Sacral Nerve Stimulation in Improving Bladder Function Af... | NCT03083366

Status Module

Name	Class
Rancho Research Institute, Inc.	OTHER

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sacral neuromodulation	Experimental	Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.	Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Standard care	No Intervention	Patients will receive standard neurogenic bladder care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)	Device	Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Cystometric Capacity	Maximum bladder capacity as measured by urodynamic study at 12 months	12 months
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.	12 months
Number of Urinary Tract Infections Requiring Antibiotics		from enrollment through the end of follow-up at 12 months

Secondary Outcomes

Measure	Description	Time Frame
Maximum Cystometric Capacity at 3 Months	Maximum bladder capacity as measured by urodynamic study at 3 months	3 months
Bladder Compliance	Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jeremy B Myers, MD	University of Utah	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Rancho Los Amigos National Rehabilitation Center		Downey	California	90242	United States
University of Utah

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30157824	Derived	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.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 21, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
BG000	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)
BG001	Standard Care	Patients will receive standard neurogenic bladder care.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0004 BG0011 BG0025

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0004 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Cystometric Capacity

Maximum bladder capacity as measured by urodynamic study at 12 months

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.

Posted

Mean

Standard Deviation

12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG0001 OG0010

Title

Denominators

Categories

Title	Measurements
	OG000400± 0

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.

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.

Posted

Mean

Standard Deviation

score on a scale

12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants

Primary

Number of Urinary Tract Infections Requiring Antibiotics

All enrolled participants.

Posted

Number

events

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

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Maximum Cystometric Capacity at 3 Months

Maximum bladder capacity as measured by urodynamic study at 3 months

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.

Posted

Mean

Standard Deviation

3 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Bladder Compliance

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

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.

Posted

Mean

Standard Deviation

mL/cmH2O

3, 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants

Secondary

Presence of Detrusor Overactivity

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

Posted

Number

events

3, 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants

Secondary

Volume at First Detrusor Contraction

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

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.

Posted

Mean

Standard Deviation

3, 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts

Secondary

Pressure at First Detrusor Contraction

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

Posted

Mean

Standard Deviation

cm H2O

3, 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts

Secondary

Daily Number of Catheterizations

Daily number of catheterizations as reported in the participant diary.

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.

Posted

Mean

Standard Deviation

catheterizations per day

3, 6, 9, 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants

Secondary

Average Catheterization Volume

Average catheterization volume as determined by participant diary.

Posted

Mean

Standard Deviation

3, 6, 9, 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants

Secondary

Urinary Incontinence Episodes Per Day

Urinary incontinence episodes per day as determined by participant diary.

Posted

Mean

Standard Deviation

incontinence episodes per day

3, 6, 9, 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants

Secondary

24 Hour Pad Weight Test

24 hour pad weight as determined by participant diary.

Posted

Mean

Standard Deviation

3, 6, 9, 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Development of Hydronephrosis

Development of hydronephrosis during the study period as determined by ultrasound at 12 months.

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.

Posted

12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Need for Anticholinergic Medication

All enrolled participants. Data not reported for one of the participants in the sacral neuromodulation group.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Need for Onabotulinum Toxin A Injection

All enrolled participants. Data not reported for one of the participants in the sacral neuromodulation group.

Posted

Number

events

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

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Need for Device Revision

All participants who had the device implanted were included.

Posted

Number

events

from implant through the end of follow-up at 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Device Explanation

All participants who had device implanted were included.

Posted

Number

events

from implant through the end of follow-up at 12 months

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Hospitalizations

All enrolled participants were included.

Posted

Number

events

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

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Urologic Related Surgeries

All enrolled participants were included.

Posted

Number

events

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

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Secondary

Death

All enrolled participants were included.

Posted

Number

events

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

ID	Title	Description
OG000	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)
OG001	Standard Care	Patients will receive standard neurogenic bladder care.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)	0	3	0	3	2	3
EG001	Standard Care	Patients will receive standard neurogenic bladder care.	0	1	0	1	1	1

Target enrollment was not met and the study was terminated early. Due to the small number of subjects enrolled, there was insufficient data to achieve target power and statistically reliable results. Also, data were not collected for all participants at all study timepoints resulting in an incomplete dataset and uninterpretable data.

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System
D014947	Wounds and Injuries
D009461	Neurologic Manifestations
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections

ID	Term
D013119	Spinal Cord Injuries
D001750	Urinary Bladder, Neurogenic
D014552	Urinary Tract Infections