Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in Vaginal Pressure Measurement with Perineometer
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Core Stabilization Exercises with Kegel Exercises
Intervention: Core stabilization exercises with Kegel exercises (Behavioral)
Kegel Exercises
Intervention: Kegel exercises (Behavioral)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in King's Health Questionnaire (KHQ)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Muscle Strength Examination with Digital Palpation(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Pad Test (24 hours)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Bladder Diary (3 days)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Incontinence Impact Questionnaire (IIQ-7)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
- Change in Urogenital Distress Inventory (UDI-6)(Baseline (before intervention), immediately after intervention, 10 weeks after intervention)
Investigators
Merve Dikici Yağlı
Principal Investigator
Istanbul University