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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01042470
Enrollment
40
Registered
2010-01-05
Start date
2010-01-31
Completion date
2021-12-31
Last updated
2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse, pelvic floor dysfunction, biomechanics, aspiration device, connective tissue

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.

Interventions

None listed

Sponsors

ETH Zurich (Switzerland)
CollaboratorOTHER
University of Zurich
CollaboratorOTHER
David Scheiner
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
normative values for the aspiration techniqueone year
correlation of elasticity parameters with histologyone year

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026