A Novel Assay for Predicting Surgical Outcomes in Pelvic Organ Prolapse

NCT03534830 | Completed

• 1 other identifier: 00031263
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Surgical failure after apical prolapse repair

  Surgical failure will be a single composite outcome that will be defined by any of the following information: presence of anatomic bulge beyond the hymen (within any compartment: anterior, posterior, or apical), sensation of a symptomatic vaginal bulge, or the need for repeat treatment for prolapse via pessary or surgery

  one year

Secondary Outcomes (3)

• Repeatability of measurement

  one year

• Reliability of measurement-inter observer

  one year

• Reliability of measurement intra observer

  one year

Study Arms (2)

eLASV > 38.5

exposed group of patients with an eLASV at or above 38.5 on a pre-operative MRI.

Diagnostic Test: MRI

eLASV < 38.5

non-exposed group of patients with an eLASV less than 38.5 of pre-operative MRIs

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

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

eLASV < 38.5; eLASV > 38.5

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit 50 women total with symptomatic stage III pelvic organ prolapse who elect to proceed with surgical intervention within the Division of Urogynecology at University of South Florida (USF) Department of Obstetrics and Gynecology.

You may qualify if:

• Greater than or equal to 18 years old
• English speaking
• Willing to sign an informed consent
• Stage III pelvic organ prolapse

You may not qualify if:

• Inability to undergo a pelvic MRI
• Having a different apical suspension procedure for pelvic organ prolapse

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33606, United States

Location

Related Publications (1)

• Wyman AM, Salemi JL, Lai-Yuen S, Greene KA, Bassaly R, Kedar R, Hoyte L. Estimated Levator Ani Subtended Volume: A Predictive Biomarker for Surgical Outcomes Following Native Tissue Apical Repair. Female Pelvic Med Reconstr Surg. 2022 Jun 1;28(6):385-390. doi: 10.1097/SPV.0000000000001142. Epub 2022 Mar 4.

  PMID: 35234178 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: May 23, 2018
• Study Start: February 2, 2018
• Primary Completion: December 31, 2020
• Study Completion: January 1, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Locations

US (1)