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Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence (1)

Primary Purpose

Stress Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EMG biofeedback program:
Sham EMG biofeededback:
Pelvic floor muscle training home exercise program:
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress Urinary Incontinence, EMG biofeedback, Quality of life

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1.30-65 years old women clinical diagnoses of Urinary Incontinence 2. Clinical diagnoses of Stress Urinary Incontinence (SUI) or Mixt Urinary Incontinence (MUI) with a dominant Stress Urinary Incontinence component 3.Must be have not received treatment with any physical therapy modality in the last 3 months 4.Must be urinary incontinence severity of at least 5 points on Visual Analog Scale 5.Must be able to signed the informed consent form

Exclusion Criteria:

  1. Severe systemic disease that prevents exercise (Cardiovascular disease, COPD, CVO and/or cancer)
  2. Pure urge or MUI with a dominant urge component
  3. Plan to change or change medical treatment within the last 3 months due to UUI
  4. Visual, auditory, or cognitive deficits that are not suitable for treatment requirements
  5. High-intensity sports activities for at least half an hour, at least 2 times a week

Sites / Locations

  • Ahi Evran UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Experimental group

Sham Group

Control Group

Arm Description

Pelvic floor muscle training exercise program will be applied with EMG biofeedback.

Pelvic floor muscle training exercise program will be applied with EMG biofeedback as a sham.

Pelvic floor muscle training program will be applied as home exercise

Outcomes

Primary Outcome Measures

International Incontinence Inquiry Form ICIQ-SF
International Incontinence Inquiry Form ICIQ-SF Avery et al. and it was reported that the sensitivity, reliability and validity of the scale were high (1). The scale is available in four dimensions. In the first dimension, the frequency of urinary incontinence, the amount of urinary incontinence in the second dimension, the effect of urinary incontinence on daily life in the third dimension, and the conditions that cause urinary incontinence in the fourth dimension are questioned. It was validated in Turkish in 2004 and started to be used in our country.
International Incontinence Inquiry Form ICIQ-SF
International Incontinence Inquiry Form ICIQ-SF Avery et al. and it was reported that the sensitivity, reliability and validity of the scale were high (1). The scale is available in four dimensions. In the first dimension, the frequency of urinary incontinence, the amount of urinary incontinence in the second dimension, the effect of urinary incontinence on daily life in the third dimension, and the conditions that cause urinary incontinence in the fourth dimension are questioned. It was validated in Turkish in 2004 and started to be used in our country.
International Incontinence Inquiry Form ICIQ-SF
International Incontinence Inquiry Form ICIQ-SF Avery et al. and it was reported that the sensitivity, reliability and validity of the scale were high (1). The scale is available in four dimensions. In the first dimension, the frequency of urinary incontinence, the amount of urinary incontinence in the second dimension, the effect of urinary incontinence on daily life in the third dimension, and the conditions that cause urinary incontinence in the fourth dimension are questioned. It was validated in Turkish in 2004 and started to be used in our country.
Pad test;
Pad test; It is one of the objective tests showing the presence and degree of UI. In the one-hour pad test standardized by ICS, the patient is asked to use a pad of known weight for one hour following 500 mL of non-sodium oral hydration for 15 minutes without urinating. During this period, 30 patients walking, going up and down stairs, sitting up 10 times, coughing 10 times, running for 1 minute, bending down 5 times and washing hands for 1 minute. The weight difference measured on the pad at the end of 1 hour is considered to indicate the amount of urine that has escaped. This amount; If it is less than 1 gram, it is definitely dry, if it is between 2-10 grams, it is considered as mild moderate urinary incontinence, between 10-50 grams as severe urinary incontinence, and over 50 grams as very severe urinary incontinence. To increase the reliability of the test, the duration of the test can be extended from 2 hours to 48 hours.
Pad test;
Pad test; It is one of the objective tests showing the presence and degree of UI. In the one-hour pad test standardized by ICS, the patient is asked to use a pad of known weight for one hour following 500 mL of non-sodium oral hydration for 15 minutes without urinating. During this period, 30 patients walking, going up and down stairs, sitting up 10 times, coughing 10 times, running for 1 minute, bending down 5 times and washing hands for 1 minute. The weight difference measured on the pad at the end of 1 hour is considered to indicate the amount of urine that has escaped. This amount; If it is less than 1 gram, it is definitely dry, if it is between 2-10 grams, it is considered as mild moderate urinary incontinence, between 10-50 grams as severe urinary incontinence, and over 50 grams as very severe urinary incontinence. To increase the reliability of the test, the duration of the test can be extended from 2 hours to 48 hours.
Pad test;
Pad test; It is one of the objective tests showing the presence and degree of UI. In the one-hour pad test standardized by ICS, the patient is asked to use a pad of known weight for one hour following 500 mL of non-sodium oral hydration for 15 minutes without urinating. During this period, 30 patients walking, going up and down stairs, sitting up 10 times, coughing 10 times, running for 1 minute, bending down 5 times and washing hands for 1 minute. The weight difference measured on the pad at the end of 1 hour is considered to indicate the amount of urine that has escaped. This amount; If it is less than 1 gram, it is definitely dry, if it is between 2-10 grams, it is considered as mild moderate urinary incontinence, between 10-50 grams as severe urinary incontinence, and over 50 grams as very severe urinary incontinence. To increase the reliability of the test, the duration of the test can be extended from 2 hours to 48 hours.
The King's Health Questionnaire
The King's Health Questionnaire (KSA) is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. In addition to two single-item questions such as general health status and impact on quality of life, it includes 7 sub-headings consisting of multiple items. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). Scores for other KSA domains range from 0 (best) to -100 (worst). Turkish validity and reliability was established (3).
The King's Health Questionnaire
The King's Health Questionnaire (KSA) is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. In addition to two single-item questions such as general health status and impact on quality of life, it includes 7 sub-headings consisting of multiple items. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). Scores for other KSA domains range from 0 (best) to -100 (worst). Turkish validity and reliability was established (3).
The King's Health Questionnaire
The King's Health Questionnaire (KSA) is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. In addition to two single-item questions such as general health status and impact on quality of life, it includes 7 sub-headings consisting of multiple items. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). Scores for other KSA domains range from 0 (best) to -100 (worst). Turkish validity and reliability was established (3).

