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

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ClinicalTrials.gov Identifier: NCT01852422
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Pop Medical Solutions

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.

Condition or disease
Pelvic Organ Prolapse

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Study Type : Observational
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2013
Actual Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Pelvic prolapse



Primary Outcome Measures :
  1. Unequivocal identification of the sacrospinous ligaments, in real time, by ultrasound imaging [ Time Frame: Real time during procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with pelvic organ prolapse 21-80 years old
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-Prior pelvic surgery


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852422


Locations
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Israel
Western Galilee MC
Nahariya, Israel, 65432
Sponsors and Collaborators
Pop Medical Solutions
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Responsible Party: Pop Medical Solutions
ClinicalTrials.gov Identifier: NCT01852422    
Other Study ID Numbers: POP protocol 01
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical