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EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Electromographic Biofeedback
PFM exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Pelvic floor muscles, Electromyographic Biofeedback, pelvic floor strengthening

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Rehab Center RCRAHS Potohar campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EMG BF Group

Control Group

Arm Description

Pelvic floor muscle contraction will be performed via an S-EMGBF device; patients in the s-EMGBF group will receive visual and auditory feedback.

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

Outcomes

Primary Outcome Measures

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)
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)
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.
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.

Secondary Outcome Measures

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
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

Full Information

First Posted
December 25, 2020
Last Updated
June 11, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04687748
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Pelvic floor muscles, Electromyographic Biofeedback, pelvic floor strengthening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Participants will be selected through purposive sampling technique per inclusion & exclusion criteria. Further, Randomization will be done by sealed envelope method.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMG BF Group
Arm Type
Experimental
Arm Description
Pelvic floor muscle contraction will be performed via an S-EMGBF device; patients in the s-EMGBF group will receive visual and auditory feedback.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds.
Intervention Type
Device
Intervention Name(s)
Electromographic Biofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PFM exercises
Intervention Description
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 Outcome Measure Information:
Title
Pelvic floor muscle(PFM) Strength
Description
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)
Time Frame
Baseline
Title
Pelvic floor muscle(PFM) Strength
Description
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)
Time Frame
Post 8th weeks
Title
Pelvic distress inventory Questionnaire-20
Description
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.
Time Frame
Baseline
Title
Pelvic distress inventory Questionnaire-20
Description
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.
Time Frame
post 8th week
Secondary Outcome Measure Information:
Title
Kings health Questionnaire(KHQ)
Description
Quality of life of patients will be measured by KHQ. It is a 10 items questionairre with rating on 4 item likert scale
Time Frame
Baseline
Title
Kings health Questionnaire(KHQ)
Description
Quality of life of patients will be measured by KHQ. It is a 10 items questionairre with rating on 4 item likert scale
Time Frame
Post 8th weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Post partum females will be recruited in this study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab Center RCRAHS Potohar campus
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32400762
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.
Results Reference
background
Citation
Anwer S QNMMEA. Effectiveness of electromyographic biofeedback training on quadriceps muscle strength in osteoarthritis of knee. 2011; 29(2)
Results Reference
background
PubMed Identifier
32647538
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.
Results Reference
background
PubMed Identifier
31790463
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.
Results Reference
background
PubMed Identifier
26883864
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.
Results Reference
background

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EMG Biofeedback Based Pelvic Floor Training in Post Partum Women

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