EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687748
• Other study ID #: Rec/00836 Asma Jamshed
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 30, 2021

Study information

• Verified date: June 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Pakistan	Rehab Center RCRAHS Potohar campus	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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