Clinical Trials Directory

Trials / Completed

CompletedNCT03315715

Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair

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

Status
Completed
Phase
Study type
Observational
Enrollment
17 (actual)
Sponsor
TriHealth Inc. · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Timeline

Start date
2018-03-01
Primary completion
2019-09-12
Completion
2020-05-24
First posted
2017-10-20
Last updated
2020-07-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03315715. Inclusion in this directory is not an endorsement.