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Location and Anatomic Characterization of the Sacrospinous Ligaments in Women With Pelvic Organ Prolapse

Sponsor
Pop Medical Solutions (Industry)
Overall Status
Completed
CT.gov ID
NCT01852422
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction. Despite its common occurrence, the cause of POP remains largely unknown. Prolapse is thought to be caused by direct injury to the levator ani (LA) muscle, denervation of the pelvic floor musculature, or fascial damage incurred during childbirth trauma. The sacrospinous ligaments are commonly employed surgical structures employed to repair vaginal prolapse. Despite the frequent use of these structures in prolapse surgery, there is a paucity of information regarding the identification of these structures outside of surgical dissection. Furthermore, there is no published data describing the relative distances between the apex of the vagina and these ligaments in women with prolapse. Recent developments in imaging have enabled the identification of the distal subdivisions of the levator ani, classifying as: pubovaginalis, puboanalis, and the puboperinealis as the subdivisions of the pubovisceralis. The visualization of these structures is possible using a 3D ultrasound technique (BK medical, Wilmington, MA), that has been validated in cadavers and in live humans, with excellent interrater reliability. The investigators propose to use this technology to explore the anatomy of the sacrospinous ligaments.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Jun 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Pelvic prolapse

    Outcome Measures

    Primary Outcome Measures

    1. Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging [Real time during procedure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age 21-80 years old

    • Stage III or higher pelvic prolapse

    Exclusion Criteria:

    -Prior pelvic surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Western Galilee MC Nahariya Israel 65432

    Sponsors and Collaborators

    • Pop Medical Solutions

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pop Medical Solutions
    ClinicalTrials.gov Identifier:
    NCT01852422
    Other Study ID Numbers:
    • POP protocol 01
    First Posted:
    May 13, 2013
    Last Update Posted:
    Oct 29, 2013
    Last Verified:
    Oct 1, 2013
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Oct 29, 2013