Incontinence, Neurogenic Bladder, Spinal Cord Injury, Acute, Urinary Tract Infections
Conditions
Keywords
spinal cord injury, Neurogenic, bladder, electrical stimulation, neuromodulation
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.
Interventions
DEVICEPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Sponsors
Rancho Research Institute, Inc.
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Ability to implant device less than 12 weeks post-spinal cord injury (SCI) * Presence of acute SCI at or above T12 * American Spinal Injury Association (ASIA) Scale A or B * Expectation to perform clean intermittent catheterization (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Cystometric Capacity | 12 months | Maximum bladder capacity as measured by urodynamic study at 12 months |
| Quality of Life Differences Measured by Mean SCI-QoL | 12 months | Participant-reported quality of life as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) bladder question banks at 12 months. Scores range from 64-320 with a lower score indicating greater satisfaction with quality of life. |
| Number of Urinary Tract Infections Requiring Antibiotics | from enrollment through the end of follow-up at 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume at First Detrusor Contraction | 3, 12 months | Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months. |
| Pressure at First Detrusor Contraction | 3, 12 months | Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months. |
| Daily Number of Catheterizations | 3, 6, 9, 12 months | Daily number of catheterizations as reported in the participant diary. |
| Average Catheterization Volume | 3, 6, 9, 12 months | Average catheterization volume as determined by participant diary. |
| Urinary Incontinence Episodes Per Day | 3, 6, 9, 12 months | Urinary incontinence episodes per day as determined by participant diary. |
| 24 Hour Pad Weight Test | 3, 6, 9, 12 months | 24 hour pad weight as determined by participant diary. |
| Development of Hydronephrosis | 12 months | Development of hydronephrosis during the study period as determined by ultrasound at 12 months. |
| Maximum Cystometric Capacity at 3 Months | 3 months | Maximum bladder capacity as measured by urodynamic study at 3 months |
| Need for Onabotulinum Toxin A Injection | from enrollment through the end of follow-up at 12 months | — |
| Need for Device Revision | from implant through the end of follow-up at 12 months | — |
| Device Explanation | from implant through the end of follow-up at 12 months | — |
| Hospitalizations | from enrollment through the end of follow-up at 12 months | — |
| Urologic Related Surgeries | from enrollment through the end of follow-up at 12 months | — |
| Death | from enrollment through the end of follow-up at 12 months | — |
| Need for Anticholinergic Medication | from enrollment through the end of follow-up at 12 months | — |
| Bladder Compliance | 3, 12 months | Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months. |
| Presence of Detrusor Overactivity | 3, 12 months | Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months. |
Countries
United States
Participant flow
Recruitment details
The study recruited participants from March 2019 to May 2022, with the first patient enrolled in August 2019. Patients were recruited from participating sites as well as online advertising.
Pre-assignment details
There was a screening phase in order to identify eligible participants.
Participants by arm
| Arm | Count |
|---|---|
| Sacral Neuromodulation Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN): Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) | 4 |
| Standard Care Patients will receive standard neurogenic bladder care. | 1 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Enrollment Period | Lack of Efficacy | 1 | 0 |
| Screening Period | Did not meet criteria (screen fail) | 1 | 0 |
Baseline characteristics
| Characteristic | Sacral Neuromodulation | Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 2 / 3 | 1 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Maximum Cystometric Capacity
Maximum bladder capacity as measured by urodynamic study at 12 months
Time frame: 12 months
Population: All participants who completed the study. Data only collected for one participant in the sacral neuromodulation group at 12 months because the other did not return for their 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sacral Neuromodulation | Maximum Cystometric Capacity | 400 mL | Standard Deviation 0 |
Primary
Number of Urinary Tract Infections Requiring Antibiotics
Time frame: from enrollment through the end of follow-up at 12 months
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacral Neuromodulation | Number of Urinary Tract Infections Requiring Antibiotics | 5 events |
| Standard Care | Number of Urinary Tract Infections Requiring Antibiotics | 2 events |
Primary
Quality of Life Differences Measured by Mean SCI-QoL
Participant-reported quality of life as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) bladder question banks at 12 months. Scores range from 64-320 with a lower score indicating greater satisfaction with quality of life.
