Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315715
• Other study ID #: 17-061
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: May 24, 2020

Study information

• Verified date: November 2019
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 24, 2020
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	TriHealth - Cincinnati Urogynecology Associates	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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