Secondary Outcome Measures

Full Information

First Posted
May 5, 2022
Last Updated
February 8, 2023
Sponsor
Kirsehir Ahi Evran Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05366426
Brief Title
Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence
Acronym
1
Official Title
Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi

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
The aim of this randomized controlled study was to compare the EMG biofeedback method with pelvic floor muscle (PTC) exercises and Sham EMG biofeedback group in women with stress urinary incontinence (SUI) on pelvic floor muscle strength, trunk endurance, subjective perception of improvement, severity of complaints, pad test and quality of life. to determine its effectiveness.
Detailed Description
Urogynecological complaints have medical and social aspects that negatively affect quality of life. are problems. depression, anxiety, low productivity at work, social isolation and associated with sexual dysfunction. Urinary incontinence (UI), which has serious negative effects on people's quality of life, psychological state and physical health, and especially affects older women, stands out as an important public health problem with the prolongation of the average life expectancy. The two most common types of UI in women are stress urinary incontinence (SUI) and urge urinary incontinence (UI). While SUI is the involuntary leakage of urine typically during coughing, sneezing and other physical activities; UUI is defined as urinary incontinence associated with urgency with a sudden and forced need to urinate. The simultaneous presence of SUI and UUI symptoms is defined as mixed urinary incontinence (MUI). Treatment options of SUI, which are divided into conservative and surgical treatment, are conservative treatment options; behavioral therapy (changing lifestyle and dietary habits and bladder training) and PTC rehabilitation (PTK exercises, biofeedback, electrical stimulation, electromagnetic stimulation, neuromodulation and vaginal issues). With PTK exercises, it is aimed to work the levator ani muscle group. These exercises are described as contractions and relaxation periods lasting 10 seconds. It is recommended to be applied in 3 different positions while lying, sitting and standing. Increasing the number of contractions gradually and reaching 60 repetitions per day is targeted in the treatment (1). One of the ways to teach PTK exercises is "biofeedback" (BF). This method provides visual and auditory feedback while teaching the correct contraction of the muscles (2). Since it is an active method, it is thought that the increase in PTK power is higher. Superficial or internal electrodes can be used (3). The investigators will use surface electrodes in our project. In a recent meta-analysis in the literature (4); In the current meta-analysis on the effectiveness of EMG biofeedback in patients with SUI, it was reported that pelvic floor muscle training combined with EMG-BF achieved better results than pelvic floor muscle training alone in the management of SUI, but randomized studies are still needed to confirm the results. To determine the effectiveness of EMG biofeedback method on pelvic floor muscle strength, severity of complaints, pad test and quality of life in women with stress urinary incontinence (SUI) by comparing them with pelvic floor muscle (PTK) exercises and Sham EMG biofeedback group. In our project, the investigators will be able to determine whether the EMG biofeedback exercise performed with the device is really superior to the exercise performed by the patient himself, using the Sham group. Thus, the results of our project; It will provide scientific data for teaching patients about pelvic floor muscle training in the clinic and for use in urinary rehabilitation of SUI patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress Urinary Incontinence, EMG biofeedback, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled Trial
Masking
ParticipantInvestigator
Masking Description
The prospective, randomized and controlled interventional study with a three-month follow-up period will be carried out in a single center. Female patients with a clinical diagnosis of stress urinary incontinence will be included in the study.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Pelvic floor muscle training exercise program will be applied with EMG biofeedback.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Pelvic floor muscle training exercise program will be applied with EMG biofeedback as a sham.
Arm Title
Control Group
Arm Type
Other
Arm Description
Pelvic floor muscle training program will be applied as home exercise
Intervention Type
Other
Intervention Name(s)
EMG biofeedback program:
Intervention Description
Superficial electrodes and EMG-guided biofeedback will be applied to the perineal region 3 days a week for 8 weeks, so that patients can receive visual and auditory feedback during exercise.
Intervention Type
Other
Intervention Name(s)
