EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: Electromographic Biofeedback; Other: PFM exercises

• Registration Number: NCT04687748
• Lead Sponsor: Riphah International University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-25
• Study First Submitted QC: 2020-12-25
• Study First Posted: 2020-12-29
• Study Start: 2021-02-01
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-11
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Post-partum females
• Persistent urinary leakage at 3 months post-partum period
• Urine leakage with coughing, sneezing or exercise

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Exclusion Criteria

• Neurogenic bladder
• History of pelvic surgeries, pelvic tumors, UTI, urge incontinence, uncontrolled diabetes, cerebral stroke, previous injuries within pelvic

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMG BF Group	Electromographic Biofeedback	Pelvic floor muscle contraction will be performed via an S-EMGBF device; patients in the s-EMGBF group will receive visual and auditory feedback.
Control Group	PFM exercises	Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds.

Primary Outcome Measures

Name	Time	Method
Pelvic floor muscle(PFM) Strength	Post 8th weeks	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)
Pelvic distress inventory Questionnaire-20	post 8th week	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.

Secondary Outcome Measures

Name	Time	Method
Kings health Questionnaire(KHQ)	Post 8th weeks	Quality of life of patients will be measured by KHQ. It is a 10 items questionairre with rating on 4 item likert scale

Trial Locations

Locations (1)

Rehab Center RCRAHS Potohar campus; 🇵🇰 Rawalpindi, Punjab, Pakistan