Post-operative Cognitive Function Following Pelvic Floor Surgery

The aim of this study is to assess cognitive function before and after surgery for pelvic organ prolapse using sensitive tests of various neurocognitive domains.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse

Detailed Description

Post operative cognitive dysfunction has been well described as a relatively common phenomenon with potentially long-lasting detrimental effects. However, there are currently limited data exploring the effects of gynecologic surgery on cognitive function. The population of patients treated surgically for pelvic floor disorders is typically older, and therefore at higher baseline risk for cognitive dysfunction. Therefore, it is of interest to determine the effects of pelvic floor surgery and anesthesia on this patient population. The investigators plan to conduct a prospective cohort study to assess cognitive function before and after pelvic organ prolapse surgery using sensitive tests of memory and other neurocognitive domains. Participants will be women undergoing surgery for pelvic organ prolapse. All participants will undergo cognitive tests at three time points: at their pre-operative clinic appointment, in the hospital the morning after surgery, and at their post-operative clinic appointment. In addition to the neurocognitive tests, patients will undergo a series of questionnaires regarding physical function, frailty, sleep quality, and incontinence symptoms.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women aged 60 and older scheduled to undergo surgery for pelvic organ prolapse at the University of Pennsylvania.

Description

Inclusion Criteria: Women 60 years of age or older who are scheduled to undergo surgery for pelvic organ prolapse.

Exclusion Criteria:

• Women who have a known baseline diagnosis of cognitive dysfunction or central nervous disorder
• A Mini-Mental State Exam (MMSE) score of greater than 24
• Non-english speaking
• Any severe visual or auditory disorder
• Alcoholism or drug dependence

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in episodic memory neurocognitive test scores	Episodic memory will be assessed using the Scene Encoding/Recognition Test	8 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Uduak Andy, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: September 12, 2020
• First Submitted That Met QC Criteria: September 12, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 843178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No