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Идёт набор NCT06479720

Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder

Фаза IV С лечением Effect of Drug 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: Combined pharmacotherapy with Solifenacin and Mirabegron, Solifenacin with vaginal estrogen cream, Mirabegron with vaginal estrogen cream.
Кому может быть актуально
Состояния в реестре: Effect of Drug, Urinary Bladder, Overactive. Базовые параметры: 40 лет — 90 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
Тайвань
Следующий шаг
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Официальное название

Efficacy and Safety of Solifenacin or Mirabegron With Local Estrogen Versus Combination Treatment With Mirabegron and Solifenacin for Refractory Overactive Bladder

Обзор

To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder

Подробное описание

Women with detrusor overactivity who were refractory to anti-muscarinics or mirabegron were enrolled for prospective study. Patients were divided into three groups: combined pharmacotherapy with solifenacin and mirabegron, solifenacin with vaginal estrogen cream and mirabegron with vaginal estrogen cream. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in episodes of daily micturition, urgency, urinary incontinence and nocturia.

Вмешательства

  • Препарат Combined pharmacotherapy with Solifenacin and Mirabegron
    Solifenacin (5mg) is anticholinergic and Mirabegron (25mg) is a beta-3 adrenergic agonist.
  • Препарат Solifenacin with vaginal estrogen cream
    Solifenacin (5mg) is anticholinergic. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).
  • Препарат Mirabegron with vaginal estrogen cream
    Mirabegron (25mg) is a beta-3 adrenergic agonist. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).

Первичные конечные точки

  • Short form of Urinary Distress Inventory (UDI-6) [Срок оценки: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
  • Short form of Incontinence Impact Questionnaire (IIQ-7) [Срок оценки: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
  • Overactive Bladder Symptom Score (OABSS) [Срок оценки: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
Вторичные конечные точки (4)
  • Episodes of daily micturition [Срок оценки: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
  • Episodes of daily urgency [Срок оценки: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
  • Episodes of daily incontinence [Срок оценки: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
  • Episodes of daily nocturia [Срок оценки: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]

Критерии участия

Критерии включения

  • Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with anti-muscarinics were enrolled for prospective study.

Критерии исключения

  • Postvoid urine retention before treatment
  • Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension
  • Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • Mackay Memorial Hospital — Taipei

Публикации

  • Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8. PMID 31039103
  • Mueller ER, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Stoelzel M, Yoon SJ, Al-Shukri S, Rechberger T, Gratzke C. Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study. Neurourol Urodyn. 2019 Feb;38(2):779-792. doi: 10.1002/nau.23919. Epub 2019 Jan 15. PMID 30644570
  • Cardozo L, Lose G, McClish D, Versi E. A systematic review of the effects of estrogens for symptoms suggestive of overactive bladder. Acta Obstet Gynecol Scand. 2004 Oct;83(10):892-7. doi: 10.1111/j.0001-6349.2004.00581.x. PMID 15453881

Идентификаторы

NCT: NCT06479720 · 22MMHIS039e-3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