standing and unassisted standing with stimulation.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=2 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=1 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Foot Pressure
Stimulation off
|
34 Pounds of force
Standard Deviation 28
|
50 Pounds of force
Standard Deviation 0
|
|
Foot Pressure
Stimulation on
|
44 Pounds of force
Standard Deviation 39
|
56.5 Pounds of force
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).Change from baseline to end of study, in amplitude of evoked potentials recorded from sensory cortex using skin surface electrodes during electrical stimulation of the right and left tibial nerve.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=15 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=4 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Somatosensory Evoked Potentials
Left tibial nerve stimulation evoked response recorded from scalp
|
0.01 microvolt
Standard Deviation 0.13
|
0.05 microvolt
Standard Deviation 0.1
|
|
Somatosensory Evoked Potentials
Right tibial nerve stimulation evoked response recorded from scalp
|
-0.17 microvolt
Standard Deviation 2.14
|
-0.55 microvolt
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).Change in intensity of stimulation, reported as percentage (0% to 100%) of maximum system output, required to elicit motor-evoked potentials below the level of injury.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=12 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=3 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Transcranial Magnetic Stimulation Motor Evoked Potentials
|
-8 Percent
Standard Deviation 22.6
|
-20 Percent
Standard Deviation 36.7
|
PRIMARY outcome
Timeframe: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).Severity of spinal cord injury impairment will be assessed at baseline and end of study to examine changes in impairment that may be associated with the intervention.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=15 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=3 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
American Spinal Injury Association Grading Scale
Improvement in ASIA grade
|
1 Participants
|
0 Participants
|
|
American Spinal Injury Association Grading Scale
Decline in ASIA grade
|
0 Participants
|
0 Participants
|
|
American Spinal Injury Association Grading Scale
No change
|
14 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is averaged by total positive or negative score divided by the number of applicable answers.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=14 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=4 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Spasticity
|
0.4 SCI-SET score
Standard Deviation 0.7
|
0 SCI-SET score
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Assessed at Day 10 (end of intervention).Population: Due to severity of impairment, it was not feasible for some participants to perform the modified functional reach test.
On Day 10 (end of intervention), trunk balance was assessed with and without stimulation during attempts to reach forward using the modified functional reach test.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=12 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=3 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Modified Functional Reach Test
Stimulation off
|
13 centimeters
Standard Deviation 13.1
|
30 centimeters
Standard Deviation 18.8
|
|
Modified Functional Reach Test
Stimulation on
|
27.3 centimeters
Standard Deviation 18.1
|
41.8 centimeters
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=16 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=4 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Patient-reported Bowel Function
|
-1 NBDS score
Standard Deviation 4.8
|
-0.5 NBDS score
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=16 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=4 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Patient-reported Bladder Function
|
0.8 NBSS Score
Standard Deviation 6.8
|
-1.5 NBSS Score
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=13 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=3 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Male Patient-reported Sexual Function (SHIM)
|
1 SHIM score
Standard Deviation 3.1
|
-2.3 SHIM score
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Captured during screening assessments and at end of study (i.e., before day 1 and after day 10 of intervention).Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=13 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=3 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Male Patient-reported Sexual Function (IEF)
|
-0.2 IIEF score
Standard Deviation 7.9
|
-15.7 IIEF score
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Assessed at end of study ( after day 10 of intervention).Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item.
Outcome measures
| Measure |
Cohort 1: Motor Complete SCI
n=16 Participants
Participants with motor complete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of A or B.
|
Cohort 2: Motor Incomplete SCI
n=4 Participants
Participants with motor incomplete SCI due to trauma located at or above the tenth thoracic vertebrae.
American Spinal Injury Association grading scale of C or D.
|
|---|---|---|
|
Neurostimulation User Experience
|
2.1 UEQ Score
Standard Deviation 0.4
|
1.7 UEQ Score
Standard Deviation 0.4
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=18 participants at risk
Motor complete SCI
|
Cohort 2
n=4 participants at risk
Motor incomplete SCI
|
|---|---|---|
|
Injury, poisoning and procedural complications
Stuck leads
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
Other adverse events
| Measure |
Cohort 1
n=18 participants at risk
Motor complete SCI
|
Cohort 2
n=4 participants at risk
Motor incomplete SCI
|
|---|---|---|
|
Nervous system disorders
Autonomic dysreflexia
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Nervous system disorders
Brain fog
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Shin bruising
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin laceration
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Injury, poisoning and procedural complications
Post surgical pain
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
General disorders
Nausea
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Cardiac disorders
High blood pressure
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Urine incontinence
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Bladder incontinence
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Posterior heel blister
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Bilateral LE edema
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Blood in catheter
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Left posterior knee bruise
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin cut
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Increase urine urgency
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Nervous system disorders
Ache in back
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Decreased urine flow pressure
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Urine leakage
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Infections and infestations
Fever
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Breakdown
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Right trunk skin abrasion
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Injury, poisoning and procedural complications
Possible CSF leak
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Nervous system disorders
Autonomic Dysreflexia
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Increased bladder urgency
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
General disorders
Excessive sweating
|
0.00%
0/18 • From enrollment to end-of-study, approximately 3 weeks.
|
25.0%
1/4 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Gastrointestinal disorders
Bowel incontinence
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Cardiac disorders
Elevated blood pressure
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Skin and subcutaneous tissue disorders
Heel blisters
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Incontinence-bowel and bladder
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Renal and urinary disorders
Bladder leak
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
|
Infections and infestations
Low-grade fever
|
5.6%
1/18 • Number of events 1 • From enrollment to end-of-study, approximately 3 weeks.
|
0.00%
0/4 • From enrollment to end-of-study, approximately 3 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place