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OpenTrials
Completed

NCT Number: NCT01852422

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.

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Key information

Age range

21 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Western Galilee MC

Nahariya, 65432, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-Prior pelvic surgery

Treatment and study plan

Primary outcomes

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

    Time frame: Real time during procedure

Sponsors and collaborators

Lead sponsor

Pop Medical Solutions

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2023
First posted
May 13, 2013
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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