Synchronized Core-Pelvic Floor Activation in Urinary Incontinence

NCT07387640 — Not applicable, Not yet recruiting, 50 participants, Bezmialem Vakif University

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Synchronized Activation of Core and Pelvic Floor Muscles: A More Effective Strategy for Urinary Incontinence?

RegistryNCT07387640
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment50 (Estimated)
SponsorBezmialem Vakif University (Other)
ConditionsUrinary Incontinence,Stress, Stress Urinary Incontinence, Mixed Incontinence Due to Prolapse of Female Genital Organ, Urinary Incontinence
InterventionsConventional Pelvic Floor Muscle Training, Pelvic Floor and Core Muscle Co-activation Training (Other)
Datesstart 2026-08-30 (estimated), primary completion 2027-06-30 (estimated), completion 2027-08-30 (estimated), first posted 2026-02-04, last updated 2026-07-01
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Urinary Incontinence,Stress All trials for Stress Urinary Incontinence All trials of Conventional Pelvic Floor Muscle Training All trials of Pelvic Floor and Core Muscle Co-activation Training

-Summary

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Pelvic floor muscle trainingActive comparatorOther: Conventional Pelvic Floor Muscle TrainingParticipants will receive conventional pelvic floor muscle training for 12 weeks, at least three days per week
Synchronized Core-Pelvic Floor Muscle TrainingExperimentalOther: Pelvic Floor and Core Muscle Co-activation TrainingParticipants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles for 12 weeks at least three days per week
  • Conventional Pelvic Floor Muscle Training (Other): 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): 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.

+Outcome measures

Primary outcomes

  • International Consultation on Incontinence Questionnaire [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).

Secondary outcomes

  • PERFECT scheme [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
  • Surface electromyography [12 weeks]: This is used to evaluate Core and Pelvic Floor Muscle Activation
  • Urogenital Distress Inventory (UDI-6) [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.
  • the Incontinence Impact Questionnaire (IIQ-7) [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.

+Eligibility

Sex: Female, ages: 18 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
Bezmialem Vakif UniversityIstanbulTurkey (Türkiye)

+Investigators

  • Betül Çınar, Principal investigator, Bezmialem.edu.tr