- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05610761
Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence
Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence: Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fatih
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Istanbul, Fatih, Turkey, 34093
- Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Core Stabilization Exercises with Kegel Exercises
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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.
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ACTIVE_COMPARATOR: Kegel Exercises
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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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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Change in Incontinence Severity Index (ISI)
Time Frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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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).
|
Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Muscle Strength Examination with Digital Palpation
Time Frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
|
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. |
Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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Change in Pad Test (24 hours)
Time Frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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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 |
Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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Change in Bladder Diary (3 days)
Time Frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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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.
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Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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Change in Incontinence Impact Questionnaire (IIQ-7)
Time Frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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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.
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Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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Change in Urogenital Distress Inventory (UDI-6)
Time Frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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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.
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Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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Change in King's Health Questionnaire (KHQ)
Time Frame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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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.
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Baseline (before intervention), immediately after intervention, 10 weeks after intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Merve Dikici Yağlı, MD, Istanbul University
- Principal Investigator: Ayşe Karan, Professor, Istanbul University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Incontinence Rehab, IstanbulU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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