We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01749696
First Posted: December 17, 2012
Last Update Posted: May 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Turku University Hospital
  Purpose
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).

Condition
Pelvic Organ Prolapse

Study Type: Observational
Official Title: Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse.

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • The elastin content in tissue samples in patients with or without pelvic organ prolapse. [ Time Frame: september 2012 ]

Secondary Outcome Measures:
  • The collagen content in tissue samples in women with or without pelvic organ prolapse. [ Time Frame: September 2012 ]

Enrollment: 78
Study Start Date: November 2009
Study Completion Date: April 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

The tissue samples were taken from the anterior wall of vagina in the midline close to cervix or apex. The tissue samples were collected from the vaginal wall of the patients with pelvic organ prolapse (n=39) during vaginal prolapse surgery. Control samples (n=39) were taken from patients after vaginal or laparoscopic removal of the uterus.

The formalin-fixed and paraffin embedded tissue samples were stained with Verhoeff van Gieson and Movat's pentachrome. Samples were examined by pathologist and gynecologist blinded as to the other investigator and to the pelvic organ prolapse status. In case of discrepancy investigators evaluated the samples together to gain consensus.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
39 patients with pelvic organ prolapse and as controls 39 patients without prolapse.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • surgery due to malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749696


Locations
Finland
Department of Obstetrics and Gynecology, Turku University Central Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
  More Information

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01749696     History of Changes
Other Study ID Numbers: 33/180/2009
First Submitted: December 12, 2012
First Posted: December 17, 2012
Last Update Posted: May 9, 2014
Last Verified: May 2014

Keywords provided by Turku University Hospital:
Pelvic organ prolapse
Connective tissue
Elastin
Collagen

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical