Comparing the effectiveness of Posterior Tibial Nerve Stimulation and Dorsal Genital Nerve Stimulation on Neurogenic Detrusor Overactivity in Individuals with Spinal Cord Injury.

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

INCLUSION CRITERIA

 

1. Age- 18 – 55 years
2. Both male & female
3. Patients with a history of spinal cord injury for more than 3 months, presenting with baseline NDO on urodynamic studies
4. Traumatic SCI
5. Lesion: Complete/Incomplete
6. Asia Impairment Scale – A,B,C,D
7. Supra L1 lesion and above. EXCLUSION CRITERIA

 

1. Individuals in spinal shock phase.
2. Subjects using Botox for NDO in past one year.
3. Individuals with active urinary tract infection at time of study.
4. Individuals with other neurological conditions leading to NDO.
5. Individuals having psychosomatic illness/ disease.
6. Un-cooperative Individuals.

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.