Cure My Disease

Don't miss your cure!

 Log in / Sign up

Mesh or natural tissue? trial tests best repair for Post-Hysterectomy prolapse

NCT ID NCT02676973

Symptom relief Sponsor: NICHD Pelvic Floor Disorders Network 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Women who develop vaginal vault prolapse after hysterectomy often need surgery, but which operation works best is unclear. This trial randomly assigns 360 women to one of three common repairs: sacral colpopexy using mesh, transvaginal mesh, or native tissue repair. Researchers track whether the prolapse returns or needs retreatment for up to five years, with a longer follow-up extension. The goal is to compare how well mesh repairs hold up against using the body's own tissue.

What this could mean

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

Active substance
Surgical repair using synthetic mesh or the body's own tissue
What this could lead to
If mesh repairs prove superior, this could guide surgeons toward the most durable option for women with vault prolapse. If native tissue works as well, it could spare women the risks of mesh.
What could go wrong
Mesh can erode or cause pain, and native tissue may fail sooner. The trial may not show a clear winner, and 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.

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

360 people

The number who actually took part.

Started

Feb 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

21 years and older

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 age 21 or older 2. Prior total hysterectomy (no cervix present) 3. Prolapse beyond the hymen (defined as Ba, C, or Bp \> 0 cm) 4. Vaginal cuff descent into at least the lower two thirds of the vagina (defined as point C\> -2/3 TVL) 5. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out' 6. Desires surgical treatment for post-hysterectomy vaginal prolapse 7. Available for up to 60 month follow-up Exclusion Criteria: 1. Previous synthetic material or biologic grafts (placed vaginally or abdominally) to augment POP repair including anterior, posterior and/or apical compartments 2. Known previous formal SSLS performed for either uterovaginal or post-hysterectomy vaginal vault prolapse \* 3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess 4. Unresolved chronic pelvic pain-active 5. Prior abdominal or pelvic radiation 6. Contraindication to any of the index surgical procedures * Known Horseshoe Kidney or Pelvic Mass overlying the sacrum * Active diverticular abscess or active diverticulitis * Shortened vaginal length (\<6 cm TVL) * NOTE: * Only documented SSLS will be an exclusion. * Mesh used for only mid-urethral sling will NOT be an exclusion * If prior POP repair is unknown and unable to be documented, subjects will be eligible based on clinician judgment. The investigator will examine and assess for evidence of mesh or graft if no evidence of mesh or graft is present on examination subject remains eligible.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Visceral prolapse are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Cystocele pelvic organ prolapse Uterine Prolapse Visceral Prolapse

As listed by the trial registrant

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

Visceral prolapse

Contacts and locations

Locations

  • Brown/Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02903, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University

    Durham, North Carolina, 27707, United States

  • Kaiser Permanente

    San Diego, California, 92110, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California at San Diego

    San Diego, California, 92037, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19118, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States