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This study intends to determine the effects of Electromyographic biofeedback on performance of pelvic floor muscles in urinary incontinence.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMG BF Group | Experimental | Pelvic floor muscle contraction will be performed via an S-EMGBF device; patients in the s-EMGBF group will receive visual and auditory feedback. |
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| Control Group | Active Comparator | Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Kings health Questionnaire(KHQ) |
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Inclusion Criteria:
Exclusion Criteria:
Post partum females will be recruited in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Huma Riaz, PHD* | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehab Center RCRAHS Potohar campus | Rawalpindi | Punjab Province | 44000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32400762 | Background | 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. | |
| Background | Anwer S QNMMEA. Effectiveness of electromyographic biofeedback training on quadriceps muscle strength in osteoarthritis of knee. 2011; 29(2) | ||
| 32647538 |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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Participants will be selected through purposive sampling technique per inclusion & exclusion criteria. Further, Randomization will be done by sealed envelope method.
|
| 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. |
|
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 |
| Background |
| 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. |
| 31790463 | Background | 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. |
| 26883864 | Background | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |