Stress Urinary IncontinenceNCT05610761
Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence
A study testing Core stabilization exercises with Kegel exercises and Kegel exercises in people with Stress Urinary Incontinence, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In our study, we aimed to evaluate the effects of core stabilization exercises added to traditional Kegel exercises on incontinence and quality of life in women with stress and stress dominant mixed urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Core stabilization exercises with Kegel exercises and Kegel exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2019to 15 Aug 2020
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the ages of 18 - 55
- Diagnosis of stress and stress predominant mixed urinary incontinence
- Pelvic floor muscle strength ≥ 3
- BMI ≤ 35 kg/m2
- ≥ 1 complaint of urinary incontinence in the last month
Who cannot join
- Pregnancy and postpartum first 6 weeks
- Other types of incontinence and stress type 3 incontinence
- Urinary tract infection
- Pelvic organ prolapse advanced stage (Stage ≥ 2)
- History of pelvic surgery or pelvic tumor
- Surgical treatment for urinary incontinence
- History of serious systemic or neurological disease (Severe cardiovascular disease, advanced COPD, CVO and/or Cancer, Parkinson's etc.)
- Severe low back and/or pelvic pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, 34093
About this study
Official title: Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence: Randomized Controlled Trial
In our study, we aimed to evaluate the effects of core stabilization exercises added to traditional Kegel exercises on incontinence and quality of life in women with stress and stress dominant mixed urinary incontinence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Core stabilization exercises with Kegel exercises, Kegel exercises
- Keywords
- stress urinary incontinence, incontinence rehabilitation, incontinence exercises, core stabilization exercises
- 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.
Core stabilization exercises with Kegel exercisesBehavioural
Core stabilization exercise program consists of two phases: teaching the basic movement (contraction of the Transversus abdominis and other muscles with diaphragmatic breathing) and incremental exercises added to the basic movement. The basic movement will be studied before each exercise and then the specified exercises will be added. The physiatrist will teach the exercise program to the patients. The first 6 of the 12 exercises classified according to the degree of difficulty will be performed for 5 weeks, and the next 5 weeks will be moved to the other 6 exercises. The exercises will be performed at least 3 days a week, with 10 repetitions of each movement, and the program will last for 10 weeks. Compliance with the exercise program will be questioned over the phone, and patients will be evaluated with a follow-up form before the study, at the 10th week, and at the 20th week. In addition, the Kegel exercise program specified in the other group will be applied.
Kegel exercisesBehavioural
Kegel Exercises The exercise will start as 2 sets of 10 repetitions in the morning and evening, and after getting used to it, it will be increased to 3 sets of 10 repetitions per day.
The patient, lying on his back with his knees bent, feet slightly apart from each other, will try to lift the breech, urinary tract opening and vagina on the pelvic floor by counting to 5, and should not tighten your abdominal and leg muscles, and should not hold your breath while doing this exercise.
In this way, he will count up to 5 while contracting, then he will relax by counting to 10 (after getting used to it, the holding time will be increased to 10 seconds).
| Study group | Role | What they receive |
|---|---|---|
| Core Stabilization Exercises with Kegel Exercises | Experimental | Not described Receives: Behavioral: Core stabilization exercises with Kegel exercises |
| Kegel Exercises | Active comparator | Not described Receives: Behavioral: Kegel exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Pressure Measurement with Perineometer
The periometer is a manometer attached to a vaginal pressure probe that evaluates pelvic floor muscle (PTC) contraction with an objective result in cmH2O. Normal vaginal pressure value is 30-60 cm H2O.
The probe is advanced 3-5 cm towards the vagina and the patient is asked to contract the perineal muscles. 3 separate measurements are made and a score is created by taking the average of these measurements.
Measured: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Incontinence Severity Index (ISI)
ISI is a simple questionnaire consisting of questioning the frequency and amount of urine leakage, and the score consists of multiplying the answers given to these two groups of questions. Incontinence severity according to scores; mild (score 1-2), moderate (score 3-6), severe (score 8-9), and very severe (score 12).
Measured: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Secondary outcomes (6)
Change in Muscle Strength Examination with Digital Palpation
Patients lie in the supine position, knees straight and legs abducted. The physiatrist inserts two distal phalanxes and one finger into the introitus vagina and tells the patient how to contract correctly, and is asked to hold the fingers firmly. Modified Oxford Scale is used for scoring.
Muscle strength 0: No contraction. 1: Contraction is minimal, can hold fingers for <1 second. 2: Contraction is weak, fingers are not elevated and can hold for 1-3 seconds. 3: With the contraction, the doctor's fingers elevate up to the posterior vaginal wall, can hold for 4-6 seconds, repeat 3 times. 4: Doctor's fingers elevate the posterior vaginal wall, there is a feeling of intense pressure on the fingers, can hold for 7-9 seconds, repeat 3 times. 5: He can do strong contractions for 10 seconds, repeat ≥4 times.
Measured: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Pad Test (24 hours)
The pad test is one of the objective tests that shows the presence and degree of UI. The purpose of pad tests is to determine the amount of incontinence by measuring pad weight. In these tests, the weight of the pad is weighed before and after a certain time interval (1 hour, 24 hours or 48 hours).
In the 24-hour pad test, the pads that the patient leaks for 24 hours are collected and weighed on a sensitive scale, using a precision scale and pads whose weight is known beforehand. The amount of urine leakage is determined by subtracting the weight of the pads used from the score. Scoring; Defined as <1 g definitely dry, 2-10 g mild moderate urinary incontinence, 10-50 g severe urinary incontinence, > 50 g very severe urinary incontinence
Measured: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Bladder Diary (3 days)
Bladder diaries provide information about parameters such as fluid intake and excretion amount of the patient, urinary incontinence and frequency of urination in 24-hour periods. The patient is given 3 forms of 24 hours. He is asked to write down the information including the quality and quantity of all the liquids he has taken for 3 days, the frequency of urination during the day and night, the frequency of urinary incontinence and the triggering event on these forms, together with the hours.
Measured: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Incontinence Impact Questionnaire (IIQ-7)
Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) assess symptom distress and the impact on daily life of urinary incontinence. The patient is asked 7 different questions about how much urinary incontinence affects him in social life. Indicate the degree of being affected in 7 subjects: doing housework, aerobic activities such as walking, swimming, exercise, entertainment activities (such as movies), traveling for more than 30 minutes by car, participation in social activities outside the home, mental health (nervousness, depression), and feelings of frustration. required. 0 is not affected at all, 1 is slightly affected, 2 is moderately affected, and 3 is very affected.
Measured: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Urogenital Distress Inventory (UDI-6)
Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) assess symptom distress and the impact on daily life of urinary incontinence. UDI-6 consists of 6 items: Frequent urination, leakage related to feeling of urgency, leakage related to activity, coughing, or sneezing small amounts of leakage (drops), difficulty emptying the bladder, and pain or discomfort in the lower abdominal or genital area. They are asked to score how much these items affect the quality of life. 0 is not affected at all, 1 is slightly affected, 2 is moderately affected, and 3 is very affected.
Measured: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in King's Health Questionnaire (KHQ)
The King's Health Questionnaire (KHQ) is another comprehensive patient statement-based scoring used to evaluate the impact of urinary incontinence on quality of life.
Measured: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start8 Jul 2019
- Primary completion8 Mar 2020
- Study completion15 Aug 2020
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 Istanbul UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Dikici Yağlı, Istanbul University
- Investigators
- Merve Dikici Yağlı, MD, Principal investigator, Istanbul UniversityAyşe Karan, Professor, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610761
- Sponsor's protocol ID
- Incontinence Rehab, IstanbulU
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yagli MD, Capan N, Cakmak ET, Ugurlucan FG, Yasa C, Karan A. Efficacy of Core Stabilization Exercises in Women with Stress and Stress-Dominant Mixed Urinary Incontinence: A Prospective, Randomized Controlled Study. Int Urogynecol J. 2025 Nov;36(11):2191-2201. doi: 10.1007/s00192-025-06115-z. Epub 2025 Mar 22.
PubMed 40119892Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05610761
- Acronym / sponsor ID
- Incontinence Rehab, IstanbulU
- Conditions
- Stress Urinary Incontinence
- Keywords
- stress urinary incontinence, incontinence rehabilitation, incontinence exercises, core stabilization exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 8 Mar 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 9 Nov 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.
