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Prolapse surgery showdown: which procedure wins?

NCT ID NCT05063331

Disease control Sponsor: University Hospitals Cleveland Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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: a minimally invasive sacrocolpopexy and a vaginal hysterectomy with uterosacral ligament suspension. Researchers will track 300 women to see which surgery has fewer failures and complications from the patient's perspective. The goal is to help women and their doctors choose the best option.

What this could mean

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

Active substance
surgery (minimally invasive sacrocolpopexy or vaginal hysterectomy with uterosacral ligament suspension)
What this could lead to
If this trial succeeds, it could help doctors and patients choose the better surgical option for treating uterine prolapse, leading to fewer failures and complications.
What could go wrong
This is an observational comparison, not a blinded trial, so results may be influenced by patient or surgeon preferences. Both surgeries have risks like pain, infection, or prolapse recurrence.

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 300 people

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

Started

Dec 2021

Expected to finish

May 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.

Ages

18 to 80 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: 1. Women ≥ 18 years of age and ≤ 80 years of age 2. Have diagnosis of symptomatic uterovaginal prolapse 3. Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician 4. Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) Exclusion Criteria: 1. Patients who wish to undergo uterine sparing procedures 2. Body mass index BMI) \> 50 3. Previous hysterectomy or prior uterovaginal surgery 4. Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident 5. Chronic indwelling urinary catheter 6. Urinary diversion of any type 7. Any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results 8. Unable to speak, read, understand English

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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.

Uterine prolapse

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University

    Durham, North Carolina, 27707, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Northwestern Medicine

    Chicago, Illinois, 60611, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Pittsburgh, UPMC Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213, United States

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