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Major trial to settle best surgery for womb prolapse

NCT ID NCT07566949

Disease control Sponsor: Tampere University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two common surgeries for uterine prolapse (when the womb drops down). About 426 women will be randomly assigned to have either a Manchester procedure or a vaginal hysterectomy. Researchers will track success rates, symptom relief, and quality of life for up to 10 years to see which operation works better.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 426 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2041

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.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Fit for elective vaginal surgery according to standard preoperative assessment * Women aged over 18 years * No previous POP surgery * Symptomatic POP stage 2 or higher, with uterine descent of at least stage 2 (POP-Q point C ≥ minus 1) and with POP-Q point D ≤ minus 1. Patients with concurrent anterior or posterior compartment defects will be included. Exclusion Criteria: * Pregnancy or future plans of pregnancy * Active malignancy of any kind * Contraindications for uterine preservation, i.e. suspected cervical or uterine malignancy, abnormal cervical cytology, abnormal uterine bleeding, a history of endometrial hyperplasia with atypia, or a known hereditary cancer syndrome involving the uterus (e.g., Lynch syndrome). All patients will undergo a clinical examination and ultrasound assessment prior to recruitment. If clinically indicated, a Pap-smear and/or endometrial biopsy will be performed prior to inclusion. * Contraindication to vaginal hysterectomy (e.g. extensive intra-abdominal adhesions) * Patient's preference for uterine removal or preservation * Planned concomitant incontinence procedure * Inability to speak Finnish or Swedish, understand the purpose of the study, or commit to follow-up

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse prolapse of female genital organ Uterine Prolapse

As listed by the trial registrant

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

Pelvic organ prolapse (POP) Pelvic organ prolapse vaginal surgery Uterine prolapse

How to take part

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

  1. The places running it

    6 sites. 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

  • Helsinki University Hospital

    RECRUITING

    Helsinki, Finland

  • Hospital Nova, The Wellbeing Services County of Central Finland

    RECRUITING

    Jyväskylä, Finland

  • Kuopio University Hospital

    RECRUITING

    Kuopio, Finland

  • Oulu University Hospital

    RECRUITING

    Oulu, Finland

  • Tampere University Hospital

    RECRUITING

    Tampere, Finland

  • Turku University Hospital

    RECRUITING

    Turku, Finland

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