Pelvic Organ ProlapseNCT02800512
SCP vs HUSLS for Pelvic Organ Prolapse Repair
A study testing Robotic sacrocolpopexy and high uterosacral ligament suspension in people with Pelvic Organ Prolapse and Cystocele, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Cystocele, Rectocele
- What is being tested?
- Robotic sacrocolpopexy and high uterosacral ligament suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2016to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years of age or older
- Signed Informed Consent
- Symptomatic pelvic organ prolapse,
- Willing and able to complete all study visit
Who cannot join
- Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery),
- Dementia or considered unable to complete questionnaires
- Hx of Alzheimer Disease
- Hx multiple strokes or other neurologic condition
- Caregiver states the subject is unable to complete
- MDs opinion
Show all 26Show fewer
- Inability to complete follow up visits due to transportation issues
- No access to transportation (ie. does not have vehicle)
- Live > 2 hours from LLUH
- Does not have financial means
- Congenital anomalies
- Bladder Exstrophy
- Connective tissue disease
- Neovaginal prolapse
- Prolapse of sex change vagina
- Chronic pelvic pain
- > 6 months of pelvic pain of undetermined origin
- not cyclic pain (eg. period pain or dysmenorrhea)
- Patient has comorbidities of CPP
- Fibromyalgia
- Interstitial cystitis
- Vulvodynia
- Contraindications to Mesh,
- Opposition to the use mesh (ie. due to religious beliefs)
- History of mesh complications in past
- Pregnant or planning to become pregnant during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University URO/GYN
Loma Linda, California, 92354
About this study
Official title: Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial
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.
- Conditions
- Pelvic Organ Prolapse, Cystocele, Rectocele, Enterocele
- Being tested
- Robotic sacrocolpopexy, high uterosacral ligament suspension
- Keywords
- pelvic organ prolapse, cystocele, rectocele, enterocele
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele, Rectocele, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic sacrocolpopexyProcedure or surgery
Also called R-SCP
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.
high uterosacral ligament suspensionProcedure or surgery
Also called HUSLS
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.
| Study group | Role | What they receive |
|---|---|---|
| Sacrocolpopexy | Active comparator | Robotic sacrocolpopexy Receives: Procedure: Robotic sacrocolpopexy |
| HUSLS | Active comparator | Vaginal high uterosacral ligament suspension Receives: Procedure: high uterosacral ligament suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month post operative
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.
Measured: 6 month post operative
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.
Measured: 12 month post operative
Secondary outcomes (8)
questionnaires PFDI-7
Subject will fill out the PFDI-7 questionnaire
Measured: 6 month post operative
questionnaires PFDI-7
Subject will fill out the PFDI-7 questionnaire
Measured: 12 month post operative
questionnaires PFIQ-20
Subject will fill out the PFIQ-20 questionnaire
Measured: 6 month post operative
questionnaires PFIQ-20
Subject will fill out the PFIQ-20 questionnaire
Measured: 12 month post operative
questionnaires PISQ-12
Subject will fill out the PISQ-12 questionnaire
Measured: 6 month post operative
questionnaires PISQ-12
Subject will fill out the PISQ-12 questionnaire
Measured: 12 month post operative
questionnaires PGI-I
Subject will fill out the PGI-I
Measured: 6 month post operative
questionnaires PGI-I
Subject will fill out the PGI-I
Measured: 12 month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start27 Dec 2016
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Why it stopped: Terminated by IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Siddighi, Principal investigator, Loma Linda University Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800512
- Sponsor's protocol ID
- 5160158
- Status last verified
- Jun 2026
- First submitted
- 26 Apr 2016
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 16813916Margulies 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02800512
- Acronym / sponsor ID
- 5160158
- Conditions
- Pelvic Organ Prolapse, Cystocele, Rectocele, Enterocele
- Keywords
- pelvic organ prolapse, cystocele, rectocele, enterocele
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by IRB
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacrocolpopexy | Active comparator | Procedure: Robotic sacrocolpopexyRobotic sacrocolpopexy |
| HUSLS | Active comparator | Procedure: high uterosacral ligament suspensionVaginal high uterosacral ligament suspension |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 Years of age or older
- Signed Informed Consent
- Symptomatic pelvic organ prolapse,
- Willing and able to complete all study visit
Key exclusion criteria (26 listed)
- Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery),
- Dementia or considered unable to complete questionnaires
- Inability to complete follow up visits due to transportation issues
- Congenital anomalies
- Chronic pelvic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic sacrocolpopexyAlso: R-SCPSacrocolpopexy 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. | Procedure or surgery | Sacrocolpopexy |
| high uterosacral ligament suspensionAlso: HUSLSUtilizing 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. | Procedure or surgery | HUSLS |
Primary outcome
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
Time frame: 3 month post operative
Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
Time frame: 6 month post operative
Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
Time frame: 12 month post operative
Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.
8 secondary outcomes
questionnaires PFDI-7
Time frame: 6 month post operative
questionnaires PFDI-7
Time frame: 12 month post operative
questionnaires PFIQ-20
Time frame: 6 month post operative
questionnaires PFIQ-20
Time frame: 12 month post operative
questionnaires PISQ-12
Time frame: 6 month post operative
questionnaires PISQ-12
Time frame: 12 month post operative
questionnaires PGI-I
Time frame: 6 month post operative
questionnaires PGI-I
Time frame: 12 month post operative
Results and safety
The study was stopped early (reason given: Terminated by IRB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 16813916Elliott 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.
- Background: PubMed 20113690Margulies 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.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Siddighi principal investigator
Loma Linda University Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic sacrocolpopexy and high uterosacral ligament suspension in people with Pelvic Organ Prolapse and Cystocele, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated by IRB). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively (time frame: 3 month post operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800512, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.