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Идёт набор NCT06197295

Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity

Фаза IV С лечением Urinary Bladder, Overactive Effect of Drug

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: Solifenacin with vaginal estrogen cream, Combination pharmacotherapy.
Кому может быть актуально
Состояния в реестре: Urinary Bladder, Overactive, Effect of Drug. 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 Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity

Обзор

To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.

Подробное описание

Women with detrusor overactivity who were refractory to anti-muscarinics were enrolled for prospective study. Patients were divided into two groups: one receive combined pharmacotherapy with solifenacin and mirabegron, and the other received solifenacin and 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 Solifenacin with vaginal estrogen cream
    Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg
  • Препарат Combination pharmacotherapy
    Solifenacin 5mg and Mirabegron 25mg

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.
  • Women who were on hormone replacement therapy within 3 months were also excluded from the study

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: NCT06197295 · 22MMHIS039e-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