SUMMARY
TITLE: COMPARING THE EFFECTIVENESS OF POSTERIOR TIBIAL NERVE
STIMULATION AND DORSAL GENITAL NERVE STIMULATION ON NEUROGENIC DETRUSOR
OVERACTIVITY IN INDIVIDUALS WITH SPINAL CORD INJURY.
BACKGROUND
Neurogenic
detrusor overactivity (NDO) is one of the most important sequelae after spinal
cord injury (SCI) and may predisposes to bothersome urinary incontinence, high
risk of infection and impairment of personal hygiene, difficulty in sexual
activity and if left untreated may lead to back pressure changes of upper tract
and impairment of renal function.
Standard
interventions, including cauterization strategies, medications, behavioral
controls, and surgery, have been used to treat NDO. However, NDO is often
refractory to behavioral and physical therapies.
Posterior
tibial nerve stimulation (PTNS) and Dorsal genital nerve stimulation (DGNS) are
two non-invasive neuromodulation treatments that have shown promising results
in managing NDO. Tibial nerve stimulation propagates electrical currents to
modulate the spinal detrusor reflex arc and inhibits detrusor muscle activity
to decrease incontinence.
Dorsal
genital nerve stimulation (GNS) is a promising treatment for NDO because the
neuromodulation mechanism mainly involves the regional spinal reflex pathways
in the lower urinary tract.
OBJECTIVES
1. To evaluate the effects of Posterior
Tibial nerve stimulation versus Dorsal Genital nerve stimulation on bladder
function assessed by urodynamic study in individuals with spinal cord injury.
1A. Bladder incontinence assessed by
neurogenic bladder symptom score.
1B. Quality of life assessed by
Incontinence- quality of life.
HYPOTHESIS:
NULL HYPOTHESIS-
HN1: There will be no significant
difference in effectiveness of Posterior tibial nerve stimulation and Dorsal
Genital Nerve stimulation on bladder function assessed by urodynamic study in
individual with Spinal cord injury
HN1A: Bladder
incontinence assessed by neurogenic bladder symptom score.
HN31B: Quality of life assessed by
Incontinence–quality of life questionnaire.
ALTERNATE HYPOTHESIS-
HA1: There will be significant difference
in effectiveness of Posterior tibial nerve stimulation and Dorsal Genital Nerve
stimulation on bladder function assessed by urodynamic study in individual with
Spinal cord injury.
HA1A: Bladder incontinence assessed by
neurogenic bladder symptom score.
HA1B: Quality of life assessed by
Incontinence–quality of life questionnaire.
MATERIALS AND METHODS
STUDY DESIGN: Experimental study
design
SAMPLE SIZE:
30 (15 in each group)
(Outcome measure used is I-QOL)
ENROLMENT
PERIOD: 6-7 months after RRC and IEC
clearance
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INCLUSION CRITERIA
- Age- 18 – 55
years
- Both male & female
- Patients with a history of spinal cord injury
for more than 3 months, presenting with baseline NDO on urodynamic
studies
- Traumatic SCI
- Lesion: Complete/Incomplete
- Asia Impairment Scale – A,B,C,D
- Supra
L1 lesion and above.
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EXCLUSION CRITERIA
- Individuals in spinal shock phase.
- Subjects using Botox for NDO in past one year.
- Individuals with active urinary tract infection
at time of study.
- Individuals with other neurological conditions
leading to NDO.
- Individuals having psychosomatic illness/
disease.
- Un-cooperative Individuals.
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TOTAL STUDY
DURATION: 4 weeks intervention duration.
STUDY
PROCEDURES: Patients will be screened based on
inclusion and exclusion criteria. They will be enrolled into 2 groups with the
help of random allocation software. (Experimental Group 1) will receive Posterior
Tibial Nerve Stimulation for 5 times a week for 4 weeks. (Experimental Group 2)
will receive Dorsal Genital Nerve Stimulation for the same duration.
OUTCOME
MEASURE: Pre- and post-intervention tests will be carried out using-
1. Incontinence-Quality of life
2. Urodynamic Study
3. Neurogenic Bladder Symptom
Score
STATISTICAL ANALYSIS PLAN (SAP):
·
Descriptive statistics will
calculate the mean and standard deviation for quantitative variables (e.g. age)
and frequencies for categorical variables (e.g., gender, NBS).
·
The Shapiro-Wilk test will assess
normality.
·
If the data is normally distributed,
an independent t-test will evaluate differences between the groups.
·
Paired t-test will be used to
evaluate average difference within the group for normal data.
·
For skewed data, the Wilcoxon
signed-rank test will assess within-group changes, and the Mann-Whitney U test will
compare between-group differences.
·
Data will be analysed using SPSS
21with Excel for data management.
·
Statistical significance will be set
at a 5% alpha level. |