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临床试验/NCT07180524
NCT07180524招募中不适用

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

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
pelvic floor biometry

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

pelvic floor biometry

时间窗: at baseline, immediately after the surgery, 1 month after surgery, 6 and 12 months after surgery

Compare the pelvic floor well-being of patients undergoing total hysterectomy compared to those undergoing myomectomy at 1 month, 6 and 12 months after surgery.

次要结局

  • pelvic floor biometry(at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arsenio Spinillo

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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