Pelvic Organ ProlapseNCT01042470
Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor
An observational study of Pelvic Organ Prolapse, run by David Scheiner at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: female patients who are referred to our university hospital
Who may be able to join
- pre- and postmenopausal women
- with pelvic organ prolapse, i.e. cysto- or rectocele, uterine descensus
- postmenopausal women
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich, Clinic for Gynaecology
Zurich, 8091
About this study
Official title: Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor - Evaluation of Clinical, Mechanical, Sonographic and Histological Parameters
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
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
normative values for the aspiration technique
Measured: one year
correlation of elasticity parameters with histology
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2015
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Scheiner
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich (Switzerland), University of Zurich
- Responsible party
- Sponsor-investigator, David Scheiner, University of Zurich
- Investigators
- David A Scheiner, MD, Principal investigator, University Hospital of Zurich, Clinic for Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042470
- Sponsor's protocol ID
- FHKUSZ11-2009
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2010
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor - Evaluation of Clinical, Mechanical, Sonographic and Histological Parameters
- ClinicalTrials.gov ID
- NCT01042470
- Acronym / sponsor ID
- FHKUSZ11-2009
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, pelvic floor dysfunction, biomechanics, aspiration device, connective tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- David ScheinerUniversity, hospital or other
- Collaborators
- ETH Zurich (Switzerland), University of Zurich
- Study start
- Jan 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- female patients who are referred to our university hospital
Key inclusion criteria (3 listed)
- pre- and postmenopausal women
- with pelvic organ prolapse, i.e. cysto- or rectocele, uterine descensus
- postmenopausal women
Key exclusion criteria (7 listed)
- age under 18 years
- pregnancy / lactation
- current gynaecologic malignancies
- current malignancies of the pelvic floor
- infections such as HPV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
normative values for the aspiration technique
Time frame: one year
correlation of elasticity parameters with histology
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
Related trials for Pelvic Organ Prolapse
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Scheiner, MD principal investigator
University Hospital of Zurich, Clinic for Gynaecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by David Scheiner at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normative values for the aspiration technique (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.