Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01042470
Recruitment Status : Active, not recruiting
First Posted : January 5, 2010
Last Update Posted : May 14, 2018
University of Zurich
Information provided by (Responsible Party):
David Scheiner, University of Zurich

Brief 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.

Condition or disease
Pelvic Organ Prolapse

Study Type : Observational
Estimated Enrollment : 40 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : June 2015
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

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)

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: David Scheiner, Oberarzt, University of Zurich Identifier: NCT01042470     History of Changes
Other Study ID Numbers: FHKUSZ11-2009
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

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