Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor

NCT ID: NCT01042470

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2021-12-31

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.

Conditions

Pelvic Organ Prolapse

Keywords

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

control group

female patients without pelvic organ prolapse, stage 0 or I (POP-Q)

No interventions assigned to this group

pelvic organ prolapse

female patients with pelvic organ prolapse stage II or higher (POP-Q)

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ETH Zurich (Switzerland)

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

David Scheiner

OTHER

Sponsor Role: lead

Responsible Party

David Scheiner

Oberarzt

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David A Scheiner, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Zurich, Clinic for Gynaecology

Locations

University Hospital of Zurich, Clinic for Gynaecology

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

FHKUSZ11-2009

Identifier Type: -

Identifier Source: org_study_id