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Completed

NCT Number: NCT03315715

Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

TriHealth - Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in H-line, Dynamic MRI measurement between pre- and post

    Time frame: 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

    Time frame: Before surgery and 12 weeks after surgery

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

  3. Change in O classification

    Time frame: Before surgery and 12 weeks after surgery

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

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Dynamic Magnetic Resonance Imaging Following Vaginal Reconstructive Surgery; a Prospective Study to Describe Anatomy

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 20, 2017
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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