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Not yet recruiting NCT07387640

Synchronized Core-Pelvic Floor Activation in Urinary Incontinence

No phase Interventional Urinary Incontinence,Stress Stress Urinary Incontinence Mixed Incontinence Due to Prolapse of Female Genital Organ Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional Pelvic Floor Muscle Training, Pelvic Floor and Core Muscle Co-activation Training.
Who it may be relevant to
Registry conditions: Urinary Incontinence,Stress, Stress Urinary Incontinence, Mixed Incontinence Due to Prolapse of Female Genital Organ, Urinary Incontinence. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Conventional Pelvic Floor Muscle Training
    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.
  • Other Pelvic Floor and Core Muscle Co-activation Training
    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.

Primary outcome measures

  • International Consultation on Incontinence Questionnaire [Time frame: 12 weeks]
Secondary outcome measures (4)
  • PERFECT scheme [Time frame: 12 weeks]
  • Surface electromyography [Time frame: 12 weeks]
  • Urogenital Distress Inventory (UDI-6) [Time frame: 12 weeks]
  • the Incontinence Impact Questionnaire (IIQ-7) [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bezmialem Vakif University — Istanbul

Identifiers

NCT: NCT07387640 · bvubcinar04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