Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • University Hospital of Zurich, Clinic for Gynaecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

female patients who are referred to our university hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
control group; female patients without pelvic organ prolapse, stage 0 or I (POP-Q)
pelvic organ prolapse; female patients with pelvic organ prolapse stage II or higher (POP-Q)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
normative values for the aspiration technique	one year
correlation of elasticity parameters with histology	one year

Collaborators and Investigators

• Sponsor: David Scheiner
• Collaborators: University of Zurich; ETH Zurich (Switzerland)
• Investigators: Principal Investigator: David A Scheiner, MD, University Hospital of Zurich, Clinic for Gynaecology

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 4, 2010
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (Estimate): January 5, 2010

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: biomechanics; pelvic organ prolapse; connective tissue; pelvic floor dysfunction; aspiration device
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: FHKUSZ11-2009