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

Pelvic Organ Prolapse Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852422
• Other study ID #: POP protocol 01
• Status: Completed
• Start date: June 2013
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Pop Medical Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 30, 2023
• Est. primary completion date: August 3, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 21-80 years old

• Stage III or higher pelvic prolapse

Exclusion Criteria:

-Prior pelvic surgery

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
Israel	Western Galilee MC	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Pop Medical Solutions

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging		Real time during procedure