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

NCT01852422 | Completed

• 1 other identifier: POP protocol 01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging

  Real time during procedure

Study Arms (1)

Pelvic prolapse

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with pelvic organ prolapse 21-80 years old

You may qualify if:

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

You may not qualify if:

• Prior pelvic surgery

Sponsors & Collaborators

• Pop Medical Solutions: lead

Study Sites (1)

Western Galilee MC

Nahariya, 65432, Israel

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 13, 2013
• Study Start: June 1, 2013
• Primary Completion: August 3, 2013
• Study Completion: October 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

IL (1)