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Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor

NCT01042470 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2020-11-06

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

Sponsors & Collaborators

  • ETH Zurich (Switzerland)

    collaborator OTHER

  • University of Zurich

    collaborator OTHER

  • David Scheiner

    lead OTHER

Principal Investigators

  • David A Scheiner, MD · University Hospital of Zurich, Clinic for Gynaecology

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-06-30
Completion
2021-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01042470 on ClinicalTrials.gov