Effect of pelvic floor muscle training and TENS along with activity based training to improve neurogenic bladder bowel and sexual dysfunction in Spinal cord injury patient-A Randomized controlled trial

6.1 INTRODUCTION:

A spinal cord injury is damage to the spinal cord that causes changes in its function which may be permanent or temporary in the loss of muscle function, sensations, autonomic functions at various parts of the body below the level of lesion [1]. Although nontraumatic reasons including infection, inadequate blood flow, and tumors can also cause damage, physical trauma from incidents like auto accidents, gunshot wounds, falls, or sports injuries accounts for the majority of cases. About 50% of injuries are to the cervical spine, and 15% are to the thoracic, lumbar, and borderline thoracic spine [2].

Every year, between 250,000 and 500,000 people worldwide sustain spinal cord injuries. The majority of these cases are the result of avoidable factors like car crashes and violence. Most individuals with SCI associated with sports injuries are men. The 16–30 age range is the one with the highest risk of SCI [3].

Whether or not the spinal cord is severed, a "complete" spinal injury results in the loss of all functions below the injured location. In a "incomplete" spinal cord injury, motor or sensory function is preserved below the level of injury.. Damage to the somatic and autonomic pathways can also lead to neurogenic lower urinary tract, sexual, and bowel dysfunction, pressure sores, neurogenic heterotopic ossification, neuropathic pain, dysphagia, dysphonia, and altered cardiorespiratory function.[4]. In the regions innervated by S4 to S5, such as the voluntary contraction of the external anal sphincter, there must be some preservation of sensation or motion in order for the condition to be deemed incomplete. [5] By definition, incomplete injury includes a condition called sacral sparing, in which some degree of sensibility is retained in the sacral dermatomes, notwithstanding the possibility that sensitivity in other, higher dermatomes beneath the lesion level may be more severely compromised. [6]

In addition to paralysis, people with spinal cord injury (SCI) also suffer from a variety of less obvious but equally incapacitating autonomic dysfunctions. [7,8] Restoring autonomic functions, particularly those related to the lower urinary tract (LUT), bowel, and sexual function, is considered one of the most important aspects of healing for people with spinal cord injuries [9,10]. When these pelvic organs produce impulses that cause extreme hypertension episodes of autonomic dysreflexia, impairments in sexual, LUT, and bowel functions might have potentially fatal cardiovascular effects [11].

The management of neurogenic bladder and bowel (NBB) is one of the most crucial aspects of spinal cord injury/disease (SCI/D) therapy. Similarly, the second most frequent problem that SCI patients describe, and the fourth most frequent reason for re-hospitalization, is gastrointestinal dysfunction.[12]

The coordinated action of smooth and striated muscles, which maintain the regular alternation of storage (urinary bladder) and emptying (bladder neck, urethra, and urethral sphincter), phases, is essential to the lower urinary tract’s function [13]. A complex neurological regulation that is dispersed across peripheral channels central pathways (brain and spinal cord) is responsible for mediating the coordination of this function [13,14]. The most reliable method for evaluating detrusor and bladder outlet function, as well as detrusor pressure and compliance, is urodynamics [15].

After SCI, sexual function is frequently and significantly impacted. The complex interaction of bio-psycho-social factors leads to this impairment.50% of women and 29% of men report having less desire for sexual activity; 70–81% of men have erectile dysfunction; 50–80% of women report having less arousal or dry vagina; nearly all male patients report having less or no ejaculation; and 75–89% report having orgasmic dysfunction [16]. Due to changes in ejaculation and semen, male patients with impaired sexual functions may have lower fertility. Female patients with SCI can still become pregnant, however they may experience particular difficulties, such as autonomic dysreflexia [17].

Neurogenic bowel dysfunction follows traumatic brain injury (SCI) and is brought on by a lack of control over autonomic and somatic pathways. Constipation, fecal incontinence, or a mix of the two symptoms are possible for patients. Abdominal pain, rectal bleeding, rectal prolapse, anal fissure, bloating, nausea, autonomic dysreflexia, prolonged evacuation, impaction, and intestinal obstruction are just a few consequences that patients with this condition may experience [18]. Patients with complete lesions show a slower colonic transit time than those with incomplete injuries, resulting in a more severe clinical presentation; overall, 42% of patients report severe bowel symptoms [18,19]. According to reports, the evacuation process takes more than 30 minutes for 22% and 14% of adult patients with acquired SCI, respectively. Additionally, 23% of patients are totally reliant, and 12% of patients need assistance with evacuation [20].

