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.