- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01392417
Anterior Prolift Versus Posterior Prolift for Pelvic Floor Prolapse
July 2, 2014 updated by: menahem neuman, Western Galilee Hospital-Nahariya
Women who had surgery for pelvic floor prolapse underwent surgery by anterior Prolift or Posterior prolift at least a year after the surgery.
The data from the charts and from telephone conversations with the patients will be entered to a database. Physical examination data will also be incorporated.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
140
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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Nahariya, Israel
- Department of Obstetrics and Gynecology, Western Galilee Hospital
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Tel Aviv, Israel
- Clinics of Dr Neuman
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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
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with pelvic floor prolapse who underwent surgery with Prolift
Description
Inclusion Criteria:
- Women who underwent surgery by anterior Prolift or posterior Prolift for pelvic floor prolapse
Exclusion Criteria:
- Women who did not have surgery by Prolift for pelvic floor prolapse
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
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of pelvic floor prolapse
Time Frame: One year after surgery
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We will question the women if they have a feeling of a mass protruding through the labia.
Physical examination data will also be incorporated.
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One year after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
February 1, 2009
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
June 29, 2011
First Submitted That Met QC Criteria
July 10, 2011
First Posted (Estimate)
July 12, 2011
Study Record Updates
Last Update Posted (Estimate)
July 3, 2014
Last Update Submitted That Met QC Criteria
July 2, 2014
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 920090043
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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