- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387640
Synchronized Core-Pelvic Floor Activation in Urinary Incontinence
Synchronized Activation of Core and Pelvic Floor Muscles: A More Effective Strategy for Urinary Incontinence?
Study Overview
Status
Conditions
Detailed Description
Urinary incontinence is a prevalent condition that negatively affects quality of life and functional independence. Pelvic floor muscle training (PFMT) is recommended as a first-line conservative treatment. Recent evidence suggests that coordinated activation of the pelvic floor muscles with core muscles, including the transversus abdominis and multifidus, may enhance treatment effectiveness.
This randomized controlled study will include women aged 18-65 years diagnosed with stress or mixed urinary incontinence. Eligible participants will be randomly allocated to one of two groups: a conventional pelvic floor muscle training group (control group) or a pelvic floor muscle training plus core muscle co-activation group (intervention group).
Both groups will participate in a 12-week exercise program performed at least three days per week, including one supervised session and two home-based sessions weekly. Outcome measures will be assessed at baseline and after completion of the intervention. Primary outcomes include urinary incontinence severity, while secondary outcomes include pelvic floor muscle function, core muscle activation assessed by surface electromyography, and quality of life.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Betül Çınar
- Phone Number: 4648 +902125232288
- Email: betulbirik@gmail.com
Study Contact Backup
- Name: Betul Çınar
- Phone Number: 4648 +902125232288
- Email: bcinar@bezmialem.edu.tr
Study Locations
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Istanbul, Turkey (Türkiye)
- Bezmialem Vakif University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 65 years
- Diagnosed with stress, urge, or mixed urinary incontinence
- Pelvic floor muscle strength grade ≥ 3 according to the Modified Oxford Scale
- At least one episode of urinary leakage within the last month
Exclusion Criteria:
- Pregnancy
- Childbirth within the previous 6 weeks
- Severe pelvic organ prolapse
- Active vaginal or urinary tract infection
- Presence of neurological or psychiatric disorders
- Malignancy
- Inability to cooperate with assessments or interventions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Pelvic floor muscle training
Participants will receive conventional pelvic floor muscle training for 12 weeks, at least three days per week
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Participants will receive conventional pelvic floor muscle training based on standardized pelvic floor physiotherapy principles.
Exercises will be performed for 12 weeks, at least three days per week, including one supervised session and two home-based sessions.
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Experimental: Synchronized Core-Pelvic Floor Muscle Training
Participants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles for 12 weeks at least three days per week
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Participants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles.
The program will be conducted for 12 weeks with the same frequency and supervision structure as the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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International Consultation on Incontinence Questionnaire
Time Frame: 12 weeks
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This is a brief patient-reported questionnaire used to assess the frequency, severity, and impact of urinary incontinence on quality of life. Minimum Score: 0 Maximum Score: 21 Interpretation: Higher scores indicate worse symptoms and a greater impact on quality of life. Breakdown: The score is the sum of three items: frequency (0-5), amount (0-6), and interference with everyday life (0-10). |
12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surface electromyography
Time Frame: 12 weeks
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This is used to evaluate Core and Pelvic Floor Muscle Activation
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12 weeks
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PERFECT scheme
Time Frame: 12 weeks
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This is used to evaluate Pelvic Floor Muscle Function.
It evaluates four components: Power, Endurance, Repetitions, and Fast contractions.
Higher scores indicate better muscle function
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12 weeks
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Urogenital Distress Inventory (UDI-6)
Time Frame: 12 weeks
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This questionnaire assesses the degree of bother associated with specific urogenital symptoms (e.g., frequent urination, leakage). Minimum Score: 0 Maximum Score: 100 (Standardized Scale) Interpretation: Higher scores indicate worse quality of life (higher distress). Calculation: There are 6 items. Each is rated 0 (Not at all) to 3 (Greatly). The average score of the items is calculated and then multiplied by 33.33 to convert it to a 0-100 scale. |
12 weeks
|
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the Incontinence Impact Questionnaire (IIQ-7)
Time Frame: 12 weeks
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This questionnaire measures the impact of urinary incontinence on activities, roles, and emotional health. Minimum Score: 0 Maximum Score: 100 (Standardized Scale) Interpretation: Higher scores indicate worse quality of life (greater negative impact). Calculation: There are 7 items. Each is rated 0 (Not at all) to 3 (Greatly). Like the UDI-6, the average of the item scores is multiplied by 33.33 to obtain the final 0-100 score. |
12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Betül Çınar, Bezmialem.edu.tr
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
- Urinary Incontinence, Stress
Other Study ID Numbers
- bvubcinar04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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