Clinical trial NCT04687748: EMG Biofeedback Based Pelvic Floor Training in Post Partum Women
Official title: Effects of Surface EMG-biofeedback on Pelvic Floor Muscle Training Among Women With Post-partum Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Pelvic floor muscles
Electromyographic Biofeedback
pelvic floor strengthening
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pelvic floor muscle(PFM) Strength
timeFrame: Baseline
measure: Pelvic floor muscle(PFM) Strength
timeFrame: Post 8th weeks
measure: Pelvic distress inventory Questionnaire-20
timeFrame: Baseline
measure: Pelvic distress inventory Questionnaire-20
timeFrame: post 8th week
Secondary outcomes:
measure: Kings health Questionnaire(KHQ)
timeFrame: Baseline
measure: Kings health Questionnaire(KHQ)
timeFrame: Post 8th weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rehab Center RCRAHS Potohar campus
state: Punjab
Study officials:
affiliation: Riphah International University
name: Huma Riaz, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: Anwer S QNMMEA. Effectiveness of electromyographic biofeedback training on quadriceps muscle strength in osteoarthritis of knee. 2011; 29(2)
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.
citation: 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.
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.