Bezmialem Vakif University
Istanbul, Turkey (Türkiye)
NCT Number: NCT07387640
This study aims to investigate whether co-activation of the pelvic floor and core muscles improves treatment outcomes in individuals with urinary incontinence. Participants diagnosed with stress, or mixed urinary incontinence will undergo a 12-week pelvic floor physiotherapy program, with or without additional core muscle co-activation exercises. Changes in urinary incontinence severity, pelvic floor muscle function, core muscle activation, and quality of life will be evaluated.
Trial opening soon.
Get Notified18 year–65 year
Female
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 weeks
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).
Time frame: 12 weeks
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
Time frame: 12 weeks
This is used to evaluate Core and Pelvic Floor Muscle Activation
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Contact information is provided by the study sponsor or research team.
Bezmialem Vakif University
Other
Synchronized Activation of Core and Pelvic Floor Muscles: A More Effective Strategy for Urinary Incontinence?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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