SCP vs HUSLS for Pelvic Organ Prolapse Repair

January 2, 2025 updated by: Loma Linda University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Christine Cota
  • Phone Number: 9095582595
  • Email: ccota@llu.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sacrocolpopexy
Robotic sacrocolpopexy
Procedure: Robotic 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.
Other Names:
  • R-SCP
Active Comparator: HUSLS
Vaginal high uterosacral ligament suspension
Procedure: high 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.
Other Names:
  • HUSLS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 month post operative
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.
6 month post operative
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.
12 month post operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
questionnaires PFDI-7
Time Frame: 6 month post operative
Subject will fill out the PFDI-7 questionnaire
6 month post operative
questionnaires PFDI-7
Time Frame: 12 month post operative
Subject will fill out the PFDI-7 questionnaire
12 month post operative
questionnaires PFIQ-20
Time Frame: 6 month post operative
Subject will fill out the PFIQ-20 questionnaire
6 month post operative
questionnaires PFIQ-20
Time Frame: 12 month post operative
Subject will fill out the PFIQ-20 questionnaire
12 month post operative
questionnaires PISQ-12
Time Frame: 6 month post operative
Subject will fill out the PISQ-12 questionnaire
6 month post operative
questionnaires PISQ-12
Time Frame: 12 month post operative
Subject will fill out the PISQ-12 questionnaire
12 month post operative
questionnaires PGI-I
Time Frame: 6 month post operative
Subject will fill out the PGI-I
6 month post operative
questionnaires PGI-I
Time Frame: 12 month post operative
Subject will fill out the PGI-I
12 month post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loma Linda University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sam Siddighi, Loma Linda University Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5160158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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