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Набор скоро начнётся NCT07663968

Extracorporeal Shock Wave Therapy to Kegel's Exercise in Management of Female Stress Urinary

Без фазы С лечением Female Stress Urinary Incontinence

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: low-intensity extracorporeal shock (LiESWT), Kegel's exercises (KE).
Кому может быть актуально
Состояния в реестре: Female Stress Urinary Incontinence. Базовые параметры: 25 лет — 60 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Additive Role of Low-intensity Extracorporeal Shock Wave Therapy to Kegel's Exercise in Management of Female Stress Urinary Incontinence : A Prospective Randomized Study

Обзор

Stress urinary incontinence (SUI) is a common pelvic floor disorder among women, especially those with a history of childbirth, aging, or pelvic surgery. Stress urinary incontinence is defined as the complaint of involuntary leakage on effort or exertion, or on sneezing or coughing. The condition significantly affects quality of life, emotional well-being, and daily functioning.

Подробное описание

Many women believe that urinary incontinence is an inevitable part of aging or the aftermath of childbirth and do not seek treatment because of embarrassment or a lack of knowledge about available therapies.

The main underlying mechanism of SUI is the weakening of the pelvic floor muscles and connective tissues supporting the bladder and urethra. This structural compromise leads to urethral hypermobility and insufficient urethral closure during physical strain.

Risk factors include vaginal delivery, menopause, obesity, and chronic respiratory conditions.

Effective treatment targets these musculoskeletal deficits to restore continence and reduce leakage episodes.

Kegel's exercise (KE), also known as pelvic floor muscle training, is the first-line conservative treatment for SUI. It involves repetitive contractions and relaxations of pelvic floor muscles to improve their strength, endurance, and coordination.

Pelvic Floor Muscle Training (PFMT) has shown positive outcomes in reducing urinary leakage and improving quality of life. However, patient adherence, correct technique, and the chronicity of symptoms influence its effectiveness. In some cases, KE alone may not provide sufficient relief, especially in moderate to severe SUI.

Low-intensity extracorporeal shock wave therapy (LiESWT) is a non-invasive modality that uses acoustic waves to stimulate tissue regeneration, angiogenesis, and neuromuscular repair. Originally developed for urological and musculoskeletal disorders, its application has expanded to include female pelvic floor dysfunctions. LiESWT has shown promising results in improving urinary control by enhancing blood flow and tissue remodeling in the pelvic region.

Its safety, lack of anesthesia, and outpatient delivery make it an attractive complementary therapy.

The integration of LiESWT with KE is hypothesized to provide synergistic effects.

While Kegel's exercises strengthen muscle tone, LiESWT enhances vascular and cellular repair, potentially accelerating functional improvement. The combination targets both structural and physiological aspects of SUI. This dual approach may be especially beneficial for specific patients who have plateaued with PFMT alone or those seeking non-surgical alternatives with quicker results.

Recent studies have suggested that LiESWT can reduce urinary incontinence severity, but high-quality evidence, especially in combination with PFMT, remains limited. Most available research focuses either on LiESWT or KE separately.

There is a lack of comparative trials directly evaluating the additive benefit of combining both interventions in a structured treatment plan. Therefore, more comprehensive studies are required to determine whether the combination yields superior outcomes in terms of continence, patient satisfaction, and long-term efficacy.

A well-structured clinical comparison between combined LiESWT and KE versus Kegel's alone can fill an essential gap in SUI management. strategies. Such research can provide data on effectiveness, patient compliance, and functional outcomes. It can also guide clinicians on optimizing conservative treatment pathways before progressing to pharmacological or surgical options. Furthermore, evaluating cost-effectiveness and patient-reported outcomes can inform health policy and patient counseling.

The present study aims to assess the additive role of LiESWT to KE for female stress urinary incontinence.

Вмешательства

  • Лучевая терапия low-intensity extracorporeal shock (LiESWT)
    receives low-intensity extracorporeal shock (LiESWT) once weekly. Frequency: 3 Hz, 3000 shocks/session; Duration: 15-20 minutes/session placed on the perineal region, the left side, and the right side of the labia minora.
  • Поведенческое Kegel's exercises (KE)
    Daily Kegel's exercise (KE) Frequency: 3 sessions/day each A session is 10 repetitive pelvic floor muscle contractions. Each contraction will be held for 5 seconds, followed by 5 seconds of relaxation for 8 weeks.

Первичные конечные точки

  • Change in frequency and severity of stress urinary incontinence episodes [Срок оценки: Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.]
Вторичные конечные точки (1)
  • Change in quality of life [Срок оценки: Patients will be assessed at 4 weeks, 8 weeks, 12 weeks, and 3 months from the date of the intervention startup.]

Критерии участия

Критерии включения

  • Married Females
  • Diagnosed with stress urinary incontinence, confirmed by clinical evaluation.
  • Ability and willingness to perform KE and attend follow-up visits.
  • Accepting informed consent.

Критерии исключения

  • Mixed urinary incontinence.
  • Active urinary tract infection (symptomatic or laboratory) confirmed).
  • Known coagulopathy or ongoing anticoagulant therapy.
  • Neurological disorders (e.g., multiple sclerosis, stroke, spinal cord injury) or use of medications affecting bladder control.
  • Pregnancy or recent childbirth (within 6 months)
  • History of pelvic malignancy affecting urinary continence.
  • History of recent surgical intervention or indicated for surgery for urinary incontinence.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07663968 · extracorporeal shock

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