EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

Study Overview
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Brief Summary
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This study intends to determine the effects of Electromyographic biofeedback on performance of pelvic floor muscles in urinary incontinence.

Detailed Description
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This is a single blinded randomized controlled trial ,will be conducted at Ripha Rehab Clinic,Rawalpindi. (EMG) biofeddback is a adjunct therapy to standard exercise regime for increasing muscle strength,this study is planned to determine the effects of electromyographic biofeedback on performance of pelvic floor muscles, strength,endurance ,rate of biofeedback and its impact on the qulatiy of life (QOL).The sample size was calculated to be n=28 through open-epitool version 3 ,with 95%confidence interval (CI),and power 80%. After completion of therapeutic protocols, the participant will be assessed with the help EMG-biofeedback, Pelvic Floor distress inventory, King's Health Questionnaire.

Official Title
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Effects of Surface EMG-biofeedback on Pelvic Floor Muscle Training Among Women With Post-partum Urinary Incontinence.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Electromographic Biofeedback
* Other: PFM exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-partum females Persistent urinary leakage at 3 months post-partum period Urine leakage with coughing, sneezing or exercise Exclusion Criteria: Neurogenic bladder History of pelvic surgeries, pelvic tumors, UTI, urge incontinence, uncontrolled diabetes, cerebral stroke, previous injuries within pelvic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two groups of participants, Experimental group will receive pelvic floor strengthening with EMGBF (Electromyographic Biofeedback ) and control group receive excercises without EMGBF.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMG BF Group<br>Pelvic floor muscle contraction will be performed via an S-EMGBF device; patients in the s-EMGBF group will receive visual and auditory feedback. | Device: Electromographic Biofeedback<br>* Surface EMG biofeedback is an adjunct therapy to standard exercise regime for increasing muscle strength. Electromyographic biofeedback is a specific form of biofeedback. The device records muscle activity through application of vaginal probe will be inserted in vagina and the reference surface electrode would be placed over the right anterior superior iliac spine.<br>|
| Active Comparator: Control Group<br>Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds. | Other: PFM exercises<br>* Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds. Three attempts would be made with 40 seconds rest in between each contraction. The exercises would be performed with the patient initially in supine position, with hip and knee flexed at 30 and 90 degrees.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor muscle(PFM) Strength | To quantify PFM strength, the evaluator will insert the first two phalanges of the second and third fingers smeared in lubricant gel with a gloved hand into the anterior third of the vaginal opening and requested a maximal voluntary contraction by giving the command squeeze my fingers. Muscle strength will be classified according to the modified Oxford scale into: 0 (nil), 1 (flicker), 2 (weak), 3 (moderate), 4 (good) to 5 (strong) | Baseline | 
| Pelvic floor muscle(PFM) Strength | To quantify PFM strength, the evaluator will insert the first two phalanges of the second and third fingers smeared in lubricant gel with a gloved hand into the anterior third of the vaginal opening and requested a maximal voluntary contraction by giving the command squeeze my fingers. Muscle strength will be classified according to the modified Oxford scale into: 0 (nil), 1 (flicker), 2 (weak), 3 (moderate), 4 (good) to 5 (strong) | Post 8th weeks | 
| Pelvic distress inventory Questionnaire-20 | The PFDI-20 is comprised of 3 scales, which include the Urinary Distress Inventory-6 (UDI-6), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), and the Colorectal-Anal Distress Inventory. The total score is out of 20. | Baseline | 
| Pelvic distress inventory Questionnaire-20 | The PFDI-20 is comprised of 3 scales, which include the Urinary Distress Inventory-6 (UDI-6), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), and the Colorectal-Anal Distress Inventory. The total score is out of 20. | post 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kings health Questionnaire(KHQ) | Quality of life of patients will be measured by KHQ. It is a 10 items questionairre with rating on 4 item likert scale | Baseline | 
| Kings health Questionnaire(KHQ) | Quality of life of patients will be measured by KHQ. It is a 10 items questionairre with rating on 4 item likert scale | Post 8th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic floor muscles, Electromyographic Biofeedback, pelvic floor strengthening