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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse

• Study Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel, 65432
    • Western Galilee MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women with pelvic organ prolapse 21-80 years old

Description

Inclusion Criteria:

• age 21-80 years old
• Stage III or higher pelvic prolapse

Exclusion Criteria:

-Prior pelvic surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pelvic prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging	Real time during procedure

Collaborators and Investigators

• Sponsor: Pop Medical Solutions

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 3, 2013
• Study Completion: October 30, 2023

Study Registration Dates

• First Submitted: May 8, 2013
• First Submitted That Met QC Criteria: May 10, 2013
• First Posted (Estimated): May 13, 2013

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: POP protocol 01