Clinical trial NCT05610761: Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence
Official title: Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
incontinence rehabilitation
incontinence exercises
core stabilization exercises
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Women between the ages of 18 - 55
2. Diagnosis of stress and stress predominant mixed urinary incontinence
3. Pelvic floor muscle strength ≥ 3
4. BMI ≤ 35 kg/m2
5. ≥ 1 complaint of urinary incontinence in the last month

Exclusion Criteria:

1. Pregnancy and postpartum first 6 weeks
2. Other types of incontinence and stress type 3 incontinence
3. Urinary tract infection
4. Pelvic organ prolapse advanced stage (Stage ≥ 2)
5. History of pelvic surgery or pelvic tumor
6. Surgical treatment for urinary incontinence
7. History of serious systemic or neurological disease (Severe cardiovascular disease, advanced COPD, CVO and/or Cancer, Parkinson's etc.)
8. Severe low back and/or pelvic pain

Primary outcomes:
measure: Change in Vaginal Pressure Measurement with Perineometer
timeFrame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
measure: Change in Incontinence Severity Index (ISI)
timeFrame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Secondary outcomes:
measure: Change in Muscle Strength Examination with Digital Palpation
timeFrame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
measure: Change in Pad Test (24 hours)
timeFrame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
measure: Change in Bladder Diary (3 days)
timeFrame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
measure: Change in Incontinence Impact Questionnaire (IIQ-7)
timeFrame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
measure: Change in Urogenital Distress Inventory (UDI-6)
timeFrame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
measure: Change in King's Health Questionnaire (KHQ)
timeFrame: Baseline (before intervention), immediately after intervention, 10 weeks after intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
state: Fatih
Study officials:
affiliation: Istanbul University
name: Merve Dikici Yağlı, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University
name: Ayşe Karan, Professor
role: PRINCIPAL_INVESTIGATOR
References: