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Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor

This study is ongoing, but not recruiting participants.
University of Zurich
Information provided by (Responsible Party):
David Scheiner, University of Zurich Identifier:
First received: January 4, 2010
Last updated: June 8, 2017
Last verified: June 2017
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.

Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor - Evaluation of Clinical, Mechanical, Sonographic and Histological Parameters

Resource links provided by NLM:

Further study details as provided by David Scheiner, University of Zurich:

Primary Outcome Measures:
  • normative values for the aspiration technique [ Time Frame: one year ]
  • correlation of elasticity parameters with histology [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
tissue (vaginal wall, urogenital diaphragm), whole blood

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
female patients who are referred to our university hospital

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01042470

University Hospital of Zurich, Clinic for Gynaecology
Zürich, Switzerland, 8091
Sponsors and Collaborators
David Scheiner
University of Zurich
Principal Investigator: David A Scheiner, MD University Hospital of Zurich, Clinic for Gynaecology
  More Information

Responsible Party: David Scheiner, Oberarzt, University of Zurich Identifier: NCT01042470     History of Changes
Other Study ID Numbers: FHKUSZ11-2009
Study First Received: January 4, 2010
Last Updated: June 8, 2017

Keywords provided by David Scheiner, University of Zurich:
pelvic organ prolapse
pelvic floor dysfunction
aspiration device
connective tissue

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pathological Conditions, Anatomical processed this record on September 19, 2017