Post-operative Cognitive Function Following Pelvic Floor Surgery

• ClinicalTrials.gov Identifier: NCT04554550
• Recruitment Status: Active, not recruiting
• First Posted: September 18, 2020
• Last Update Posted: February 9, 2022
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): Uduak Andy, University of Pennsylvania

Study Description

Brief Summary:

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-operative Cognitive Function Following Pelvic Floor Surgery
• Actual Study Start Date: August 13, 2020
• Estimated Primary Completion Date: February 28, 2022
• Estimated Study Completion Date: March 31, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Change in episodic memory neurocognitive test scores [ Time Frame: 8 weeks ]
   Episodic memory will be assessed using the Scene Encoding/Recognition Test

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

• Principal Investigator: Uduak Andy, MD; University of Pennsylvania

More Information

• Responsible Party: Uduak Andy, Assistant Professor of Obstetrics and Gynecology, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04554550
• Other Study ID Numbers: 843178
• First Posted: September 18, 2020
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prolapse; Pelvic Organ Prolapse; Pathological Conditions, Anatomical