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TerminatedNCT02800512Updated Jun 16, 2026

SCP vs HUSLS for Pelvic Organ Prolapse Repair

An interventional study of Robotic sacrocolpopexy and high uterosacral ligament suspension in Pelvic Organ Prolapse, Cystocele and Rectocele, sponsored by Loma Linda University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Primary conditionCystoceleRegistry: Pelvic Organ ProlapseReclassifiedWhy we changed it
Registry
Pelvic Organ Prolapse — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cystocele
Why
  1. The study's listed conditions name Cystocele, a narrower term within Pelvic Organ Prolapse.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Loma Linda University · Not applicable, Interventional, and Basic science

Why this study was terminated
Terminated by IRB
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
Female
01

Study summary

The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.

Read the detailed description

To compare the effectiveness of Robotic Sacrocolpopexy versus vaginal High Uterosacral Ligament Suspension for treatment of pelvic organ prolapse. Both surgeries are standard of care and are equally and widely used throughout the country with well known safety and efficacy.

02

Conditions studied

  • Pelvic Organ Prolapse
  • Cystocele
  • Rectocele
  • Enterocele

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Keywords

  • pelvic organ prolapse
  • cystocele
  • rectocele
  • enterocele
03

In context

Cystocele Reclassified

71 studies on the registry are indexed under Cystocele; 5 are open to participants now.

This study's enrollment of 116 is above the median of 75 across 46 interventional studies indexed under Cystocele.

Browse Cystocele studies →

Lead sponsor

Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.

Browse Loma Linda University studies →

Compared within Cystocele, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pelvic Organ Prolapse. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 Years of age or older
  • Signed
  • Symptomatic pelvic organ prolapse,
  • Willing and able to complete all study visit

Exclusion criteria

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

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Active comparator
    Sacrocolpopexy

    Robotic sacrocolpopexy

    Procedure: Robotic sacrocolpopexy

  • Active comparator
    HUSLS

    Vaginal high uterosacral ligament suspension

    Procedure: high uterosacral ligament suspension

Interventions

  • ProcedureRobotic sacrocolpopexy

    Sacrocolpopexy is a procedure to surgically correct vaginal vault prolapse where mesh is used to hold the vagina in the correct anatomical position. Robotic assistance is a minimally invasive method to perform this abdominal procedure.

    Also known as: R-SCP

  • Procedurehigh uterosacral ligament suspension

    Utilizing uterosacral ligaments to support the vaginal cuff can be performed vaginally-by passing sutures bilaterally through the uterosacral ligaments. near the level of the ischial spine. HUSLS is a vaginal minimally invasive procedure for POP.

    Also known as: HUSLS

06

What researchers measure

Primary outcomes

  1. Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively

    Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

    Time frame: 3 month post operative

  2. Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively

    Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

    Time frame: 6 month post operative

  3. Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively

    Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.

    Time frame: 12 month post operative

Secondary outcomes

  1. questionnaires PFDI-7

    Subject will fill out the PFDI-7 questionnaire

    Time frame: 6 month post operative

  2. questionnaires PFDI-7

    Subject will fill out the PFDI-7 questionnaire

    Time frame: 12 month post operative

  3. questionnaires PFIQ-20

    Subject will fill out the PFIQ-20 questionnaire

    Time frame: 6 month post operative

  4. questionnaires PFIQ-20

    Subject will fill out the PFIQ-20 questionnaire

    Time frame: 12 month post operative

  5. questionnaires PISQ-12

    Subject will fill out the PISQ-12 questionnaire

    Time frame: 6 month post operative

  6. questionnaires PISQ-12

    Subject will fill out the PISQ-12 questionnaire

    Time frame: 12 month post operative

  7. questionnaires PGI-I

    Subject will fill out the PGI-I

    Time frame: 6 month post operative

  8. questionnaires PGI-I

    Subject will fill out the PGI-I

    Time frame: 12 month post operative

07

Study locations

1 site
  • Loma Linda University URO/GYN
    Loma Linda, California 92354, United States
08

References and documents

Publications

  • Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J Urol. 2006 Aug;176(2):655-9. doi: 10.1016/j.juro.2006.03.040. PubMed 16813916 ↗
  • Margulies RU, Rogers MA, Morgan DM. Outcomes of transvaginal uterosacral ligament suspension: systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Feb;202(2):124-34. doi: 10.1016/j.ajog.2009.07.052. PubMed 20113690 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2016 to primary completion in Jun 2026, 113 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2016
First posted
Jun 15, 2016
StartActual
Dec 27, 2016
Primary completionActual
Jun 10, 2026
CompletionActual
Jun 10, 2026
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02800512
Lead sponsor
Loma Linda University
Responsible party
Sponsor
First posted
Jun 15, 2016
Start date
Dec 27, 2016
Primary completion
Jun 10, 2026
Completion
Jun 10, 2026
Last update
Jun 16, 2026

Study contacts

Sam Siddighi
principal investigator · Loma Linda University Health Care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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