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Completed

NCT Number: NCT01749696

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

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).

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Key information

Conditions

Pelvic Organ Prolapse Aortic Stenosis, Supravalvular Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Ventricular Outflow Obstruction

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynecology, Turku University Central Hospital

Turku, 20520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • surgery due to malignancy

Treatment and study plan

Primary outcomes

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

    Time frame: september 2012

Secondary outcomes

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

    Time frame: September 2012

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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