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
  Purpose

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
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 University of Zurich:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

tissue (vaginal wall, urogenital diaphragm), whole blood


Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

female patients who are referred to our university hospital

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042470

Contacts
Contact: David A Scheiner, MD +41442559308 david.scheiner@usz.ch

Locations
Switzerland
University Hospital of Zurich, Clinic for Gynaecology Recruiting
Zürich, Switzerland, 8091
Contact: David A Scheiner, MD    +41442559308    david.scheiner@usz.ch   
Sponsors and Collaborators
David Scheiner
ETH Zurich, Center of Mechanics
University of Zurich
Investigators
Principal Investigator: David A Scheiner, MD University Hospital of Zurich, Clinic for Gynaecology
  More Information

No publications provided

Responsible Party: David Scheiner, Oberarzt, University of Zurich
ClinicalTrials.gov Identifier: NCT01042470     History of Changes
Other Study ID Numbers: FHKUSZ11-2009
Study First Received: January 4, 2010
Last Updated: March 9, 2012
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014