Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor

Pelvic Organ Prolapse Clinical Trial

Official title:

Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor - Evaluation of Clinical, Mechanical, Sonographic and Histological Parameters

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01042470
• Other study ID #: FHKUSZ11-2009
• Status: Active, not recruiting
• Start date: January 2010
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pelvic floor dysfunction in the form of pelvic organ prolapse or urinary and fecal incontinence is a sequela for some women who experience injuries during birth. It affects adult women of all ages. The life time risk for women by age of 80 years for undergoing surgical correction is shown to be 11.1 % , and 29 % of them will undergo re-operation for recurrences later on. Still, even today the biomechanics of the pelvic floor is not understood enough. The aim of our study is to investigate the biomechanical properties of the female pelvic floor, i.e. the vaginal wall, by means of clinical, sonomorphometric (ultrasound), histological and elastomechanical examinations. In principle, the elasto-mechanical properties of the vaginal wall will be examined by the new and innovative so called aspiration device, developed at the Eidgenoessische Technische Hochschule (ETH) Zurich, Switzerland. This tool generates a low-pressure of -25 mbar at the vaginal wall, aspirating it under visual control by aid of an integrated video camera and therefore allowing to measure the difference of its convexity under aspiration and at rest. In case of prolapse surgery, this allows us to take a biopsy of the measured vaginal wall and analyze it at the Institute of Anatomy at the University of Zurich-Irchel by means of histological (e.g. connective tissue, extracellular matrix) and molecular biological examination. With an increasing elderly population, more and more women will need surgery for pelvic organ prolapse. While effective in restoring anatomy, sometimes by aid of meshes made out of polypropylene, the functional outcomes and quality of life are not always restored satisfactorily. This interdisciplinary project intends to add a contribution to this for our patient still bothersome situation and to help to detect risk factors for developing pelvic floor dysfunction.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2021
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pre- and postmenopausal women
• with pelvic organ prolapse, i.e. cysto- or rectocele, uterine descensus
• postmenopausal women

Exclusion Criteria:

• age under 18 years
• pregnancy / lactation
• current gynaecologic malignancies
• current malignancies of the pelvic floor
• infections such as HPV
• treatment with steroids or methotrexate
• no informed consent

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich, Clinic for Gynaecology	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
David Scheiner	ETH Zurich (Switzerland), University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normative values for the aspiration technique		one year
Primary	correlation of elasticity parameters with histology		one year