Clinical trial NCT03315715: Dynamic Magnetic Resonance Imaging Before and After Vaginal Prolapse Repair
Official title: Dynamic Magnetic Resonance Imaging Following Vaginal Reconstructive Surgery; a Prospective Study to Describe Anatomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in H-line, Dynamic MRI measurement between pre- and post
timeFrame: Before surgery and 12 weeks after surgery
measure: Change in M-line, Dynamic MRI measurement
timeFrame: Before surgery and 12 weeks after surgery
measure: Change in O classification
timeFrame: Before surgery and 12 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth - Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References: