NCT01383291

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

February 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

3.9 years

First QC Date

June 26, 2011

Last Update Submit

June 19, 2014

Conditions

Pelvic Floor Prolapse

Keywords

pelvic floor prolapseproliftIVSSurgery

Study Arms (1)

Pelvic floor prolapse

Those who underwent prolift and those who underwent IVS

Eligibility Criteria

Age18 Years - 95 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with pelvic floor prolapse

You may qualify if:

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

You may not qualify if:

  • Women who did not have surgery for pelvic floor prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Obstetrics and Gynecology, Western Galilee Hospital

Nahariya, Israel

Location

Clinics of Dr Neuman

Rishon LeZiyyon, Israel

Location
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 26, 2011

First Posted

June 28, 2011

Study Start

February 1, 2009

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

IL(2)