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Robot vs. vaginal surgery for prolapse: which is better? trial stopped early.

NCT ID NCT02800512

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 compared two surgical repairs for pelvic organ prolapse (when organs like the bladder or uterus drop into the vagina). One method uses a robot to place mesh inside the abdomen; the other uses stitches through the vagina to tighten natural ligaments. The trial enrolled 116 women but was terminated early, so firm conclusions are limited. The goal was to see which approach provides better support and fewer symptoms after surgery.

What this could mean

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

Active substance
surgical procedure (robotic sacrocolpopexy with mesh or high uterosacral ligament suspension)
What this could lead to
If one method proves better, it could guide surgeons on which approach offers longer-lasting prolapse repair with fewer complications.
What could go wrong
The trial was terminated early, so results are limited. Neither surgery eliminates the risk of prolapse returning, and mesh procedures carry rare but serious risks.

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

116 people

The number who actually took part.

Started

Dec 2016

Finished

Jun 2026

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: * 18 Years of age or older * Signed Informed Consent * Symptomatic pelvic organ prolapse, * Willing and able to complete all study visit Exclusion Criteria: * Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery), * Dementia or considered unable to complete questionnaires 1. Hx of Alzheimer Disease 2. Hx multiple strokes or other neurologic condition 3. Caregiver states the subject is unable to complete 4. MDs opinion * Inability to complete follow up visits due to transportation issues 1. No access to transportation (ie. does not have vehicle) 2. Live \> 2 hours from LLUH 3. Does not have financial means * Congenital anomalies 1. Bladder Exstrophy 2. Connective tissue disease 3. Neovaginal prolapse 4. Prolapse of sex change vagina * Chronic pelvic pain 1. \> 6 months of pelvic pain of undetermined origin 2. not cyclic pain (eg. period pain or dysmenorrhea) 3. Patient has comorbidities of CPP 4. Fibromyalgia 5. Interstitial cystitis 6. Vulvodynia * Contraindications to Mesh, 1. Opposition to the use mesh (ie. due to religious beliefs) 2. History of mesh complications in past * Pregnant or planning to become pregnant during the study period.

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Conditions

The condition(s) this trial relates to.

Cystocele Hernia pelvic organ prolapse Rectocele

As listed by the trial registrant

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

Contacts and locations

Locations

  • Loma Linda University URO/GYN

    Loma Linda, California, 92354, United States

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