Skip to main content
OpenTrials
Completed

NCT Number: NCT04687748

EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rehab Center RCRAHS Potohar campus

Rawalpindi, Punjab Province, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pelvic floor muscle(PFM) Strength

    Time frame: Baseline

    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)

  2. 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)

  3. Pelvic distress inventory Questionnaire-20

    Time frame: Baseline

    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.

  4. 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

  1. Kings health Questionnaire(KHQ)

    Time frame: Baseline

    Quality of life of patients will be measured by KHQ. It is a 10 items questionairre with rating on 4 item likert scale

  2. Kings health Questionnaire(KHQ)

    Time frame: Post 8th weeks

    Quality of life of patients will be measured by KHQ. It is a 10 items questionairre with rating on 4 item likert scale

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.