Меню
Идёт набор NCT07180524

Prospective Clinical Trial on the Impact of Uterine Firomatosis on Pelvic Floor.

— Наблюдательное Pelvic Floor Dysfunction Fibromatosis

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pelvic Floor Dysfunction, Fibromatosis. Базовые параметры: 35 лет — 55 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective Clinical Trial on the Impact of Uterine Fibromatosis Surgery on Pelvic Floor.

Обзор

Uterine fibromatosis is one of the most frequent gynecological conditions; in fact, uterine fibroids involve approximately 25-30% of women during the fertile period. Risk factors for the development of this pathology include age, family history and ethnicity. Multiparity, advanced age for pregnancy and smoking appear to be protective factors. Myomas are responsible for numerous symptoms reported by patients, such as menometrorrhagia, pelvic pain and urinary and/or deficatory symptoms. Although myomas are asymptomatic in almost 50% of cases, they represent the first cause of hysterectomy for benign pathologies (about 2/3 of cases). Urinary symptoms associated with myomas are rarely studied in patients with symptomatic uterine fibromatosis; therefore the impact that this pathology has on the symptoms related to pelvic-perineal dysfunction and what their prevalence is is not well known at present. The prevalence of urinary symptoms in women with uterine myomas is highly variable based on literature data and the studies considered; in fact, the most frequently reported urinary symptoms are urinary urgency (31-59%), dysuria (4-36%) and stress urinary incontinence (20-80%). Furthermore, there is currently no unanimous agreement between the topography and size of myomas and related urinary and pelvic symptoms. The type of treatment varies from single or multiple myomectomy to hysterectomy performed laparoscopically or laparotomy. The choice of surgical approach depends on the number, size and position of myomas. To date, few studies have evaluated the impact of the type of surgical treatment on pelvic floor symptoms. In fact, although hysterectomy is considered a risk factor for the onset of pelvic floor disorders, removal of the uterus can sometimes improve urinary symptoms. However, some authors report, equally, a significant improvement in urinary symptoms after myomectomy. Further studies are needed to clarify the impact of myoma treatment on urinary symptoms.

Первичные конечные точки

  • pelvic floor biometry [Срок оценки: at baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgery]
Вторичные конечные точки (2)
  • pelvic floor biometry [Срок оценки: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery]
  • pelvic floor biometry [Срок оценки: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery]

Критерии участия

Критерии включения

  • Symptomatic uterine fibromatosis with intramural and/or subserosal myomas identified by ultrasound and topographically mapped
  • Patients with scheduled hysterectomy or myomectomy

Критерии исключения

  • suspicion of malignant lesion.
  • active tumors
  • previous history of chemotherapy or radiotherapy
  • pregnancy
  • age <18 years or >55 years (postmenopause)
  • history of pelvic static disorders prior to surgery

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1 — Pavia

Публикации

  • Shaffer RK, Dobberfuhl AD, Vu KN, Fast AM, Dababou S, Marrocchio C, Lum DA, Hovsepian DM, Ghanouni P, Chen B. Are fibroid and bony pelvis characteristics associated with urinary and pelvic symptom severity? Am J Obstet Gynecol. 2019 May;220(5):471.e1-471.e11. doi: 10.1016/j.ajog.2019.01.230. Epub 2019 Jan 31. PMID 30711512
  • Dagur G, Suh Y, Warren K, Singh N, Fitzgerald J, Khan SA. Urological complications of uterine leiomyoma: a review of literature. Int Urol Nephrol. 2016 Jun;48(6):941-8. doi: 10.1007/s11255-016-1248-5. Epub 2016 Feb 27. PMID 26922066

Идентификаторы

NCT: NCT07180524 · FIBROPELV

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