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NCT Number: NCT07180524

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

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.

Recruiting

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Key information

Age range

35 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Arsenio Spinillo

CONTACT

[email protected]

+390382503267

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. pelvic floor biometry

    Time frame: 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.

Secondary outcomes

  1. pelvic floor biometry

    Time frame: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery

    Compare pelvic hiatus area, anteroposterior diameter, and transverse diameter over time in patients who underwent total hysterectomy compared to those who underwent myomectomy.

  2. pelvic floor biometry

    Time frame: at baseline, immediately after the surgery, 1 month, 6 and 12 months after surgery

    Compare of the pelvic hiatus over time in patients who underwent total hysterectomy compared to those who underwent myomectomy.

Study contacts

Contact information is provided by the study sponsor or research team.

Arsenio Spinillo

CONTACT

[email protected]

+39382503267

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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