A proven first-line conservative treatment for Urinary incontinence  is pelvic floor muscle training (PFMT), which is five times more likely to result in a symptomatic cure than either no treatment or passive control measures [21]. Numerous studies have shown that PFMT is safe and efficient in treating bladder dysfunction and enhancing quality of life. Through coordinated contractions between the transversus abdominis and the pelvic floor muscles, PFMT improves bladder function by raising urethral pressure, supporting the neck of the bladder, and interacting with the transversus abdominis. The actual regimen of PFMT in clinical settings varies greatly, despite the fact that many guidelines urge it. The data is not strong enough to support a PFMT regimen that is standardized [21].

Urinary symptoms and sexual dysfuntion can be treated by a type of neuromodulation called tibial nerve stimulation (TNS), which uses electrical impulses. The purpose of neuromodulation is to target the innervation system of the lower urinary tract. The sciatic nerve has a distal branch called the posterior tibial nerve, which starts in the pelvis (L5–S3 spinal roots) and travels down to the lower extremities. The sacral nerve plexus, which regulates the function of the bladder, receives retrograde neuromodulation from stimulation of the posterior tibial nerve.[22]. Neuromodulation via the tibial nerve, which offers a convenient entry point and is located in the same metameric area as the pelvic floor’s somatic and parasympathetic innervation (S2—S4)  [23]. Both SNM24–27 and PTNS28–30 therapies were found to significantly improve sexual functioning as measured by the Female Sexual Function Index (FSFI) in clinical trials where patients receiving neuromodulation treatment for bladder dysfunction. While it is well known that bladder dysfunction negatively affects sexual function changes in sexual functioning have been reported to occur independently of improvements in bladder functioning suggesting that genital arousal may be directly impacted by neuromodulation [24]. No studies have evaluated the effects of pelvic floor strengthening and  peripheral nerve stimulation specifically on patients with spinal cord injury Hence there are very few literature available on conservative management of neurogenic bladder, bowel and sexual dysfunction in spinal cord injury patient.

The goal of this study is to find the effect of pelvic floor muscle training and TENS along with activity based training to improve neurogenic bowel, bladder and sexual dysfunction in Spinal cord injury patient.

Need for the study:

A spinal cord injury causes changes in its function which may be permanent or temporary in the loss of muscle function, sensations, autonomic functions at various parts of the body below the level of lesion. Current literature has shown that Neurogenic Bowel, Bladder and sexual dysfunction is one of the most common problems in spinal cord injury. There are very few literature available on conservative management of neurogenic bowel, bladder and sexual dysfunction in Spinal cord injury patient. Pelvic floor muscle training gives better effect in Spinal cord injury patient, but there is paucity of literature to check effect of pelvic floor muscle training along with TENS in Spinal cord injury patient. Hence the need of my study is effect of pelvic floor muscle training and TENS along with activity based training to improve neurogenic bowel, bladder and sexual dysfunction in Spinal cord injury patient.

 Research Question:

Will there any  effect of pelvic floor muscle training and TENS along with activity based training to improve neurogenic bowel, bladder and sexual dysfunction in Spinal cord injury patient?

6.2 Aim and Objectives of the study:

Aim:

AIM:

To find the effect of pelvic floor muscle training and TENS along with activity based training to improve neurogenic bowel, bladder and sexual dysfunction in Spinal cord injury patient.

Objective:

1.To find out the effect of Pelvic floor muscle training and  TENS along with activity based training on Neurogenic Bladder by Neurogenic Bladder symptom scale, Urinary Diary and Reflex Examination

2. To find out the effect of Pelvic floor muscle training and TENS along with activity based training on Neurogenic bowel by Neurogenic Bowel Dysfunction Score, Anorectal Examination and Reflex Examination

3. To find out the effect of Pelvic floor muscle training and TENS  along with activity based training on Sexual Dysfunction by International Index of Erectile Function, Female Sexual Function Index

  Hypotheses:

Null Hypothesis (H0):

There will be no significant effect of pelvic floor muscle training and TENS along with activity based training to improve neurogenic bowel, bladder and sexual dysfunction in Spinal cord injury patient

Alternative Hypothesis (H1):

There will be significant effect of pelvic floor muscle training and TENS along with activity based training to improve neurogenic bowel, bladder and sexual dysfunction in Spinal cord injury patient

MATERIAL AND METHODOLOGY:

Source of Data:  Pravara Rural Hospital, Loni

Study setting:  The study will be conducted at department Neuro-physiotherapy  Physiotherapy, Dr .A.P.J Abdul Kalam college of physiotherapy, Loni.

Study Duration: 2 years

Method of collection of data: One on One interview

Type of Data: Quantitative data

Study Design:  Randomized controlled trial

Intervention

Group ‘A’ (Activity Based Training)

Type and duration of treatment

EXERCISE DURATION

EXERCISE PROTOCOL

|Activity Based Training

(0-4week)

Frequency:-5 days per week (5 Rep X 2 Set of each exercise)

Time:- 45min

Type:- Activity Based

Training

       1) Warm up exercise

1)Stretching for all the muscle

2. neck movement

2) Exercise Protocol

1)Mat activities

Lateral Obliques,

Abdominal Curl Ups,

Supine Heel Touch,

Pelvic Bridging

2)Bed side sitting

Trunk Rotation

Trunk forward bending

3)Gait Training in parallel bar

4)Stair Climbing

Cool Down Exercise

1)Breathing exercise

GROUP ‘B’ (Pelvic floor muscle training + TENS + Activity Based Training)

 

Type and duration of treatment

EXERCISE DURATION

EXERCISE PROTOCOL

| (0-4 week)

  Frequency:-5 days per week (5 Rep X 2 Set of each exercise)

Intensity:-Low to moderate intensity of 10 sec hold

Time:-30 min

Type:- Pelvic floor muscle training

    Frequency:- 5 days per week of  10 Hz.

Intensity:- Low intensity

0–100 mA

Pulse width:- 200 µs

Time:- 15 min

Type:-Conventional TENS

1. Kegal Exercise

2)Squeeze and release

3)Pelvic Bridging

4)Pelvic tilt

5)Diaphragmatic Breathing

6)Transverse Abdominis Activation

7)Static adductor

8)Hypopressive exercise in lying, sitting, Kneeling

   Tibial Nerve Stimulation

Progression Phase:-

In progression stage we are going to increase repetition and hold by 10 sec and at the end of 4th week patient should  able to hold for 30 sec with 5 repetition and 3 sets

Sample size: 36

Sampling Method: Simple random sampling

Study Duration: 2 years

Material to be used:

1. Consent form

2. Assessment sheet

3. ASIA

4.Reflex Hammer

5. Pin

6.Cotton

7.Pen

SELECTION CRITERIA:

Inclusion criteria:

Participants included will be:

1. 20- 65 year of age

2. Both male and female

3. Traumatic and non-traumatic  incomplete Spinal cord injury

4. Documented presence of bowel and bladder dysfunction

5. Documented presence of sexual dysfunction

6. Able to understand and complete study related questionnaire and exercise

7. Medication dosage must be stable for period of 4 weeks

9. Willing to undergo investigations.

9. Participants who willing to participate

E****xclusion criteria:

Participants excluded will be:

1. Current Urinary tract infection.

2. Pain from urinary tract

3. Patient with complete spinal cord injury.

4. Patient with bed sores.

5. Patient with medication change recently.

6. Implanted metal under electrode application site.

7. Patient who are currently participating in another research.

8. Patient who have cognitive problem.

9. Women with active pregnancy.

**10.**Any metabolic disorder.

11. Patient who not willing to participate in study.

Outcome Measures:

Outcome measures used for this study will be as follows,

Primary Outcome:-

Neurogenic Bladder symptom scale (r:- 0.91)

Neurogenic Bowel Dysfunction Score (r:-0.9)

International Index of Erectile Function (r:-0.95)

Female Sexual Function Index (r:-0.94)

Secondary Outcome

Urinary Diary

Reflex Examination

ASIA

 

Variables

Measurement Method

Statistical

Scales

Descriptive Statistics

|Age

Interview

Scale

Mean ± SD Proportion

|Gender

Observation/

Interview

Nominal Scale

Mean ± SD Proportion

|ASIA

Assessment

Nominal

Mean ± SD Proportion

|Neurogenic Bladder improvement

Neurogenic Bladder symptom scale

Urinary Diary

Reflex Examination

Ratio Scale

Mean ± SD Proportion

|Neurogenic Bowel improvement

Neurogenic Bowel Dysfunction Score, Anorectal Examination,

Reflex Examination

Ratio Scale

Mean ± SD Proportion

|Sexual Dysfunction

International Index of Erectile Function, Female Sexual Function Index

Ratio Scale

Mean ± SD Proportion

Procedure

Protocol is prepared and ethical clearance will be obtained from the IEC.

The Participants will be selected based on the eligibility criteria.

Informed consent will be obtained from the participants and demographic data will be  recorded.

Participants will be randomly allocated to 2 groups that is experimental group(n=) and control group(n=). Prior assessment of the participants will be done.

Experimental group will be administered with Pelvic floor muscle training along with TENS and conventional physiotherapy and control group will be administered with conventional treatment for neurogenic bowel bladder and sexual dysfunction in spinal cord injury.

All the instructions will be given verbally, provided demonstration and guided through a single practice trial of SFE.

 Sampling method

Then simple random sampling will be done for distribution of (Number of participants) into 2 groups. (Group A Activity Based Training) and (Group B Pelvic floor muscle training along with TENS +Activity Based Training). Target population were > 20 years of age of participants will be taken from PRH, Loni. Subjects with presence of neurogenic bowel, bladder and sexual dysfunction in spinal cord injury, ASIA B (Incomplete SCI) , ability to understand and follow instructions, who were willing to participate, included in the study.

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