Prolift Versus IVS for Pelvic Floor Prolapse

This study is currently recruiting participants.

Verified July 2011 by Western Galilee Hospital-Nahariya

Sponsor:

Information provided by:

Western Galilee Hospital-Nahariya

ClinicalTrials.gov Identifier:

NCT01383291

First received: June 26, 2011

Last updated: July 23, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 26, 2011

Last Updated Date

July 23, 2011

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01383291 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prolift Versus IVS for Pelvic Floor Prolapse

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Women with pelvic floor prolapse

Condition ^ICMJE

Pelvic Floor Prolapse

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Pelvic floor prolapse

Those who underwent prolift and those who underwent IVS

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

110

Estimated Completion Date

June 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Menahem Neuman, MD

0546444033

mneuman@netvision.net.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01383291

Other Study ID Numbers ^ICMJE

920090041

Has Data Monitoring Committee

Responsible Party

Dr. Menahem Neuman, Western Galilee Hospital and vaious clinics

Study Sponsor ^ICMJE

Western Galilee Hospital-Nahariya

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Western Galilee Hospital-Nahariya

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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