Time frame: 12 months
Population: All participants who completed the study. Data only collected for one participant in the sacral neuromodulation group at 12 months because the other did not complete their 12 month questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sacral Neuromodulation | Quality of Life Differences Measured by Mean SCI-QoL | 130 score on a scale | Standard Deviation 0 |
| Standard Care | Quality of Life Differences Measured by Mean SCI-QoL | 180 score on a scale | Standard Deviation 0 |
Secondary
24 Hour Pad Weight Test
24 hour pad weight as determined by participant diary.
Time frame: 3, 6, 9, 12 months
Population: All participants who completed the 3 month study visit. Only one participant in the sacral neuromodulation group completed their diary entries, but did not complete the diary at 9 months. The participant in the standard care group did not complete this diary question at 6, 9, or 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sacral Neuromodulation | 24 Hour Pad Weight Test | 3 months | 0 oz | Standard Deviation 0 |
| Sacral Neuromodulation | 24 Hour Pad Weight Test | 6 months | 0 oz | Standard Deviation 0 |
| Sacral Neuromodulation | 24 Hour Pad Weight Test | 12 months | 0 oz | Standard Deviation 0 |
| Standard Care | 24 Hour Pad Weight Test | 3 months | 0.81 oz | Standard Deviation 0 |
Secondary
Average Catheterization Volume
Average catheterization volume as determined by participant diary.
Time frame: 3, 6, 9, 12 months
Population: All participants who completed the 3 month study visit. Only one participant in the sacral neuromodulation group completed their diary entries, but did not complete the diary at 9 months. The participant in the standard care group did not complete this diary question at 6 or 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sacral Neuromodulation | Average Catheterization Volume | 3 months | 358.33 mL | Standard Deviation 0 |
| Sacral Neuromodulation | Average Catheterization Volume | 6 months | 400 mL | Standard Deviation 0 |
| Sacral Neuromodulation | Average Catheterization Volume | 12 months | 79.42 mL | Standard Deviation 0 |
| Standard Care | Average Catheterization Volume | 3 months | 461.67 mL | Standard Deviation 0 |
| Standard Care | Average Catheterization Volume | 9 months | 472.22 mL | Standard Deviation 0 |
Secondary
Bladder Compliance
Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.
Time frame: 3, 12 months
Population: All participants who completed the 3 month study visit. Data only collected for one participant in the sacral neuromodulation group at 3 \& 12 months because the other did not return for their 3 or 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sacral Neuromodulation | Bladder Compliance | 3 months | 25 mL/cmH2O | Standard Deviation 0 |
| Sacral Neuromodulation | Bladder Compliance | 12 months | NA mL/cmH2O | — |
| Standard Care | Bladder Compliance | 3 months | 12.16 mL/cmH2O | Standard Deviation 0 |
Secondary
Daily Number of Catheterizations
Daily number of catheterizations as reported in the participant diary.
Time frame: 3, 6, 9, 12 months
Population: All participants who completed the 3 month study visit. Only one participant in the sacral neuromodulation group completed their diary entries, but did not complete the diary at 9 months. The participant in the standard care group did not complete this diary question at 6 or 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sacral Neuromodulation | Daily Number of Catheterizations | 3 months | 4 catheterizations per day | Standard Deviation 0 |
| Sacral Neuromodulation | Daily Number of Catheterizations | 6 months | 3.67 catheterizations per day | Standard Deviation 0 |
| Sacral Neuromodulation | Daily Number of Catheterizations | 12 months | 4 catheterizations per day | Standard Deviation 0 |
| Standard Care | Daily Number of Catheterizations | 3 months | 2 catheterizations per day | Standard Deviation 0 |
| Standard Care | Daily Number of Catheterizations | 9 months | 6 catheterizations per day | Standard Deviation 0 |
Secondary
Death
Time frame: from enrollment through the end of follow-up at 12 months
Population: All enrolled participants were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacral Neuromodulation | Death | 0 events |
| Standard Care | Death | 0 events |
Secondary
Development of Hydronephrosis
Development of hydronephrosis during the study period as determined by ultrasound at 12 months.
Time frame: 12 months
Population: All participants who completed the study. Data not collected for either group because participants in both groups did not return for their 12 month ultrasound.