In our study, we aimed to evaluate the effects of core stabilization exercises added to traditional Kegel exercises on incontinence and quality of life in women with stress and stress dominant mixed urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Stabilization Exercises with Kegel Exercises | Experimental | Behavioral: Core stabilization exercises with Kegel exercises |
| Kegel Exercises | Active comparator | Behavioral: Kegel exercises |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the ages of 18 - 55
- Diagnosis of stress and stress predominant mixed urinary incontinence
- Pelvic floor muscle strength ≥ 3
- BMI ≤ 35 kg/m2
- ≥ 1 complaint of urinary incontinence in the last month
Key exclusion criteria (8 listed)
- Pregnancy and postpartum first 6 weeks
- Other types of incontinence and stress type 3 incontinence
- Urinary tract infection
- Pelvic organ prolapse advanced stage (Stage ≥ 2)
- History of pelvic surgery or pelvic tumor
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 |
|---|---|---|
| Core stabilization exercises with Kegel exercisesCore stabilization exercise program consists of two phases: teaching the basic movement (contraction of the Transversus abdominis and other muscles with diaphragmatic breathing) and incremental exercises added to the basic movement. The basic movement will be studied before each exercise and then the specified exercises will be added. The physiatrist will teach the exercise program to the patients. The first 6 of the 12 exercises classified according to the degree of difficulty will be performed for 5 weeks, and the next 5 weeks will be moved to the other 6 exercises. The exercises will be performed at least 3 days a week, with 10 repetitions of each movement, and the program will last for 10 weeks. Compliance with the exercise program will be questioned over the phone, and patients will be evaluated with a follow-up form before the study, at the 10th week, and at the 20th week. In addition, the Kegel exercise program specified in the other group will be applied. | Behavioural | Core Stabilization Exercises with Kegel Exercises |
| Kegel exercisesKegel Exercises The exercise will start as 2 sets of 10 repetitions in the morning and evening, and after getting used to it, it will be increased to 3 sets of 10 repetitions per day. The patient, lying on his back with his knees bent, feet slightly apart from each other, will try to lift the breech, urinary tract opening and vagina on the pelvic floor by counting to 5, and should not tighten your abdominal and leg muscles, and should not hold your breath while doing this exercise. In this way, he will count up to 5 while contracting, then he will relax by counting to 10 (after getting used to it, the holding time will be increased to 10 seconds). | Behavioural | Kegel Exercises |
Primary outcome
Change in Vaginal Pressure Measurement with Perineometer
Time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
The periometer is a manometer attached to a vaginal pressure probe that evaluates pelvic floor muscle (PTC) contraction with an objective result in cmH2O. Normal vaginal pressure value is 30-60 cm H2O. The probe is advanced 3-5 cm towards the vagina and the patient is asked to contract the perineal muscles. 3 separate measurements are made and a score is created by taking the average of these measurements.
Change in Incontinence Severity Index (ISI)
Time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
ISI is a simple questionnaire consisting of questioning the frequency and amount of urine leakage, and the score consists of multiplying the answers given to these two groups of questions. Incontinence severity according to scores; mild (score 1-2), moderate (score 3-6), severe (score 8-9), and very severe (score 12).
6 secondary outcomes
Change in Muscle Strength Examination with Digital Palpation
Time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Pad Test (24 hours)
Time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Bladder Diary (3 days)
Time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Incontinence Impact Questionnaire (IIQ-7)
Time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in Urogenital Distress Inventory (UDI-6)
Time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Change in King's Health Questionnaire (KHQ)
Time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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 9 Nov 2022.
- Derived from this study: PubMed 40119892Yagli MD, Capan N, Cakmak ET, Ugurlucan FG, Yasa C, Karan A. Efficacy of Core Stabilization Exercises in Women with Stress and Stress-Dominant Mixed Urinary Incontinence: A Prospective, Randomized Controlled Study. Int Urogynecol J. 2025 Nov;36(11):2191-2201. doi: 10.1007/s00192-025-06115-z. Epub 2025 Mar 22.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
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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.
Merve Dikici Yağlı, MD principal investigator
Istanbul University
Ayşe Karan, Professor principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercises with Kegel exercises and Kegel exercises in people with Stress Urinary Incontinence, run by Istanbul University 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 5 inclusion and 8 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 9 Nov 2022. 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. 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?
Change in Vaginal Pressure Measurement with Perineometer (time frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention). The study lists 2 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 NCT05610761, 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 9 Nov 2022.