ProlapseNCT04099121
Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation
A study testing Ultrasound Imaging in people with Prolapse, run by Western University, Canada at 1 site in Canada.
Trial summary
Symptoms of female pelvic floor dysfunction, such as incontinence and pelvic organ prolapse, can be alleviated by using pessaries, which are passive medical devices that are inserted in the vagina to support the pelvic organs. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Prolapse
- What is being tested?
- Ultrasound Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2020to 1 Nov 2023
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current pessary users (> 6 months) who have no pessary related complication, including discomfort, repeated vaginal bleeding, and pessary extrusion
- Are able to provide informed consent
- Can perform self-care, i.e. removing and inserting the pessary themselves
- Are willing to remove their pessary 2 days before the ultrasound examination date.
Who cannot join
- Inability to give informed consent
- Inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning
- History of pelvic radiation or surgery, (including hysterectomy)
- Using pessaries other than ring, incontinence dish, donut, Shaatz, Marland, or Gellhorn.
- Inability to perform the Valsalva maneuver or pelvic floor contraction
- Restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit.
- Lack of sensation at the pelvic floor.
- Being pregnant at the time of the examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of 3D Ultrasound Vaginal Manometry for Estimating the Optimal Pessary Size for Patients With Pelvic Organ Prolapse
Symptoms of female pelvic floor dysfunction, such as incontinence and pelvic organ prolapse, can be alleviated by using pessaries, which are passive medical devices that are inserted in the vagina to support the pelvic organs. Currently, pessaries are fit through trial and error after manual examination, the accuracy of which depends on the physician's expertise level.
The objective of this study is to evaluate the feasibility of using 3D translabial ultrasound imaging of the vagina at various distension volumes to predict the pessary size for successful fit. Ultrasound images will be obtained using commercially available 3D ultrasound probes (Philips, Netherlands), as well as a commercially available 2D ultrasound probe (Philips, Netherlands), which is linearly scanned to capture a 3D volume. The linear scanning will be performed by attaching the 2D probe to a motorized hand-held scanner, which is used to tilt and move the probe to acquire images. Please note that the hand-held scanner does not come in contact with the patient. To distend the vagina, a sterile bag is inserted in the vagina and gradually filled with water using a commercially available urodynamic system (Laborie, Canada) until the vaginal capacity is reached, without causing any discomfort to the patient. This image acquisition technique, previously reported in the literature, is referred to as 3D ultrasound vaginal manometry in this study.
To achieve the objective of this project, 35 pelvic organ prolapse patients, who (i) are current pessary users, (ii) can perform self-care of the pessary, and (iii) can provide informed consent, will be invited to participate in the study. Patients will be asked to remove their pessary prior to ultrasound imaging. Then, 3D ultrasound vaginal manometry will be performed, using the technique described above. Ultrasound images will be analyzed once data acquisition is completed. The size of the pessary estimated from ultrasound images will be compared with the actual pessary size used by the patient.
- Conditions
- Prolapse
- Being tested
- Ultrasound Imaging
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ImagingDevice
3D ultrasound of the pelvic floor and vaginal cavity will be obtained by using a commercial ultrasound system.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Pelvic Organ Prolapse | Other | Patients who meet the inclusion criteria will be recruited. Ultrasound images of the pelvic floor and vaginal cavity will be analyzed to predict pessary size and type. This will be compared against the pessary size and type being used already by the patient. Receives: Device: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEASIBILITY: The predicted pessary size
The predicted pessary size in cubic mm will be compared with the actual size of the pessary used by the patient
Measured: Up to 3 months following data collection
FEASIBILITY: The predicted pessary shape
The predicted pessary shape will be compared with the actual shape of the pessary used by the patient by calculating the DICE coefficient.
