Clinical trial NCT01042470: Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor
Official title: Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor - Evaluation of Clinical, Mechanical, Sonographic and Histological Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
pelvic floor dysfunction
biomechanics
aspiration device
connective tissue
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich (Switzerland)
name: University of Zurich
First posted: 2010-01-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients who are referred to our university hospital

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.


Eligibility 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

Primary outcomes:
measure: normative values for the aspiration technique
timeFrame: one year
measure: correlation of elasticity parameters with histology
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital of Zurich, Clinic for Gynaecology
Study officials:
affiliation: University Hospital of Zurich, Clinic for Gynaecology
name: David A Scheiner, MD
role: PRINCIPAL_INVESTIGATOR
References: