Prolift Versus IVS for Pelvic Floor Prolapse

June 19, 2014 updated by: Western Galilee Hospital-Nahariya

Postoperative Comparison Between Posterior Prolift Mesh Placement and Posterior IVS Sling Placement

  • Women who underwent mesh or sling procedures to correct pelvic organ prolapse will be enrolled.
  • Their data will be collected from the files.
  • Comparison between two groups will be carried our: Those who underwent a posterior IVS and those who underwent posterior prolift procedure.
  • The data will be obtained by questionaires by a telephone interview by a physician who did not participate in the surgery.
  • Follow-up physical examination data will also be obtained.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

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

  • Israel
      • Nahariya, Israel
        • Department of Obstetrics and Gynecology, Western Galilee Hospital
      • Rishon Lezion, Israel
        • Clinics of Dr Neuman

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

Description

Inclusion Criteria:

  • Women who previously underwent surgery for pelvic floor prolapse at least a year before

Exclusion Criteria:

  • Women who did not have surgery 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

Cohorts and Interventions

Group / Cohort
Pelvic floor prolapse
Those who underwent prolift and those who underwent IVS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

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 (Anticipated)

January 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

June 26, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920090041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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