Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence

NCT05366426 | Completed

• 1 other identifier: 5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

Stress Urinary Incontinence; EMG biofeedback; Quality of life

Outcome Measures

Primary Outcomes (9)

• 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.

  0 (baseline)

• 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.

  8th week (after treatment)

• 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.

  20th week (3 months after treatment)

• 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.

  0 (baseline)

• 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.

  8th week (after treatment)

• 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.

  20th week (3 months after treatment)

• 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).

  0 (baseline)

• 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).

  8th week (after treatment)

• 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).

  20th week (3 months after treatment)

Study Arms (3)

Experimental group

EXPERIMENTAL

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

Other: EMG biofeedback program:; Other: Pelvic floor muscle training home exercise program:

Sham Group

SHAM COMPARATOR

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

Other: Sham EMG biofeededback:; Other: Pelvic floor muscle training home exercise program:

Control Group

OTHER

Pelvic floor muscle training program will be applied as home exercise

Other: Pelvic floor muscle training home exercise program:

Interventions

EMG biofeedback program: OTHER

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.

Experimental group

Sham EMG biofeededback: OTHER

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).

Sham Group

Pelvic floor muscle training home exercise program: OTHER

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.

Control Group; Experimental group; Sham Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Gender Eligibility Details: Only female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ahi Evran University

Kırşehir, City Centre, 40100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23443345 BACKGROUND

• 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.

  PMID: 34176082 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Basak Cigdem Karacay, Asisst Prof

  Kirsehir Ahi Evran Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled Trial

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 9, 2022
• Study Start: August 19, 2022
• Primary Completion: April 7, 2024
• Study Completion: July 8, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)