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临床试验/NCT07387640
NCT07387640
尚未招募
不适用

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

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月30日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
International Consultation on Incontinence Questionnaire

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Pelvic floor muscle training

Active Comparator

Participants will receive conventional pelvic floor muscle training for 12 weeks, at least three days per week

干预措施: Conventional Pelvic Floor Muscle Training (Other)

Synchronized Core-Pelvic Floor Muscle Training

Experimental

Participants will receive pelvic floor muscle training combined with co-activation exercises targeting core muscles for 12 weeks at least three days per week

干预措施: Pelvic Floor and Core Muscle Co-activation Training (Other)

结局指标

主要结局

International Consultation on Incontinence Questionnaire

时间窗: 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).

次要结局

  • PERFECT scheme(12 weeks)
  • Surface electromyography(12 weeks)
  • Urogenital Distress Inventory (UDI-6)(12 weeks)
  • the Incontinence Impact Questionnaire (IIQ-7)(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Betül Çınar

Lecturer, PhD

Bezmialem Vakif University

研究点 (1)

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