- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04554550
Post-operative Cognitive Function Following Pelvic Floor Surgery
July 21, 2022 updated by: Uduak Andy, University of Pennsylvania
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in episodic memory neurocognitive test scores
Time Frame: 8 weeks
|
Episodic memory will be assessed using the Scene Encoding/Recognition Test
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Uduak Andy, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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