Impact of uterine fibroids on pelvic floor function
Official title: Prospective Clinical Trial on the Impact of Uterine Fibromatosis Surgery on Pelvic Floor.
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07180524 · Data updated 2026-11-12
This observational study will see if uterine fibroids are linked to urinary and other pelvic floor symptoms in women with symptomatic intramural or subserosal fibroids who are scheduled for hysterectomy or myomectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 35 Years to 55 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | June 30, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | September 18, 2025 |
| Trial ID | NCT07180524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–55 with symptomatic intramural or subserosal uterine fibroids documented by ultrasound who are scheduled for hysterectomy or myomectomy are ideal candidates.
✕Probably not a fit
Pregnant or postmenopausal women, those with suspected malignancy, active cancer, prior chemo/radiotherapy, or a history of pelvic static disorders (and asymptomatic women) are excluded and are unlikely to benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study enrolling women with symptomatic intramural or subserosal uterine fibroids mapped by ultrasound who are scheduled for hysterectomy or myomectomy. Investigators will collect clinical data and symptom information related to urinary, defecatory, and pelvic-perineal dysfunction prior to surgery to estimate prevalence and patterns of symptoms. Patients with suspected malignancy, active tumors, prior chemo/radiotherapy, pregnancy, age under 18 or over 55, or prior pelvic static disorders are excluded. The work is being conducted at a single center (Fondazione IRCCS Policlinico San Matteo, Pavia, Italy) and does not involve an interventional treatment arm.
Why it matters
Potential benefit: If successful, the findings could help clinicians better recognize and manage urinary and pelvic floor symptoms in women with fibroids and inform surgical decision-making.
How similar studies have gone: Previous observational studies have reported variable links between fibroids and urinary symptoms, so while related work exists the relationship is still incompletely characterized.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
Pavia, Pavia, Italy Recruiting
Study contacts
- Study coordinator: Arsenio Spinillo
- Email: spinillo@smatteo.pv.it
- Phone: +39382503267
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.