Status:
COMPLETED
Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair
Lead Sponsor:
TriHealth Inc.
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
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...
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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 24 2020
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03315715
Start Date
March 1 2018
End Date
May 24 2020
Last Update
July 23 2020
Active Locations (1)
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1
TriHealth - Cincinnati Urogynecology Associates
Cincinnati, Ohio, United States, 45220