Secondary
Device Explanation
Time frame: from implant through the end of follow-up at 12 months
Population: All participants who had device implanted were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacral Neuromodulation | Device Explanation | 1 events |
Secondary
Hospitalizations
Time frame: from enrollment through the end of follow-up at 12 months
Population: All enrolled participants were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacral Neuromodulation | Hospitalizations | 0 events |
| Standard Care | Hospitalizations | 0 events |
Secondary
Maximum Cystometric Capacity at 3 Months
Maximum bladder capacity as measured by urodynamic study at 3 months
Time frame: 3 months
Population: All participants who completed the 3 month study visit. Data only collected for one participant in the sacral neuromodulation group at 3 months because the other did not return for their 3 month UDS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sacral Neuromodulation | Maximum Cystometric Capacity at 3 Months | 650 mL | Standard Deviation 0 |
| Standard Care | Maximum Cystometric Capacity at 3 Months | 231 mL | Standard Deviation 0 |
Secondary
Need for Anticholinergic Medication
Time frame: from enrollment through the end of follow-up at 12 months
Population: All enrolled participants. Data not reported for one of the participants in the sacral neuromodulation group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sacral Neuromodulation | Need for Anticholinergic Medication | 0 Participants |
| Standard Care | Need for Anticholinergic Medication | 1 Participants |
Secondary
Need for Device Revision
Time frame: from implant through the end of follow-up at 12 months
Population: All participants who had the device implanted were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacral Neuromodulation | Need for Device Revision | 0 events |
Secondary
Need for Onabotulinum Toxin A Injection
Time frame: from enrollment through the end of follow-up at 12 months
Population: All enrolled participants. Data not reported for one of the participants in the sacral neuromodulation group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacral Neuromodulation | Need for Onabotulinum Toxin A Injection | 1 events |
| Standard Care | Need for Onabotulinum Toxin A Injection | 1 events |
Secondary
Presence of Detrusor Overactivity
Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.
Time frame: 3, 12 months
Population: All participants who completed the 3 month study visit. Data only collected for one participant in the sacral neuromodulation group at 3 \& 12 months because the other did not return for their 3 or 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sacral Neuromodulation | Presence of Detrusor Overactivity | 12 months | 0 events |
| Sacral Neuromodulation | Presence of Detrusor Overactivity | 3 months | 0 events |
| Standard Care | Presence of Detrusor Overactivity | 3 months | 1 events |
Secondary
Pressure at First Detrusor Contraction
Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.
Time frame: 3, 12 months
Population: All participants who completed the 3 month study visit. Data not collected for the sacral neuromodulation group at 3 \& 12 months because one participant did not return for their 3 or 12 month UDS and this specific data point was inadvertently not recorded for the other participant during their 3 or 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | Pressure at First Detrusor Contraction | 3 months | 16 cm H2O | Standard Deviation 0 |
Secondary
Urinary Incontinence Episodes Per Day
Urinary incontinence episodes per day as determined by participant diary.
Time frame: 3, 6, 9, 12 months
Population: All participants who completed the 3 month study visit. Only one participant in the sacral neuromodulation group completed their diary entries, but did not complete the diary at 9 months. The participant in the standard care group did not complete this diary question at 3, 6, or 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sacral Neuromodulation | Urinary Incontinence Episodes Per Day | 3 months | 0 incontinence episodes per day | Standard Deviation 0 |
| Sacral Neuromodulation | Urinary Incontinence Episodes Per Day | 6 months | 0 incontinence episodes per day | Standard Deviation 0 |
| Sacral Neuromodulation | Urinary Incontinence Episodes Per Day | 12 months | 0 incontinence episodes per day | Standard Deviation 0 |
| Standard Care | Urinary Incontinence Episodes Per Day | 9 months | 0 incontinence episodes per day | Standard Deviation 0 |
Secondary
Urologic Related Surgeries
Time frame: from enrollment through the end of follow-up at 12 months
Population: All enrolled participants were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sacral Neuromodulation | Urologic Related Surgeries | 0 events |
| Standard Care | Urologic Related Surgeries | 0 events |
Secondary
Volume at First Detrusor Contraction
Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.
Time frame: 3, 12 months
Population: All participants who completed the 3 month study visit. Data not collected for the sacral neuromodulation group at 3 \& 12 months because one participant did not return for their 3 or 12 month UDS and this specific data point was inadvertently not recorded for the other participant during their 3 or 12 month UDS. Data not collected for the participant in the standard of care group at 12 months because they did not return for their 12 month UDS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | Volume at First Detrusor Contraction | 3 months | 164 mL | Standard Deviation 0 |