Trial Outcomes & Findings for Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury (NCT NCT03083366)

Results Overview

Maximum bladder capacity as measured by urodynamic study at 12 months

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

12 months

Results posted on

2025-06-10

Participant Flow

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.

There was a screening phase in order to identify eligible participants.

Participant milestones

Participant milestones
Measure	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)	Standard Care Patients will receive standard neurogenic bladder care.
Screening Period STARTED	4	1
Screening Period COMPLETED	3	1
Screening Period NOT COMPLETED	1	0
Enrollment Period STARTED	3	1
Enrollment Period COMPLETED	2	1
Enrollment Period NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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)	Standard Care Patients will receive standard neurogenic bladder care.
Screening Period Did not meet criteria (screen fail)	1	0
Enrollment Period Lack of Efficacy	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Maximum bladder capacity as measured by urodynamic study at 12 months

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care Patients will receive standard neurogenic bladder care.
Maximum Cystometric Capacity	400 mL Standard Deviation 0	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Quality of Life Differences Measured by Mean SCI-QoL	130 score on a scale Standard Deviation 0	180 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: from enrollment through the end of follow-up at 12 months

Population: All enrolled participants.

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=3 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Number of Urinary Tract Infections Requiring Antibiotics	5 events	2 events

SECONDARY outcome

Timeframe: 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.

Maximum bladder capacity as measured by urodynamic study at 3 months

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Maximum Cystometric Capacity at 3 Months	650 mL Standard Deviation 0	231 mL Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Bladder Compliance 3 months	25 mL/cmH2O Standard Deviation 0	12.16 mL/cmH2O Standard Deviation 0
Bladder Compliance 12 months	NA mL/cmH2O Data collected was determined to be invalid due to grossly out of range value.	—

SECONDARY outcome

Timeframe: 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.

Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Presence of Detrusor Overactivity 3 months	0 events	1 events
Presence of Detrusor Overactivity 12 months	0 events	—

SECONDARY outcome

Timeframe: 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.

Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.

Outcome measures

Outcome measures
Measure	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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Volume at First Detrusor Contraction 3 months	—	164 mL Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.

Outcome measures

Outcome measures
Measure	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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Pressure at First Detrusor Contraction 3 months	—	16 cm H2O Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Daily number of catheterizations as reported in the participant diary.

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Daily Number of Catheterizations 3 months	4 catheterizations per day Standard Deviation 0	2 catheterizations per day Standard Deviation 0
Daily Number of Catheterizations 6 months	3.67 catheterizations per day Standard Deviation 0	—
Daily Number of Catheterizations 9 months	—	6 catheterizations per day Standard Deviation 0
Daily Number of Catheterizations 12 months	4 catheterizations per day Standard Deviation 0	—

SECONDARY outcome

Timeframe: 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.

Average catheterization volume as determined by participant diary.

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Average Catheterization Volume 3 months	358.33 mL Standard Deviation 0	461.67 mL Standard Deviation 0
Average Catheterization Volume 6 months	400 mL Standard Deviation 0	—
Average Catheterization Volume 9 months	—	472.22 mL Standard Deviation 0
Average Catheterization Volume 12 months	79.42 mL Standard Deviation 0	—

SECONDARY outcome

Timeframe: 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.

Urinary incontinence episodes per day as determined by participant diary.

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
Urinary Incontinence Episodes Per Day 3 months	0 incontinence episodes per day Standard Deviation 0	—
Urinary Incontinence Episodes Per Day 6 months	0 incontinence episodes per day Standard Deviation 0	—
Urinary Incontinence Episodes Per Day 9 months	—	0 incontinence episodes per day Standard Deviation 0
Urinary Incontinence Episodes Per Day 12 months	0 incontinence episodes per day Standard Deviation 0	—

SECONDARY outcome

Timeframe: 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.

24 hour pad weight as determined by participant diary.

Outcome measures

Outcome measures
Measure	Sacral Neuromodulation n=1 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.
24 Hour Pad Weight Test 6 months	0 oz Standard Deviation 0	—
24 Hour Pad Weight Test 3 months	0 oz Standard Deviation 0	0.81 oz Standard Deviation 0
24 Hour Pad Weight Test 12 months	0 oz Standard Deviation 0	—

SECONDARY outcome

Timeframe: 12 months

Sacral Neuromodulation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sacral Neuromodulation n=3 participants at risk 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)	Standard Care n=1 participants at risk Patients will receive standard neurogenic bladder care.
Renal and urinary disorders Urinary tract infection	66.7% 2/3 • Number of events 5 • From enrollment to end of follow-up period at 12 months Adverse events were collected via participant query, questionnaire, and laboratory testing.	100.0% 1/1 • Number of events 2 • From enrollment to end of follow-up period at 12 months Adverse events were collected via participant query, questionnaire, and laboratory testing.

Additional Information

Karena McDonald

University of Utah

Phone: 801-699-9740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sacral Neuromodulation n=4 Participants 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)	Standard Care n=1 Participants Patients will receive standard neurogenic bladder care.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants