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Идёт набор NCT07075900

Dynamic Neuromuscular Stabilization vs Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

Без фазы С лечением Stress Urinary Incontinence (SUI) Dynamic Neuromuscular Stabilization Pelvic Floor Muscle Training Muscle Morphology

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dynamic Neuromuscular Stabilization Training, Pelvic Floor Muscle Training.
Кому может быть актуально
Состояния в реестре: Stress Urinary Incontinence (SUI), Dynamic Neuromuscular Stabilization, Pelvic Floor Muscle Training, Muscle Morphology. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of Effects of Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: A Randomized Controlled Trial

Обзор

This randomized controlled trial aims to compare the pre- and post-treatment effects of Dynamic Neuromuscular Stabilization (DNS) training and Pelvic Floor Muscle Training (PFMT) on pelvic floor muscle function, pelvic floor morphometry, urinary symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI). Participants diagnosed with SUI by a specialist physician will be randomly assigned to one of three groups: DNS, PFMT, or a control group. Both DNS and PFMT interventions will be delivered as 12-week home exercise programs, performed five days a week and at least three times per day. To support adherence, participants will use an exercise diary. In addition, participants in the DNS and PFMT groups will attend the clinic twice a week for supervised sessions led by a physiotherapist. The control group will receive a brochure containing lifestyle and bladder health recommendations but will not engage in any structured exercise program.

Подробное описание

Stress urinary incontinence (SUI) is defined by the International Continence Society as involuntary urine leakage due to insufficient urethral closure pressure during episodes of increased intra-abdominal pressure (IAP), such as coughing, sneezing, laughing, or physical activity. The continence mechanism involves intrinsic urethral closure, structural support of the urethra, and lumbopelvic stability. These components are interconnected through the endopelvic fascia and neural pathways.

The core musculature-including the diaphragm, transversus abdominis (TrA), pelvic floor muscles, and lumbar multifidus-functions synergistically within the myofascial system to regulate IAP. This coordination is essential for maintaining the optimal function of genitourinary organs, especially the bladder.

Dynamic Neuromuscular Stabilization (DNS) targets this integrated spinal stabilization system. DNS exercises are based on developmental kinesiology principles, comparing adult stabilization patterns to those of healthy infants. The goal is to retrain the neuromuscular system through repetitive, functional movements to restore automatic IAP regulation and trunk stability.

Although DNS has demonstrated clinical effectiveness in managing musculoskeletal disorders, cerebral palsy, hemiplegia, and athletic injuries, its role in the management of SUI remains underexplored. By promoting synchronous activation of the deep stabilizers-including the diaphragm, TrA, multifidus, and pelvic floor-DNS may offer a more comprehensive therapeutic approach than isolated pelvic floor muscle training.

In this context, the main questions of this study it aims to answer are:

Does Dynamic Neuromuscular Stabilization (DNS) training have an effect on pelvic floor muscle function, pelvic floor morphometry, symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI)? Does Pelvic Floor Muscle Training (PFMT) improve pelvic floor muscle function, pelvic floor morphometry, symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI)? Is there a difference between DNS exercises and PFMT in terms of their effects on pelvic floor muscle function, pelvic floor morphometry, symptoms, quality of life, sexual function, and physical activity levels before and after treatment in women with SUI?

Вмешательства

  • Другое Dynamic Neuromuscular Stabilization Training
    According to the principles of Dynamic Neuromuscular Stabilization (DNS), proper activation of the integrated spinal stabilization system requires that the abdominal muscles expand not only in the caudal direction but also posteriorly and laterally.Therefore, firstly, the physiotherapist will assess the expansion of the entire abdominal wall and teach the patient to regulate intra-abdominal pressure through correct breathing techniques. During training and exercises, a belt will be used. Partici
  • Другое Pelvic Floor Muscle Training
    Participants in the PFMT group will undergo a structured pelvic floor muscle training program supervised by a physiotherapist. The training will include verbal and manual instructions to ensure correct identification and isolated activation of the pelvic floor muscles without compensatory movements from the gluteal, abdominal, or thigh muscles using a NeuroTrac Simplex EMG-Biofeedback device. The exercise protocol will consist of both slow and fast contractions, focusing on endurance, strength,

Первичные конечные точки

  • 1-Hour Pad test [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
  • Pelvic Floor Morphometry [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
  • Pelvic Floor Muscle Strength and Endurance [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
  • Incontinence Quality of Life Questionnaire (I-QOL) [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
  • Incontinence Episodes and Number of Pads Used (from 3-Day Bladder Diary) [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
Вторичные конечные точки (5)
  • 24-h Pad Test [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
  • Frequency, Nocturia, and Fluid Intake [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
  • Pelvic Floor Muscle Strength (Digital Vaginal Palpation - Oxford Scale) [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
  • Female Sexual Function Index (FSFI) [Срок оценки: Baseline and 12th week (at the end of the exercise program)]
  • Physical Activity Levels [Срок оценки: Baseline and 12th week (at the end of the exercise program)]

Критерии участия

Критерии включения

  • Female participants aged between 18 and 65 years
  • Diagnosed with stress urinary incontinence or stress-dominant mixed urinary incontinence by a specialist physician
  • Having the ability to voluntarily contract the pelvic floor muscles
  • Literate in Turkish
  • Willing and voluntarily consenting to participate in the study

Критерии исключения

  • Pregnancy
  • Presence of urgency-predominant urinary incontinence symptoms or fecal incontinence
  • Inability to understand or cooperate with assessment procedures
  • Presence of any neurological or rheumatological disease
  • Severe cardiac or pulmonary disease
  • Uncontrolled diabetes mellitus or hypertension
  • Chronic liver and/or kidney failure
  • Advanced pelvic organ prolapse (greater than grade 2)
  • History of abdominal or pelvic surgery (including cesarean section) within the past year
  • History of spinal surgery
  • Current urinary tract infection
  • History of pelvic radiation therapy
  • Presence of spinal deformity
  • History of acute low back pain within the past 4-6 weeks
  • Receiving pelvic floor muscle training within the past three months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ege University, Faculty of Medicine, Department of Obstetrics & Gynecology — Izmir

Идентификаторы

NCT: NCT07075900 · DYNAPELVIS-SUI2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