Integrated Effect of Non-Invasive Neuromodulation and Genital Nerve Stimulation on bladder function in Traumatic Spinal Cord Injury Patients

Need of the Study

Bladder incontinence has a huge impact on individual’s quality of life with significant change in behaviour both socially and psychologically. There is high rate of morbidity and mortality rate due to deterioration in lower urinary tract. Maintaining good hygiene of the bladder is the biggest problem associated with the management of bladder dysfunction following SCI. The mismanaged bladder led to overdistended bladder, larger volume of urine output, resulting in the leakage of urine which is harmful to the bladder and the kidneys. SCI survivors depend on others for their basic Activity of daily living (ADL), which create worse impact on their personality in every domain of life.

Bladder rehabilitation is overlooked in developing countries due to a circular sequence of events like fear, embarrassment in discussing the problem. A loss of self-esteem and confidence, personal and social isolation, psychologic symptoms such as depression, apathy and anger contribute for not giving preference to bladder rehabilitation.

In the present arena, treatment scenario has been modified significantly for bladder rehabilitation and also bladder rehabilitation is given foremost importance in neuro-rehabilitation set-ups. The conventional methods of treatment including medication, invasive stimulation, nerve blocks work symptomatically but they are not efficient in restoring the bladder function permanently. Various non-invasive techniques are used in clinical set ups to improve bladder function, but they are less effective and not for prolonged use. Various Stimulation technique are difficult to tolerate for every individual due to high intensity current application (Gad *et al.,*2015), not cost effective, immediate results are not obtained and not feasible for every clinical set up.

Hence, there is strong need to adopt the methods to restore the bladder function which are endurable, easy to administer, non-invasive and will be cost effective. Non–invasive Neuromodulation is a real and growing healthcare application driven by advances in neuroscience capabilities.  Restoration of bladder function via non-invasive neuromodulation is a topic of current interest of research.

Hence, the present study attempts to determine the integrated effect of non- invasive neuromodulation and genital nerve stimulation on bladder function in traumatic SCI patients.

Aim of the Study

To determine the integrated effect of Non-Invasive Neuromodulation through repetitive Trans-Magnetic Stimulation (rTMS) with Genital Nerve Stimulation in traumatic Spinal Cord Injury patients with special reference to Urinary Bladder Function.

Objectives of the Study

To determine the effect of Genital Nerve Stimulation alone and in combination with non-invasive neuromodulation through Repetitive Trans-Magnetic stimulation, rTMS on urinary bladder function in Individuals following traumatic SCI.

1.     1. On sensory-motor improvement through ASIA impairment score.

2.     2. On the Genito-anal reflex and to monitor pelvic floor activity via EMG-MEP (Electromyography).

3.     3. On bladder function i.e. retention, voiding and bladder contraction through Urodynamics: uroflowmetry, pressure flow study, urethral pressure profile, cystometry, post void residual volume

4.     4. On functional activity through Spinal Cord Independence Measure Scale-III (SCIM-III).

Methodology

Nature of the Study

The present study will be a prospective randomized controlled clinical trial.  Participants will be selected based on the sample selection criteria and will be randomly allocated into two groups i.e. (Experimental Group A), (Experimental Group B).

Consent and Ethical Considerations

Ethical approval for the present study has been taken from the Institutional Ethical Committee, Punjabi University, and Patiala. Written consent will be taken from all the participants, willing to participate, prior to the commencement of the study.

Study Population

SCI survivors with the age Group (20-50 years) will constitute the Population of the study. The participants will be selected from Various Physiotherapy/rehabilitation Centres/Hospitals in and around Punjab.

Sampling Method

The computer-generated random sampling method will be used to allocate the participants in control and experimental group. The randomisation schedule for all participants will established prior to recruitment by the researcher using a computer-generated random list (https://www.graphpad.com/quickcalcs/randomize2/).

Study settings

·       OPD of Department of physiotherapy, Punjabi university, Patiala, Punjab.

·       Neuroots Clinic, Patiala. Punjab.

·       Indian Spinal Injury Centre, Vasant Kunj New Delhi.

Sample Size

G Power software was used for sample size calculation (Erdfelder, 2009; Erdfelder, 2007). The calculated sample size for the study is 40. Given reasonable attrition rate of 5%, the final sample size calculation, was done using formula.

N 1 = Total Sample size, N=Calculated Sample size, q= Proportion of attrition

N 1 (The final sample size calculated to be 50, with (n=25) in each group.

Protocol

Participants having SCI will be selected as per selection criteria

Written consent will be obtained from the participants prior to the commencement of the study

Baseline Assessment will be done for the outcome measures of the study ASIA score, Electromyography, urodynamics, SCIM-III

Participants will be randomly allocated into 2 groups (N=50)

Group A (Experimental Group) (n = 25) rTMS+Genital Nerve Stimulation + Conventional Physiotherapy 5 session weekly, for 4 weeks

Group B (Control Group) (n = 25) Sham rTMS + Genital Nerve Stimulation + Conventional Physiotherapy 5 session weekly, for 4 weeks

Post Intervention assessment will done at Day 15 and Day 30 for outcome measures of the study ASIA Score, EMG, urodynamics, SCIM-III.

Data will be collected

Statistical analysis of the data will be done using SPSS Version 16.0