Measured: Up to 3 months following data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Feb 2020
- Primary completion5 Sep 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlapseStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Cosm Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099121
- Sponsor's protocol ID
- 6086
- Status last verified
- Apr 2024
- First submitted
- 1 May 2019
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be de-identified, and only the aggregate results will be used for publication. Patient information will not be made public or shared with researchers outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Ultrasound Vaginal Manometry for Estimating the Optimal Pessary Size for Patients With Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT04099121
- Acronym / sponsor ID
- 6086
- Conditions
- Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Cosm Medical
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 23 Sep 2019 (actual)
- 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.
Symptoms of female pelvic floor dysfunction, such as incontinence and pelvic organ prolapse, can be alleviated by using pessaries, which are passive medical devices that are inserted in the vagina to support the pelvic organs. Currently, pessaries are fit through trial and error after manual examination, the accuracy of which depends on the physician's expertise level.
The objective of this study is to evaluate the feasibility of using 3D translabial ultrasound imaging of the vagina at various distension volumes to predict the pessary size for successful fit. Ultrasound images will be obtained using commercially available 3D ultrasound probes (Philips, Netherlands), as well as a commercially available 2D ultrasound probe (Philips, Netherlands), which is linearly scanned to capture a 3D volume. The linear scanning will be performed by attaching the 2D probe to a motorized hand-held scanner, which is used to tilt and move the probe to acquire images. Please note that the hand-held scanner does not come in contact with the patient. To distend the vagina, a sterile bag is inserted in the vagina and gradually filled with water using a commercially available urodynamic system (Laborie, Canada) until the vaginal capacity is reached, without causing any discomfort to the patient. This image acquisition technique, previously reported in the literature, is referred to as 3D ultrasound vaginal manometry in this study.
To achieve the objective of this project, 35 pelvic organ prolapse patients, who (i) are current pessary users, (ii) can perform self-care of the pessary, and (iii) can provide informed consent, will be invited to participate in the study. Patients will be asked to remove their pessary prior to ultrasound imaging. Then, 3D ultrasound vaginal manometry will be performed, using the technique described above. Ultrasound images will be analyzed once data acquisition is completed. The size of the pessary estimated from ultrasound images will be compared with the actual pessary size used by the patient.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Pelvic Organ Prolapse | Other | Device: Ultrasound ImagingPatients who meet the inclusion criteria will be recruited. Ultrasound images of the pelvic floor and vaginal cavity will be analyzed to predict pessary size and type. This will be compared against the pessary size and type being used already by the patient. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Current pessary users (> 6 months) who have no pessary related complication, including discomfort, repeated vaginal bleeding, and pessary extrusion
- Are able to provide informed consent
- Can perform self-care, i.e. removing and inserting the pessary themselves
- Are willing to remove their pessary 2 days before the ultrasound examination date.
Key exclusion criteria (8 listed)
- Inability to give informed consent
- Inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning
- History of pelvic radiation or surgery, (including hysterectomy)
- Using pessaries other than ring, incontinence dish, donut, Shaatz, Marland, or Gellhorn.
- Inability to perform the Valsalva maneuver or pelvic floor contraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Imaging3D ultrasound of the pelvic floor and vaginal cavity will be obtained by using a commercial ultrasound system. | Device | Patients with Pelvic Organ Prolapse |
Primary outcome
FEASIBILITY: The predicted pessary size
Time frame: Up to 3 months following data collection
The predicted pessary size in cubic mm will be compared with the actual size of the pessary used by the patient
FEASIBILITY: The predicted pessary shape
Time frame: Up to 3 months following data collection
The predicted pessary shape will be compared with the actual shape of the pessary used by the patient by calculating the DICE coefficient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No. Data will be de-identified, and only the aggregate results will be used for publication. Patient information will not be made public or shared with researchers outside of the study team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Imaging in people with Prolapse, run by Western University, Canada at 1 site in Canada.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 30 Apr 2024. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FEASIBILITY: The predicted pessary size (time frame: Up to 3 months following data collection). 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 30 Apr 2024.