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Fibroid surgery showdown: which operation spares your pelvic floor?

NCT ID NCT07180524

Knowledge-focused Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study follows 200 women having surgery for symptomatic uterine fibroids to see how their pelvic floor changes over a year. Half will have a hysterectomy, half a myomectomy. Researchers will measure pelvic floor structure and symptoms at 1, 6, and 12 months after surgery. The goal is to understand which operation better preserves pelvic floor health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors choose the best surgical approach for uterine fibroids to minimize pelvic floor problems.
What could go wrong
This is an observational study, not a treatment trial. It will not prove which surgery is better, only describe differences. Results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with symptomatic uterine fibromatosis and candidates for surgical treatment aged between 40 and 55 years will be consecutively enrolled.

Ages

35 to 55 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fibroma fibromatosis uterine corpus diffuse leiomyomatosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromatosis Pelvic floor dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1

    RECRUITING

    Pavia, Pavia, 27100, Italy

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