NCT01392417

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 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

July 3, 2014

Status Verified

July 1, 2011

Enrollment Period

3.9 years

First QC Date

June 29, 2011

Last Update Submit

July 2, 2014

Conditions

Pelvic Floor Prolapse

Outcome Measures

Primary Outcomes (1)

  • Symptoms of pelvic floor prolapse

    We will question the women if they have a feeling of a mass protruding through the labia. Physical examination data will also be incorporated.

    One year after surgery

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 who underwent surgery with Prolift

You may qualify if:

  • Women who underwent surgery by anterior Prolift or posterior Prolift for pelvic floor prolapse

You may not qualify if:

  • Women who did not have surgery by Prolift 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

Tel Aviv, Israel

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2011

First Posted

July 12, 2011

Study Start

February 1, 2009

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

July 3, 2014

Record last verified: 2011-07

Locations

IL(2)