Status:
COMPLETED
The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new stud...
Detailed Description
The goal of this long-term follow-up study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery and to compare the success and complication rates of the two ...
Eligibility Criteria
Inclusion
- 1\. Completion of the Year 2 OPTIMAL in-person visit
Exclusion
- Inability to provide informed consent.
- Subjects who are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation) at the time of enrollment into E-OPTIMAL. Note: Subjects unable to return for annual visits are not excluded as they can participate in the telephone interview. However, every attempt will be made to encourage in-person participation.
- Criteria for termination of participation:
- (Due to evidence or likelihood that the subject can no longer consent for herself)
- Subjects 75 years and older that fail the telephone mini-mental status examination. If the participant gets 5 or more of the 10 items "incorrect" the interviewer says "thank you very much for your time, that completes the interview for today." In other words, the interviewer in no way implies to the participant that they did not "pass" a test to continue. The interviewer contacts the appropriate site coordinator immediately after the interview to let them know of the outcome.
- Subjects younger than 75 who appear to have cognitive deficits during the quality of life telephone interview will be administered the mini-mental status examination; those who fail will be excluded from further participation. (Proxy respondents will not be used.) Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
- Subjects who become long-term residents of a skilled nursing facility.
- Withdrawal of consent. Verbal assent will be obtained prior to each telephone interview and each in-person visit.
- Note: Subjects that are unable to complete telephone interviews (for example, because of hearing loss) may complete the interview portion of the survey in person, either at the site or in the home.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT01166373
Start Date
April 1 2010
End Date
July 1 2016
Last Update
September 28 2020
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama
Birmingham, Alabama, United States, 35249
2
University of California, San Diego Medical Center
La Jolla, California, United States, 92037
3
Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
Duke University
Durham, North Carolina, United States, 27710