Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
ETH Zurich, Center of Mechanics
University of Zurich
Information provided by (Responsible Party):
David Scheiner, University of Zurich
ClinicalTrials.gov Identifier:
NCT01042470
First received: January 4, 2010
Last updated: March 9, 2012
Last verified: March 2012

January 4, 2010
March 9, 2012
January 2010
January 2013   (final data collection date for primary outcome measure)
  • normative values for the aspiration technique [ Time Frame: one year ] [ Designated as safety issue: No ]
  • correlation of elasticity parameters with histology [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01042470 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

tissue (vaginal wall, urogenital diaphragm), whole blood

Non-Probability Sample

female patients who are referred to our university hospital

Pelvic Organ Prolapse
Not Provided
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: David A Scheiner, MD +41442559308 david.scheiner@usz.ch
Switzerland
 
NCT01042470
FHKUSZ11-2009
No
David Scheiner, University of Zurich
David Scheiner
  • ETH Zurich, Center of Mechanics
  • University of Zurich
Principal Investigator: David A Scheiner, MD University Hospital of Zurich, Clinic for Gynaecology
University of Zurich
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP