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

Recruiting now

Conditions studied: Pelvic Floor Dysfunction, Fibromatosis

In brief

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.

Key facts

Study ID

NCT07180524

Run by

Fondazione IRCCS Policlinico San Matteo di Pavia

People needed

200

Starts

2024-06-30

Expected to finish

2029-12-31

Last updated by the study team

2025-09-18

Who can join

Age: 35 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1 — Pavia, Pavia, Italy (enrolling)

Full record on ClinicalTrials.gov

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