Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair

NCT03315715 | Completed

• 1 other identifier: 17-061
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (3)

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

  The distance from pubic symphysis to the posterior anal canal

  Before surgery and 12 weeks after surgery

• Change in M-line, Dynamic MRI measurement

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

  Before surgery and 12 weeks after surgery

• Change in O classification

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

  Before surgery and 12 weeks after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All women 18 years of age or older, who undergo intraperitoneal vaginal vault suspension, with or without additional concomitant procedures by a physician at Cincinnati Urogynecology Associates, TriHealth for treatment of POP.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth - Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rachel Pauls, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 20, 2017
• Study Start: March 1, 2018
• Primary Completion: September 12, 2019
• Study Completion: May 24, 2020
• Last Updated: July 23, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)