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A Novel Assay for Predicting Surgical Outcomes in Pelvic Organ Prolapse

NCT03534830 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2021-10-07

No results posted yet for this study

Summary

The research objective of this proposal is to investigate the clinical utility and validity of eLASV as a personalized marker for women's individual risk of recurrence for pelvic organ prolapse following advanced surgical procedures. Estimated levator ani subtended volume (eLASV) is a reproducible magnetic resonance image of the female pelvis that objectively quantifies the integrity of the pelvic floor levator ani muscles. A woman's levator ani muscle anatomical shape is unique to her as a result of her own individual lifetime risk for development of pelvic floor dysfunction. The novelty of eLASV as a measurement of muscle integrity, separates it methodology from the solitary of diagnosing partial trauma or defects as previously published within the literature. eLASV measurements have the potential to identify women at increased risk for surgical failure and may be used as a prognostic tool to aid in future counseling and stratification of patients into surgical options for treatment of pelvic organ prolapse.

Conditions

  • Prolapse Genital

Interventions

DIAGNOSTIC_TEST

MRI

pre-operative MRI to be performed on all patients and then based on the imaging studies, the patient will be divided into the two comparative cohorts

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2020-12-31
Completion
2021-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534830 on ClinicalTrials.gov