Stress Urinary Incontinence1NCT05366426
Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence
A study testing EMG biofeedback program: and Pelvic floor muscle training home exercise program: in people with Stress Urinary Incontinence, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- EMG biofeedback program: and Pelvic floor muscle training home exercise program:
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2022to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi Evran University
Kırşehir, City Centre, 40100
About this study
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- EMG biofeedback program:, Sham EMG biofeededback:, Pelvic floor muscle training home exercise program:
- Keywords
- Stress Urinary Incontinence, EMG biofeedback, Quality of life
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Pelvic floor muscle training exercise program will be applied with EMG biofeedback. Receives: 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. Receives: 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 Receives: Other: Pelvic floor muscle training home exercise program: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 20th week (3 months after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start19 Aug 2022
- Primary completion7 Apr 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Cigdem Karacay, Kirsehir Ahi Evran Universitesi
- Investigators
- Basak Cigdem Karacay, Asisst Prof, Study director, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366426
- Sponsor's protocol ID
- 5
- Acronym
- 1
- Status last verified
- Dec 2024
- First submitted
- 5 May 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23443345Wu 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.
PubMed 34176082
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05366426
- Acronym / sponsor ID
- 1 / 5
- Conditions
- Stress Urinary Incontinence
- Keywords
- Stress Urinary Incontinence, EMG biofeedback, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomised controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: EMG biofeedback program:, Other: Pelvic floor muscle training home exercise program:Pelvic floor muscle training exercise program will be applied with EMG biofeedback. |
| Sham Group | Sham comparator | Other: Sham EMG biofeededback:, Other: Pelvic floor muscle training home exercise program:Pelvic floor muscle training exercise program will be applied with EMG biofeedback as a sham. |
| Control Group | Other | Other: Pelvic floor muscle training home exercise program:Pelvic floor muscle training program will be applied as home exercise |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG biofeedback program: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. | Other | Experimental group |
| Sham EMG biofeededback: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). | Other | Sham Group |
| Pelvic floor muscle training home exercise program: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. | Other | Control Group, Experimental group, Sham Group |
Primary outcome
International Incontinence Inquiry Form ICIQ-SF
Time frame: 0 (baseline)
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
Time frame: 8th week (after treatment)
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
Time frame: 20th week (3 months after treatment)
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;
Time frame: 0 (baseline)
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;
Time frame: 8th week (after treatment)
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;
Time frame: 20th week (3 months after treatment)
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
Time frame: 0 (baseline)
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
Time frame: 8th week (after treatment)
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
Time frame: 20th week (3 months after treatment)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 23443345Terlikowski 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.
- Background: PubMed 34176082Wu 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.
- Individual participant dataSharing planned: No
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Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basak Cigdem Karacay, Asisst Prof study director
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG biofeedback program: and Pelvic floor muscle training home exercise program: in people with Stress Urinary Incontinence, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Incontinence Inquiry Form ICIQ-SF (time frame: 0 (baseline)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05366426, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.