Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse
ConditionPelvic Organ Prolapse (POP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alberta
About this trial
Pelvic organ prolapse (POP) is a common health issue. It will impact about half of Canadian women over their lifetime. With POP, organs like the bladder, uterus, and bowel may push into the vagina. Women may experience urine leakage, physical discomfort, and embarrassment. Aside from surgery, a common treatment for POP is the use of pessaries. Pessaries are removable devices placed inside the vagina that can relieve POP symptoms. Unfortunately, pessaries have fixed sizes and three in ten patients cannot find the right fit. Pessaries can cause bleeding and discomfort if they do not fit well or are not removed and cleaned regularly. Almost half of patients who wear pessaries stop using them because of these issues. There is a need for a better pessary treatment for patients.
The investigators have developed a new pessary that has the natural shape of the vagina. This pessary is easier to remove and re-insert. The pessary is also custom fit for each patient. In this study, the investigators will compare our new pessary to traditional pessaries. Study participants who have been fit with a traditional pessary will be asked to use our new pessary design for 3 months. Study participants will fill out questionnaires about their POP symptoms. The investigators will also ask patients to provide their feedback on comfort and how easy it is to use the new pessary. This study could open up new possibilities for treating POP across Canada and around the world.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients assigned female at birth
At least 18 years old at time of screening
Patients with symptomatic POP using a pessary for ≥ 3 months
Capable of giving informed consent
Disqualifiers
Pregnancy
Short vaginal length (total vaginal length <5 cm) or subjective vaginal narrowing
Vaginal erosion due to current pessary
Presence of vesicovaginal fistula
Trial design
Design model
Sequential
Treatments tested in this trial
Novel Personalizable Pessary
DeviceNovel personalizable pessary.
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: Novel Personalizable Pessary ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pelvic Floor Distress Inventory-20 (PFDI-20) score
Comparison of PFDI-20 scores between standard pessary and the study device. Score range 0-300, with higher scores indicating greater burden of pelvic floor symptoms.
Time frame
Approximately 4 months (1 month of standard pessary use and 3 months of study device use).Secondary outcomes
1
Change in Pelvic Floor Impact Questionnaire (PFIQ-7)
Comparison of PFIQ-7 scores between standard pessary to the study device. Scoring ranges from 0-300, with higher scores indicating increasing burden of symptoms.
Time frame
Approximately 4 months (1 month of standard pessary use and 3 months of study device use).2
Change in Patient Global Impression of Improvement (PGI-I)
Change in PGI-I between standard pessary and study device. Utilized to assess symptoms of stress urinary incontinence. Scored from 1 (symptoms very much better) to 7 (symptoms very much worse).
Time frame
Approximately 4 months (1 month of standard pessary use and 3 months of study device use).3
Change in the subscale Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6).
Change in the POPDI-6 subscale within the PFDI-20 between standard pessary and study device. Scoring ranges from 0-100, with higher scores indicating increasing burden of symptoms.
Time frame
Approximately 4 months (1 month of standard pessary use and 3 months of study device use).4
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecologic Association-Revised (PISQ-IR)
Change in PISQ-IR score between standard pessary and the study device. Scoring ranges from 0-300, with higher scores indicating increasing burden of symptoms.
Time frame
Approximately 4 months (1 month of standard pessary use and 3 months of study device use).Other outcomes
1
Study Pessary Fit
Proportion of subjects successfully fit with the study pessary
Time frame
Approximately 4 months (1 month of standard pessary use and 3 months of study device use).2
Patient Self-Management
Percentage of patients able to self-manage the study pessary (self-reported).
Time frame
Approximately 4 months (1 month of standard pessary use and 3 months of study device use).3
Change in frequency of pessary removal for self-managers
Assessment by self-report of frequency of pessary insertion/removal if independent with pessary care.
Time frame
Approximately 4 months (1 month of standard pessary use and 3 months of study device use).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Alberta Innovates Health Solutions
Collaborator
Cosm Medical
Collaborator
Source ClinicalTrials.gov