Pelvic Organ ProlapseNCT03955744
3D Translabial Ultrasound for Pessary Size Estimation
A study testing 3D translabial ultrasound in people with Pelvic Organ Prolapse, run by Western University, Canada at 1 site in Canada.
Trial summary
This is a feasibility study looking at the use of 3D ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- 3D translabial ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 18 Dec 2019to 17 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
- are current pessary users (> 6 months) who have no pessary related complication, including discomfort, 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 two 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 (excluding hysterectomy)
- using pessaries other than ring, incontinence dish, donut, Shaatz
- 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 Translabial Ultrasound Imaging for Pessary Size Estimation
This is a feasibility study looking at the use of 3D ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit.
Read the detailed description
Patients who are currently using a pessary for management of pelvic organ prolapse and who are able to remove/replace the pessary themselves will be approached for recruitment. The pessary will be removed two days prior to 3D translabial ultrasound. The vagina will be distended with a pressurized compliant bag with concurrent pressure and volume measurements. Translabial ultrasound will be used to measure structural parameters within the vagina at varying pressures/volumes. The volume, pressure and structural parameters measured will be compared to dimensions of the patient's own pessary to develop mathematical models to predict the best available pessary choice for the patient.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- 3D translabial ultrasound
- 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.
3D translabial ultrasoundOther
All patients will undergo 3D translabial ultrasound with vaginal manometry
| Study group | Role | What they receive |
|---|---|---|
| 3D translabial ultrasound | Experimental | 3D translabial ultrasound with concurrent vaginal manometry Receives: Other: 3D translabial ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse
3D ultrasound images of the vaginal canal and the pelvic floor will be obtained using various ultrasound probes. Pressure and volume measurements (i.e. manometry) will be obtained using a urodynamic system.
Measured: 1 hour and 20 minutes (i.e. the estimated time for the ultrasound and manometry examination per participant).
Secondary outcomes (1)
Survey
Participants will be asked to fill out a short survey about their experience with the pessaries they already use and the ultrasound examination process
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start18 Dec 2019
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Why it stopped: Sponsor terminated study as there had been sufficient data collected from the recruited patients to characterize vaginal contraction biomechanics
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.
- 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
- 21 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
- NCT03955744
- Sponsor's protocol ID
- 113264
- Other IDs
- 6086
- Status last verified
- May 2024
- First submitted
- 6 May 2019
- Last updated
- 2 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Translabial Ultrasound Imaging for Pessary Size Estimation
- ClinicalTrials.gov ID
- NCT03955744
- Acronym / sponsor ID
- 113264
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated study as there had been sufficient data collected from the recruited patients to characterize vaginal contraction biomechanics
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Cosm Medical
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 20 May 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.
This is a feasibility study looking at the use of 3D ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit.
Detailed description
Patients who are currently using a pessary for management of pelvic organ prolapse and who are able to remove/replace the pessary themselves will be approached for recruitment. The pessary will be removed two days prior to 3D translabial ultrasound. The vagina will be distended with a pressurized compliant bag with concurrent pressure and volume measurements. Translabial ultrasound will be used to measure structural parameters within the vagina at varying pressures/volumes. The volume, pressure and structural parameters measured will be compared to dimensions of the patient's own pessary to develop mathematical models to predict the best available pessary choice for 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 |
|---|---|---|
| 3D translabial ultrasound | Experimental | Other: 3D translabial ultrasound3D translabial ultrasound with concurrent vaginal manometry |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- are current pessary users (> 6 months) who have no pessary related complication, including discomfort, 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 two 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 (excluding hysterectomy)
- using pessaries other than ring, incontinence dish, donut, Shaatz
- 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 |
|---|---|---|
| 3D translabial ultrasoundAll patients will undergo 3D translabial ultrasound with vaginal manometry | Other | 3D translabial ultrasound |
Primary outcome
3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse
Time frame: 1 hour and 20 minutes (i.e. the estimated time for the ultrasound and manometry examination per participant).
3D ultrasound images of the vaginal canal and the pelvic floor will be obtained using various ultrasound probes. Pressure and volume measurements (i.e. manometry) will be obtained using a urodynamic system.
1 secondary outcome
Survey
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: Sponsor terminated study as there had been sufficient data collected from the recruited patients to characterize vaginal contraction biomechanics). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: No
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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 3D translabial ultrasound in people with Pelvic Organ 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: stopped early, as of the sponsor's last update on 2 May 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 was stopped early (reason given: Sponsor terminated study as there had been sufficient data collected from the recruited patients to characterize vaginal contraction biomechanics). 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?
3D ultrasound images and pressure/volume measurements of vagina in patients with pelvic organ prolapse (time frame: 1 hour and 20 minutes (i.e. the estimated time for the ultrasound and manometry examination per participant).). 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 2 May 2024.