Trial Outcomes & Findings for Non-invasive Nerve Stimulation for Inhibition of Bladder Incontinence in Spinal Cord Injured Subjects. (NCT NCT03877432)
NCT ID: NCT03877432
Last Updated: 2021-01-20
Results Overview
Investigator will verify that S2-S4 dermatome nerve stimulation is acutely effective at reducing hyper-reflexic bladder activity during bladder filling in urodynamic measurement. All experimental trials will be completed in one day for each subject. Serial cystometrograms will be conducted by filling the bladder with saline and recording the volume in the bladder with or without concomitant nerve stimulation. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. Stimulation threshold will be randomly given (1-4 folds of stimulation threshold). Data from each of 4 stimulation fills per threshold or a total of 4 control fills were averaged. The averaged values are presented per Arm/Group below. The interval between every fill is 20-40 min. Investigator will compare the difference of bladder capacity (mL) between giving-control fill and fill with stimulation through statistical analysis.
UNKNOWN
NA
10 participants
The outcome measure will be assessed in day 1.
2021-01-20
Participant Flow
Participant milestones
| Measure |
Dermatome Stimulation
Check the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation.
Dermatome stimulation: Dermatome (S2-S4) stimulation is aimed at improving the function of bladder storage and bladder capacity. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. The minimum (or threshold) stimulation amplitude (T) necessary to elicit the genito-anal reflex was first determined for each subject. Subsequently, each subject received a randomized sequence of cystometric fill trials with and without continuous dermatome stimulation. The dermatome stimulation was randomly stimulated at stimulation amplitudes of 1, 2, 3, and 4 T.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-invasive Nerve Stimulation for Inhibition of Bladder Incontinence in Spinal Cord Injured Subjects.
Baseline characteristics by cohort
| Measure |
Dermatome Stimulation
n=10 Participants
Check the effect of improving the function of bladder storage and bladder capacity before and after dermatome stimulation.
Dermatome stimulation: Dermatome (S2-S4) stimulation is aimed at improving the function of bladder storage and bladder capacity. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. The minimum (or threshold) stimulation amplitude (T) necessary to elicit the genito-anal reflex was first determined for each subject. Subsequently, each subject received a randomized sequence of cystometric fill trials with and without continuous dermatome stimulation. The dermatome stimulation was randomly stimulated at stimulation amplitudes of 1, 2, 3, and 4 T.
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
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Age, Categorical
Between 18 and 65 years
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10 Participants
n=93 Participants
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Age, Categorical
>=65 years
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0 Participants
n=93 Participants
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Sex: Female, Male
Female
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0 Participants
n=93 Participants
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Sex: Female, Male
Male
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10 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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10 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=93 Participants
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Race (NIH/OMB)
White
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0 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
Taiwan
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10 participants
n=93 Participants
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PRIMARY outcome
Timeframe: The outcome measure will be assessed in day 1.Investigator will verify that S2-S4 dermatome nerve stimulation is acutely effective at reducing hyper-reflexic bladder activity during bladder filling in urodynamic measurement. All experimental trials will be completed in one day for each subject. Serial cystometrograms will be conducted by filling the bladder with saline and recording the volume in the bladder with or without concomitant nerve stimulation. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. Stimulation threshold will be randomly given (1-4 folds of stimulation threshold). Data from each of 4 stimulation fills per threshold or a total of 4 control fills were averaged. The averaged values are presented per Arm/Group below. The interval between every fill is 20-40 min. Investigator will compare the difference of bladder capacity (mL) between giving-control fill and fill with stimulation through statistical analysis.
Outcome measures
| Measure |
Control
n=8 Participants
Subjects first received a control fill without genital nerve stimulation (GNS) to determine their bladder capacity (baseline).
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1T (Threshold)
n=8 Participants
Subjects received 1 fold of stimulation threshold (1T) amplitude while cystometrogram performed.
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2T (Threshold)
n=8 Participants
Subjects received 2 folds of stimulation threshold (2T) amplitude while cystometrogram performed.
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3T (Threshold)
n=8 Participants
Subjects received 3 folds of stimulation threshold (3T) amplitude while cystometrogram performed.
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4T (Threshold)
n=4 Participants
Subjects received 4 folds of stimulation threshold (4T) amplitude while cystometrogram performed.
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The Changes of Bladder Capacity (mL) by Using Urodynamic Measurement
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253 ml
Standard Deviation 112
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346 ml
Standard Deviation 116
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332 ml
Standard Deviation 137
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390 ml
Standard Deviation 157
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401 ml
Standard Deviation 134
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SECONDARY outcome
Timeframe: The outcome measure will be assessed in day 1.Investigator will verify that S2-S4 dermatome nerve stimulation is acutely effective at reducing hyper-reflexic bladder activity during bladder filling in urodynamic measurement. All experimental trials will be completed in one day for each subject. Serial cystometrograms will be conducted by filling the bladder with saline and recording the pressure in the bladder with or without concomitant nerve stimulation. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. Stimulation threshold will be randomly given (1-4 folds of stimulation threshold). The interval between every fill is 20-40 min. Investigator will compare the difference of bladder capacity (mL) between giving-control fill and fill with stimulation through statistical analysis.
Outcome measures
Outcome data not reported
Adverse Events
Dermatome Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place