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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

112

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Loma Linda University

Investigators

  • 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)

December 1, 2016

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimated)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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