EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

NCT ID: NCT04687748

Last Updated: 2021-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-05-30

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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be selected through purposive sampling technique per inclusion \& exclusion criteria. Further, Randomization will be done by sealed envelope method.

Study Groups

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EMG BF Group

Pelvic floor muscle contraction will be performed via an S-EMGBF device; patients in the s-EMGBF group will receive visual and auditory feedback.

Group Type EXPERIMENTAL

Electromographic Biofeedback

Intervention Type DEVICE

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.

Control Group

Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds.

Group Type ACTIVE_COMPARATOR

PFM exercises

Intervention Type OTHER

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.

Interventions

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Electromographic Biofeedback

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.

Intervention Type DEVICE

PFM exercises

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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huma Riaz, PHD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Rehab Center RCRAHS Potohar campus

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Nawaz H, Arshad H, Asim HM. Stress urinary incontinence after child birth - An unreported complication. J Pak Med Assoc. 2020 May;70(5):944. doi: 10.5455/JPMA.50445. No abstract available.

Reference Type BACKGROUND
PMID: 32400762 (View on PubMed)

Anwer S QNMMEA. Effectiveness of electromyographic biofeedback training on quadriceps muscle strength in osteoarthritis of knee. 2011; 29(2)

Reference Type BACKGROUND

Kopanska M, Torices S, Czech J, Koziara W, Toborek M, Dobrek L. Urinary incontinence in women: biofeedback as an innovative treatment method. Ther Adv Urol. 2020 Jun 25;12:1756287220934359. doi: 10.1177/1756287220934359. eCollection 2020 Jan-Dec.

Reference Type BACKGROUND
PMID: 32647538 (View on PubMed)

Chmielewska D, Stania M, Kucab-Klich K, Blaszczak E, Kwasna K, Smykla A, Hudziak D, Dolibog P. Electromyographic characteristics of pelvic floor muscles in women with stress urinary incontinence following sEMG-assisted biofeedback training and Pilates exercises. PLoS One. 2019 Dec 2;14(12):e0225647. doi: 10.1371/journal.pone.0225647. eCollection 2019.

Reference Type BACKGROUND
PMID: 31790463 (View on PubMed)

Moroni RM, Magnani PS, Haddad JM, Castro Rde A, Brito LG. Conservative Treatment of Stress Urinary Incontinence: A Systematic Review with Meta-analysis of Randomized Controlled Trials. Rev Bras Ginecol Obstet. 2016 Feb;38(2):97-111. doi: 10.1055/s-0035-1571252. Epub 2016 Jan 29.

Reference Type BACKGROUND
PMID: 26883864 (View on PubMed)

Other Identifiers

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Rec/00836 Asma Jamshed

Identifier Type: -

Identifier Source: org_study_id

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