NCT01749696

Brief Summary

The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

2.8 years

First QC Date

December 12, 2012

Last Update Submit

May 8, 2014

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic organ prolapseConnective tissueElastinCollagen

Outcome Measures

Primary Outcomes (1)

  • The elastin content in tissue samples in patients with or without pelvic organ prolapse.

    september 2012

Secondary Outcomes (1)

  • The collagen content in tissue samples in women with or without pelvic organ prolapse.

    September 2012

Study Arms (2)

Patients with pelvic organ prolapse

Patients, who were operated on because of pelvic organ prolapse.

Patients without pelvic organ prolapse

Patients, who had hysterectomy due to other reasons than pelvic organ prolapse.

Eligibility Criteria

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

39 patients with pelvic organ prolapse and as controls 39 patients without prolapse.

You may qualify if:

  • surgery for pelvic organ prolapse
  • hysterectomy due to other benign reasons than pelvic organ prolapse

You may not qualify if:

  • surgery due to malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Turku University Central Hospital

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseAortic Stenosis, Supravalvular

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

November 1, 2009

Primary Completion

September 1, 2012

Study Completion

April 1, 2014

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

FI(1)