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

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749696
• Other study ID #: 33/180/2009
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: May 8, 2014
• Start date: November 2009
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics committee, Turku, Finland':'
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• surgery for pelvic organ prolapse

• hysterectomy due to other benign reasons than pelvic organ prolapse

Exclusion Criteria:

• surgery due to malignancy

Study Design

N/A

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
Finland	Department of Obstetrics and Gynecology, Turku University Central Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The elastin content in tissue samples in patients with or without pelvic organ prolapse.		september 2012	No
Secondary	The collagen content in tissue samples in women with or without pelvic organ prolapse.		September 2012	No