Actively Recruiting

Age: 35Years - 55Years
FEMALE
Healthy Volunteers
ID07180524

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

Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-09-18

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Uterine fibromatosis, a common gynecological condition affecting about 25-30% of women during their fertile years, is associated with symptoms like heavy menstrual bleeding, pelvic pain, and urinary or bowel issues. Risk factors include age, family history, and ethnicity, while multiple pregnancies, older age at pregnancy, and smoking may offer some protection. Despite many cases being symptom-free, uterine fibroids are a leading cause of hysterectomy for benign conditions, and their impact on urinary and pelvic floor symptoms remains unclear. This research observes women with symptomatic uterine fibromatosis who are scheduled for either hysterectomy or myomectomy surgery. The study evaluates how these surgical treatments affect pelvic floor function by measuring pelvic floor biometry at multiple points: before surgery, immediately after, and at 1, 6, and 12 months following surgery. The goal is to better understand the relationship between fibroid treatment and pelvic floor symptoms. Participants will undergo ultrasound mapping of their fibroids before surgery. Researchers will monitor pelvic floor health through repeated biometry assessments over the year following surgery. This study tracks changes in pelvic floor function over time to assess the impact of the surgical approach chosen. The total participation period lasts up to 12 months post-surgery, with careful monitoring of pelvic floor outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 35Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic uterine fibromatosis with intramural and/or subserosal myomas identified by ultrasound and topographically mapped
  • Patients with scheduled hysterectomy or myomectomy
Not Eligible

You will not qualify if you...

  • Suspicion of malignant lesion
  • Active tumors
  • Previous history of chemotherapy or radiotherapy
  • Pregnancy
  • Age under 18 years or over 55 years (postmenopause)
  • History of pelvic static disorders prior to surgery

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediately after

Participants undergo hysterectomy or myomectomy surgery with immediate post-operative assessments.

1 visit (in-person) on surgery day

Post-operative Follow-up

Duration - 12 months

Participants have follow-up visits to assess pelvic floor biometry after surgery.

Visits immediately after surgery, at 1 month, 6 months, and 12 months after surgery

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1

Pavia, Pavia, Italy, 27100

Actively Recruiting

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Research Team

A

Arsenio Spinillo

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial