Robot vs. vaginal surgery for prolapse: which is better? trial stopped early.
NCT ID NCT02800512
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
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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
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116 people
The number who actually took part.
- Started
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Dec 2016
- Finished
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Jun 2026
- Lead sponsor
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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
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Loma Linda University URO/GYN
Loma Linda, California, 92354, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can strength training steady the walk and strengthen the pelvic floor after menopause?
- Can a biological mesh improve pelvic floor surgery?
- Can targeted exercises ease mild pelvic organ prolapse without surgery?
- AI may predict which pelvic floor therapy works best
- Can a small pressure drop make prolapse surgery less painful?
- Can adding mesh support to rectocele surgery boost results?