Sham EMG biofeededback:
Intervention Description
3 days a week for 8 weeks; Surface electrodes will be attached as in the EMG Biofeedback group, but unlike the EMG biofeedback group, they will exercise without any visual and auditory feedback (1).
Intervention Type
Other
Intervention Name(s)
Pelvic floor muscle training home exercise program:
Intervention Description
Pelvic floor muscle training home exercise program: A home exercise program was given to all patients who had learned to perform correct pelvic floor muscle contraction with the pre-treatment evaluation. In the home exercise program, patients in three positions (sitting, lying and standing) are required to perform two to three rapid contractions of 15 repetitions in each set, three times a day, followed by slow contractions by keeping the PTC tense for 8-10 seconds, and then give a 10-second rest period after slow contractions. has been told. All 3 groups received PTK exercise program.
Primary Outcome Measure Information:
Title
International Incontinence Inquiry Form ICIQ-SF
Description
International Incontinence Inquiry Form ICIQ-SF Avery et al. and it was reported that the sensitivity, reliability and validity of the scale were high (1). The scale is available in four dimensions. In the first dimension, the frequency of urinary incontinence, the amount of urinary incontinence in the second dimension, the effect of urinary incontinence on daily life in the third dimension, and the conditions that cause urinary incontinence in the fourth dimension are questioned. It was validated in Turkish in 2004 and started to be used in our country.
Time Frame
0 (baseline)
Title
International Incontinence Inquiry Form ICIQ-SF
Description
International Incontinence Inquiry Form ICIQ-SF Avery et al. and it was reported that the sensitivity, reliability and validity of the scale were high (1). The scale is available in four dimensions. In the first dimension, the frequency of urinary incontinence, the amount of urinary incontinence in the second dimension, the effect of urinary incontinence on daily life in the third dimension, and the conditions that cause urinary incontinence in the fourth dimension are questioned. It was validated in Turkish in 2004 and started to be used in our country.
Time Frame
8th week (after treatment)
Title
International Incontinence Inquiry Form ICIQ-SF
Description
International Incontinence Inquiry Form ICIQ-SF Avery et al. and it was reported that the sensitivity, reliability and validity of the scale were high (1). The scale is available in four dimensions. In the first dimension, the frequency of urinary incontinence, the amount of urinary incontinence in the second dimension, the effect of urinary incontinence on daily life in the third dimension, and the conditions that cause urinary incontinence in the fourth dimension are questioned. It was validated in Turkish in 2004 and started to be used in our country.
Time Frame
20th week (3 months after treatment)
Title
Pad test;
Description
Pad test; It is one of the objective tests showing the presence and degree of UI. In the one-hour pad test standardized by ICS, the patient is asked to use a pad of known weight for one hour following 500 mL of non-sodium oral hydration for 15 minutes without urinating. During this period, 30 patients walking, going up and down stairs, sitting up 10 times, coughing 10 times, running for 1 minute, bending down 5 times and washing hands for 1 minute. The weight difference measured on the pad at the end of 1 hour is considered to indicate the amount of urine that has escaped. This amount; If it is less than 1 gram, it is definitely dry, if it is between 2-10 grams, it is considered as mild moderate urinary incontinence, between 10-50 grams as severe urinary incontinence, and over 50 grams as very severe urinary incontinence. To increase the reliability of the test, the duration of the test can be extended from 2 hours to 48 hours.
Time Frame
0 (baseline)
Title
Pad test;
Description
Pad test; It is one of the objective tests showing the presence and degree of UI. In the one-hour pad test standardized by ICS, the patient is asked to use a pad of known weight for one hour following 500 mL of non-sodium oral hydration for 15 minutes without urinating. During this period, 30 patients walking, going up and down stairs, sitting up 10 times, coughing 10 times, running for 1 minute, bending down 5 times and washing hands for 1 minute. The weight difference measured on the pad at the end of 1 hour is considered to indicate the amount of urine that has escaped. This amount; If it is less than 1 gram, it is definitely dry, if it is between 2-10 grams, it is considered as mild moderate urinary incontinence, between 10-50 grams as severe urinary incontinence, and over 50 grams as very severe urinary incontinence. To increase the reliability of the test, the duration of the test can be extended from 2 hours to 48 hours.
Time Frame
8th week (after treatment)
Title
Pad test;
Description
