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3D Ultrasound Imaging for Prolapse
N/A
Waitlist Available
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Can perform self-care, i.e. removing and inserting the pessary themselves
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months following data collection
Awards & highlights
Study Summary
This trial is looking at whether 3D ultrasound imaging can help predict the size of a pessary (a passive medical device that is inserted in the vagina to support the pelvic organs) that will fit a patient well, through examining the patient's vagina at different distension volumes.
Who is the study for?
This trial is for women who have been using a pessary to manage pelvic organ prolapse for over 6 months without complications. Participants must be able to give informed consent, handle their own pessary care, and agree to remove it two days before the ultrasound test. Women with certain medical histories or conditions that affect communication or mobility are not eligible.Check my eligibility
What is being tested?
The study tests if 3D translabial ultrasound imaging can accurately predict the correct pessary size needed for each patient, potentially improving upon the current trial-and-error fitting process. The technique involves filling a sterile bag in the vagina with water while taking ultrasound images but does not require direct contact with internal tissues.See study design
What are the potential side effects?
There may be minimal side effects from this non-invasive procedure as it only involves external scanning and vaginal distension without discomfort. However, typical risks of any vaginal examination could include minor discomfort or spotting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can manage my pessary by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months following data collection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months following data collection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
FEASIBILITY: The predicted pessary shape
FEASIBILITY: The predicted pessary size
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with Pelvic Organ ProlapseExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound Imaging
2018
Completed Phase 4
~730
Find a Location
Who is running the clinical trial?
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
57,459 Total Patients Enrolled
1 Trials studying Prolapse
35 Patients Enrolled for Prolapse
Cosm Medical Corp.UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to remove my pessary 2 days before my ultrasound.You are using certain types of pessaries for a medical condition, such as a ring or incontinence dish, but not other types like donut, Shaatz, Marland, or Gellhorn.I have been using a pessary for over 6 months without any issues like discomfort, bleeding, or it falling out.I can manage my pessary by myself.I cannot perform specific breathing or pelvic floor exercises.I have had pelvic radiation or surgery in the past.I cannot walk to test a medical device for comfort during my first visit.I am unable to understand or sign the consent form.You cannot feel anything in your pelvic floor area.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with Pelvic Organ Prolapse
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being enlisted for this experiment?
"Clinicaltrials.gov lists this medical trial as actively recruiting patients; it was initially posted on February 1st 2020 and updated most recently on August 9th 2022."
Answered by AI
What is the current enrollment figure for this clinical trial?
"Correct. The information on clinicaltrials.gov confirms that the investigation, which was initially posted in February 2020, is presently recruiting volunteers for participation. Approximately 35 individuals need to be enrolled from a single medical centre."
Answered by AI
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