Synchronized Core-Pelvic Floor Activation in Urinary Incontinence

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Childbirth within the previous 6 weeks

Severe pelvic organ prolapse

Active vaginal or urinary tract infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Pelvic Floor Muscle Training

    Other intervention

    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.

  • Pelvic Floor and Core Muscle Co-activation Training

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Pelvic floor muscle trainingActive comparator 1 intervention
Group B: Synchronized Core-Pelvic Floor Muscle TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

International Consultation on Incontinence Questionnaire

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

Secondary outcomes

1

PERFECT scheme

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
2

Surface electromyography

This is used to evaluate Core and Pelvic Floor Muscle Activation

Time frame
12 weeks
3

Urogenital Distress Inventory (UDI-6)

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
4

the Incontinence Impact Questionnaire (IIQ-7)

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: