EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

NCT04687748 | Completed

• 1 other identifier: Rec/00836 Asma Jamshed
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Incontinence

Keywords

Pelvic floor muscles; Electromyographic Biofeedback; pelvic floor strengthening

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Kings health Questionnaire(KHQ)

  Baseline

• Kings health Questionnaire(KHQ)

  Post 8th weeks

Study Arms (2)

EMG BF Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Other: PFM exercises

Interventions

Electromographic Biofeedback 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.

EMG BF Group

PFM exercises 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Post partum females will be recruited in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rehab Center RCRAHS Potohar campus

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 32400762 BACKGROUND

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

  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.

  PMID: 32647538 BACKGROUND

• 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.

  PMID: 31790463 BACKGROUND

• 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.

  PMID: 26883864 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huma Riaz, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be selected through purposive sampling technique per inclusion \& exclusion criteria. Further, Randomization will be done by sealed envelope method.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 29, 2020
• Study Start: February 1, 2021
• Primary Completion: May 15, 2021
• Study Completion: May 30, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)