NCT04554550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

1.5 years

First QC Date

September 12, 2020

Last Update Submit

July 21, 2022

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Change in episodic memory neurocognitive test scores

    Episodic memory will be assessed using the Scene Encoding/Recognition Test

    8 weeks

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Uduak Andy, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 12, 2020

First Posted

September 18, 2020

Study Start

August 13, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)