Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor
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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 |
- 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 |
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| Contact: David A Scheiner, MD | +41442559308 | david.scheiner@usz.ch |
| Switzerland | |
| University Hospital of Zurich, Clinic for Gynaecology | Recruiting |
| Zürich, Switzerland, 8091 | |
| Contact: David A Scheiner, MD +41442559308 david.scheiner@usz.ch | |
| 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 June 18, 2013