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Набор скоро начнётся NCT07739550

Low-Intensity Shock Wave Therapy for Refractory Overactive Bladder in Women

Без фазы С лечением Urinary Bladder, Overactive

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 Wave Therapy, Sham Low-Intensity Extracorporeal Shock Wave Therapy.
Кому может быть актуально
Состояния в реестре: Urinary Bladder, Overactive. Базовые параметры: 18 лет — 70 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
Египет
Следующий шаг
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Официальное название

Therapeutic Effects of Low-Intensity Extracorporeal Shock Wave Therapy on Refractory Overactive Bladder Symptoms in Females

Обзор

Overactive bladder is a condition characterized by a sudden and difficult-to-control need to urinate, which may occur with frequent urination, nighttime urination, and urine leakage. Some women continue to experience these symptoms despite lifestyle changes, behavioral therapy, and medication, or they cannot tolerate or decline medical treatment. This study will evaluate whether low-intensity extracorporeal shock wave therapy (Li-ESWT), a non-surgical treatment delivered externally over the lower abdomen, can safely improve refractory overactive bladder symptoms in women. A total of 40 women will be randomly assigned in equal numbers to receive either active Li-ESWT or a sham treatment. Both groups will attend one treatment session each week for six weeks. The sham procedure will be similar to the active treatment in positioning, session duration, and device sound but will not deliver shock wave energy. Symptoms will be assessed using the validated Arabic version of the 8-item Overactive Bladder Questionnaire (OAB-V8) before treatment and during follow-up. The main purpose of the study is to compare the change in OAB-V8 symptom score between the two groups after one month. Additional assessments at three months will include post-void residual urine volume, information from a 3-day voiding diary, the participant's overall impression of improvement, and any treatment-related adverse events. The study hypothesis is that Li-ESWT will improve overactive bladder symptoms and quality of life compared with sham treatment.

Вмешательства

  • Устройство Low-Intensity Extracorporeal Shock Wave Therapy
    Focused low-intensity extracorporeal shock wave therapy will be delivered using the PiezoWave 2 device. Each session will deliver a total of 3000 impulses at an energy density of 0.25 mJ/mm² and a frequency of 3 pulses per second. Treatment will be administered once weekly for 6 weeks.
  • Устройство Sham Low-Intensity Extracorporeal Shock Wave Therapy
    A sham procedure will be administered using the same treatment setup, participant positioning, probe placement, session duration, and device sound as active therapy. A sham probe or zero-energy setting will be used so that no therapeutic shock wave energy is delivered. The procedure will be performed once weekly for 6 weeks.

Первичные конечные точки

  • Overactive Bladder Questionnaire 8-Item Total Score [Срок оценки: Baseline and 1 month after completion of the 6-week treatment]
Вторичные конечные точки (6)
  • Post-Void Residual Urine Volume at 3 Months [Срок оценки: Baseline and 3 months after completion of treatment]
  • Urinary Frequency Recorded in a 3-Day Voiding Diary [Срок оценки: Baseline and 3 months after completion of treatment]
  • Mean Voided Urine Volume Recorded in a 3-Day Voiding Diary [Срок оценки: Baseline and 3 months after completion of treatment]
  • Urgency Level Recorded in a 3-Day Voiding Diary [Срок оценки: Baseline and 3 months after completion of treatment]
  • Urinary Leakage Episodes Recorded in a 3-Day Voiding Diary [Срок оценки: Baseline and 3 months after completion of treatment]
  • Functional Bladder Capacity [Срок оценки: Baseline and 3 months after completion of treatment]

Критерии участия

Критерии включения

  • Female participants aged 18 to 70 years.
  • Symptoms of overactive bladder with an Overactive Bladder Questionnaire 8-Item total score greater than 8.
  • Failure of behavioral therapy and medical treatment for overactive bladder.
  • Refusal of medical treatment for overactive bladder. Ability to understand the study procedures and provide written informed consent.

Критерии исключения

  • Current use of medical treatment for overactive bladder.
  • Cardiac pacemaker or metallic implant in the treatment area.
  • Coagulation disorder or use of anticoagulants that cannot be temporarily discontinued.
  • Active urinary tract infection; participants may be reconsidered after successful treatment and recovery.
  • Urinary bladder stones.
  • Post-void residual urine volume greater than 100 mL.
  • Lower urinary tract surgery within the previous 6 months.
  • Previous pelvic radiation therapy.
  • History of neuropathic disease.
  • Pregnancy or planning to become pregnant.
  • Hepatic, renal, or cardiac impairment.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Ain Shams University Hospital — Cairo

Идентификаторы

NCT: NCT07739550 · FMASU MS 434/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