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Clinical Trials/NCT04687748
NCT04687748
Completed
Not Applicable

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

Riphah International University1 site in 1 country30 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence
Sponsor
Riphah International University
Enrollment
30
Locations
1
Primary Endpoint
Pelvic floor muscle(PFM) Strength
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
May 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Pelvic floor muscle(PFM) Strength

Time Frame: 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

Time Frame: 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 Outcomes

  • Kings health Questionnaire(KHQ)(Post 8th weeks)

Study Sites (1)

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