NCT01387685

Brief Summary

Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.

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withdrawn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 29, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

3.9 years

First QC Date

June 29, 2011

Last Update Submit

June 19, 2014

Conditions

Pelvic Floor Prolapse

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with study outcome

    six to twelve months after surgery

Secondary Outcomes (1)

  • Side effects of the surgery: pain, vaginal erosion by tape, bleeding

    Within six to twelve months after study

Eligibility Criteria

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

Women who underwent surgery for pelvic floor prolapse who underwent surgery by eithe surgeon-cut-mesh or by PIVS

You may qualify if:

  • Women who underwent surgery for pelvic floor prolapse

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

Dr Neuman clinic

Tel Aviv, 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 29, 2011

First Posted

July 4, 2011

Study Start

February 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

IL(2)