Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair

Sponsor
TriHealth Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT03315715
Collaborator
(none)
17
1
26.8
0.6

Study Details

Study Description

Brief Summary

This study is to describe the impact of vaginal reconstruction, including an intraperitoneal vaginal vault suspension for pelvic organ prolapse (POP) on pelvic anatomy using dynamic magnetic resonance imaging (MRI) of the pelvis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Approximately 1 in 11 women will undergo surgery for POP by age 80 years. POP occurs due to a defect or weakness of the pelvic floor, resulting in the herniation of pelvic organs through the vagina. The goal of surgical interventions has historically been thought to restore normal pelvic anatomy. Restoration of pelvic anatomy has been demonstrated following pelvic reconstructive surgery by way of significantly improved postoperative Pelvic Organ Prolapse Quantification (POPQ) scale measurements. Furthermore, improved POPQ measurements have also been shown to be positively correlated with improved patient satisfaction.

    More recently, attention has turned toward using imaging studies to describe the postoperative anatomical changes seen in pelvic reconstructive surgery. The purpose of this study is to describe the impact of vaginal reconstruction, including an intraperitoneal vaginal vault suspension for POP on pelvic anatomy using dynamic MRI of the pelvis.

    The primary aim is to compare postoperative dynamic pelvic MRI measurements to preoperative measurements in patients who undergo prolapse repair vaginally including anterior, posterior and intraperitoneal vaginal vault suspension repairs for POP.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    17 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Dynamic Magnetic Resonance Imaging Following Vaginal Reconstructive Surgery; a Prospective Study to Describe Anatomy
    Actual Study Start Date :
    Mar 1, 2018
    Actual Primary Completion Date :
    Sep 12, 2019
    Actual Study Completion Date :
    May 24, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Change in H-line, Dynamic MRI measurement between pre- and post [Before surgery and 12 weeks after surgery]

      The distance from pubic symphysis to the posterior anal canal

    2. Change in M-line, Dynamic MRI measurement [Before surgery and 12 weeks after surgery]

      The descent of the levator plate from the pubococyygeal line (PCL)

    3. Change in O classification [Before surgery and 12 weeks after surgery]

      The type of visceral prolapse (cystocele, rectocele, enterocele and the degree beyond the H-line

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adults 18 years of age or older

    • English-speaking

    • Undergoing anterior, posterior and intraperitoneal vaginal vault suspension by a physician at Cincinnati Urogynecology Associates, TriHealth for the treatment of symptomatic POP

    • Concomitant procedures such as hysterectomy, suburethral sling, bilateral salpingectomy or salpingooophorectomy

    • Willingness to participate in study

    Exclusion Criteria:
    • Unwillingness to participate in the study

    • Pregnancy

    • Contraindication to pelvic MRI, such as a metal implanted device (excluding titanium) or claustrophobia

    • Previous surgery for apical prolapse such as sacrocolpopexy or vaginal vault suspension, or transvaginal mesh for prolapse

    • Physical or mental impairment that would affect the subject's ability to complete the dynamic MRI, including patient's with dementia or those who have impaired mobility

    • Known findings that may distort pelvic anatomy, such as a pelvic mass, congenital anomaly, or history of pelvic radiation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TriHealth - Cincinnati Urogynecology Associates Cincinnati Ohio United States 45220

    Sponsors and Collaborators

    • TriHealth Inc.

    Investigators

    • Principal Investigator: Rachel Pauls, MD, TriHealth - Cincinnati Urogynecology Associates

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TriHealth Inc.
    ClinicalTrials.gov Identifier:
    NCT03315715
    Other Study ID Numbers:
    • 17-061
    First Posted:
    Oct 20, 2017
    Last Update Posted:
    Jul 23, 2020
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 23, 2020