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Clinical Trials/NCT01852422
NCT01852422
Completed
Not Applicable

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

Pop Medical Solutions1 site in 1 countryJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Pop Medical Solutions
Locations
1
Primary Endpoint
Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
October 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Pop Medical Solutions
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Prior pelvic surgery

Outcomes

Primary Outcomes

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

Time Frame: Real time during procedure

Study Sites (1)

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