NCT02383199

Brief Summary

The purpose of this study was to report the long-term objective and subjective outcome after prolapse surgery with polypropylene mesh. The complications and the effect of the learning curve of the surgeons to the outcome is also reported.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

February 2, 2015

Last Update Submit

March 26, 2015

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Subjective outcome with validated questionnaires

    Validated questionnaires

    7 years

Secondary Outcomes (2)

  • Objective outcome: anatomic outcome with Pelvic Organ Prolapse Quantification (POP-Q) system

    7 years

  • Number of patients with adverse events and reoperations.

    7 years

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

195 first patients with pelvic organ prolapse operated on a in Turku University Hospital using polypropylene mesh

195 first patients with pelvic organ prolapse operated on using polypropylene mesh

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Pia Heinonen, MD

    Turku university hospital, Department of gynecology and obsteterics, Turku, Finland':'

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

March 9, 2015

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03