Pad test; It is one of the objective tests showing the presence and degree of UI. In the one-hour pad test standardized by ICS, the patient is asked to use a pad of known weight for one hour following 500 mL of non-sodium oral hydration for 15 minutes without urinating. During this period, 30 patients walking, going up and down stairs, sitting up 10 times, coughing 10 times, running for 1 minute, bending down 5 times and washing hands for 1 minute. The weight difference measured on the pad at the end of 1 hour is considered to indicate the amount of urine that has escaped. This amount; If it is less than 1 gram, it is definitely dry, if it is between 2-10 grams, it is considered as mild moderate urinary incontinence, between 10-50 grams as severe urinary incontinence, and over 50 grams as very severe urinary incontinence. To increase the reliability of the test, the duration of the test can be extended from 2 hours to 48 hours.
Time Frame
20th week (3 months after treatment)
Title
The King's Health Questionnaire
Description
The King's Health Questionnaire (KSA) is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. In addition to two single-item questions such as general health status and impact on quality of life, it includes 7 sub-headings consisting of multiple items. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). Scores for other KSA domains range from 0 (best) to -100 (worst). Turkish validity and reliability was established (3).
Time Frame
0 (baseline)
Title
The King's Health Questionnaire
Description
The King's Health Questionnaire (KSA) is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. In addition to two single-item questions such as general health status and impact on quality of life, it includes 7 sub-headings consisting of multiple items. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). Scores for other KSA domains range from 0 (best) to -100 (worst). Turkish validity and reliability was established (3).
Time Frame
8th week (after treatment)
Title
The King's Health Questionnaire
Description
The King's Health Questionnaire (KSA) is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. In addition to two single-item questions such as general health status and impact on quality of life, it includes 7 sub-headings consisting of multiple items. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). Scores for other KSA domains range from 0 (best) to -100 (worst). Turkish validity and reliability was established (3).
Time Frame
20th week (3 months after treatment)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female patients
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.30-65 years old women clinical diagnoses of Urinary Incontinence 2. Clinical diagnoses of Stress Urinary Incontinence (SUI) or Mixt Urinary Incontinence (MUI) with a dominant Stress Urinary Incontinence component 3.Must be have not received treatment with any physical therapy modality in the last 3 months 4.Must be urinary incontinence severity of at least 5 points on Visual Analog Scale 5.Must be able to signed the informed consent form Exclusion Criteria: Severe systemic disease that prevents exercise (Cardiovascular disease, COPD, CVO and/or cancer) Pure urge or MUI with a dominant urge component Plan to change or change medical treatment within the last 3 months due to UUI Visual, auditory, or cognitive deficits that are not suitable for treatment requirements High-intensity sports activities for at least half an hour, at least 2 times a week
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basak Cigdem Karacay, Asisst Prof
Phone
+905445094803
Email
basak.cigdemkaracay@ahievran.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basak Cigdem Karacay, Asisst Prof
Organizational Affiliation
Kirsehir Ahi Evran Universitesi
Official's Role
Study Director
Facility Information:
Facility Name
Ahi Evran University
City
Kırşehir
State/Province
City Centre
ZIP/Postal Code
40100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basak Cigdem Karacay, Assit Prof
Phone
+905445094803
Email
basak.cigdemkaracay@ahivran.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23443345
Citation
Terlikowski R, Dobrzycka B, Kinalski M, Kuryliszyn-Moskal A, Terlikowski SJ. Transvaginal electrical stimulation with surface-EMG biofeedback in managing stress urinary incontinence in women of premenopausal age: a double-blind, placebo-controlled, randomized clinical trial. Int Urogynecol J. 2013 Oct;24(10):1631-8. doi: 10.1007/s00192-013-2071-5. Epub 2013 Feb 27.
Results Reference
background
PubMed Identifier
34176082
Citation
Wu X, Zheng X, Yi X, Lai P, Lan Y. Electromyographic Biofeedback for Stress Urinary Incontinence or Pelvic Floor Dysfunction in Women: A Systematic Review and Meta-Analysis. Adv Ther. 2021 Aug;38(8):4163-4177. doi: 10.1007/s12325-021-01831-6. Epub 2021 Jun 27.
Results Reference
background

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Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence

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