Electrostimulation of Pelvic floor muscle in a female with Stress and stress predominant mixed Urinary Incontinence – A Randomised controlled trial

Title- Electrostimulation of Pelvic floor muscle in a female with Stress and stress predominant mixed  Urinary Incontinence

 Introduction

Prevalence estimates of SUI range from 3% to 25% of adult women, with older women more likely to be affected (1). Quality of life and sexual function are  substantially impaired by the fear of leakage, resulting in avoidance of social or physical activities which might cause it, embarrassment and poor sleep (2). SUI can severely impact the ability to carry out daily activities, resulting in debilitating embarrassment, social isolation and considerably decreased health-related quality of life (3). Women with SUI may be less likely to participate in physical activity, which in turn has a detrimental impact on overall health because inactivity is a risk factor for many diseases (4). Electrical stimulation (ES) has emerged as a first-line alternative to PFMT in women who are unable to contract their pelvic floor muscles voluntarily or as a second-line treatment if PFMT alone is not sufficiently effective. It may also be beneficial to combine ES with the PFMT and drug therapy.

 Aim of Study:

To determine the effectiveness of electrical stimulation in combination with other treatment like Pelvic floor muscle therapy(PFMT),Drugs (Anticholinergic and beta 3 agonist) in women with Stress and stress predominant mixed  Urinary Incontinence

 Materials And Methods:  Randomised control trial

 Diagnosis of Stress Urinary Incontinence and Stress Predominant Mixed Urinary Incontinence  will be based on  Clinical history,3 days Bladder diary, ICIQ-UI-SF ,Local examination (Cough stress test),Baseline Pad test

 Patient will be randomised by method of permuted block randomisation

  Randomisation is be  done by Physiotherapist at their department to conceal allotement, who is not the part of study,

  Participants will be  allocated to the combined intervention group (n = 30) , They will be receiving self-exercises of the pelvic floor muscles(PFMT) 3 times a day per weekly  along with Drugs (Anticholinergic and beta 3 agonist), and the Electro Stimulation of pelvic floor muscle (20 min session on 3-5 days per week for at least 6 week).

Participants in the comparison group (n = 30) will be receiving  the PFMT along with Drugs(Anticholinergic and beta 3 agonist)

Muscle stimulator machine  will be delivering  Surge faradic(SF)  Intermittent direct current with -

i.     Frequency  50-100 HZ

ii.     Itensity  0-7 mA with 7 sec stimulation and 3 sec  relaxation time

iii.     Transcutaneous electrode will be placed on the labia majora or bulbocavernous muscle and Perianal region and  on suprapubic skin surface

 Intervention  Group 1( n-30)- PFMT with Electro stimulation with Drugs

Comparison Group 2(n-30) – PFMT with Drug

       Outcome measurement will be assessed by Subjective satisfaction (Clinically no leak Assess by  Bladder diary , ICIQ-UI-SF) ,Bladder diary for 3 days,Pad test (before and  after treatment) ,and improvement of stress cough test

Study outcomes will be measure at baseline and at the end of the 6-week period of combined therapy

 Inclusion Criteria:

 Female  Patients presenting with clinically diagnosed Stress and stress predominant mixed  Urinary Incontinence

Exclusion criteria:

Urgency urinary incontinence alone

A prolapse greater than stage II on examination (>1cm below the hymen on straining)

Pregnant or had given birth in the past six months

Who were receiving treatment for pelvic cancer

Neurogenic bladder

 Statistical Analysis:

Statistical Analysis will be done using SPSS V.26(IBM SPSS Inc) software. Categorical variables will be compared using Chi-squared test and continuous variables were using T-test respectively. P valve <0.05 will be consider statistically significant

 Outcome:

Ø Outcome measurement will be assessed by Subjective satisfaction (Clinically no leak Assess by  Bladder diary ,  International Consultation on Incontinence Modular Questionnaire–Short Form for Urinary Incontinence  (ICIQ-UI-SF) ,Bladder diary for 3 days,Pad test (before and  after treatment) ,and improvement of stress cough test

Ø Study outcomes will be measured at baseline and at the end of the 6-week period of combined therapy

1)Primary outcome: Cure: number of women with self-reported continence (no urinary incontinence, as reported by women)

2)Secondary outcomes:

Satisfaction with treatment

Quantification of symptoms (e.g. number of incontinence episodes (every 24 hours), number of micturitions every 24 hours will be assessed by 3 days bladder diary, ICIQ-UI-SF, Pad tests,stress cough test )