An interventional study of 6 month follow up for pessary check in the clinic setting in Pelvic Organ Prolapse and Pessary, sponsored by Unity Health Toronto. Status unknown at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment
Objectives: Pelvic organ prolapse (POP) is a common condition for which pessaries are commonly used in conservative treatment. Despite their prevalence, there is no literature to guide the management of pessaries. Our objective is to determine whether patients managed with a pessary for POP are more satisfied with follow-up at 3 or 6 month intervals and if there is any difference in complications rates between the two groups.
Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in the group randomized to 6 month follow-up intervals and that there will be no difference in complication rates between the two follow-up groups.
Method: The investigators will conduct a prospective randomized control trial comparing patient satisfaction and complication rates between patients with pessaries randomized to either 3 or 6 month follow-up intervals over 1 year.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 13 is below the median of 74 across 435 interventional studies indexed under Prolapse.
Browse Prolapse studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Patients seen at 3 month intervals for pessary check-ups is the most common interval check in our clinic so this arm is considered the control group.
Those that will be seen at 6 month follow-up visits for pessary maintenance will be considered the experimental group of the study.
Other: 6 month follow up for pessary check in the clinic setting
The standard of care is considered to be pessary checks every 3 months, therefore those that are checked every 6 months will be considered to be in the intervention group.
Patient satisfaction
To determine if patients managed with a pessary for POP are more satisfied with follow-up at 6 or 12 weeks over a one year period.
Time frame: At 6 months from study enrollment
Patient satisfaction
To determine if patients managed with a pessary for POP are more satisfied with follow-up at 6 or 12 weeks over a one year period.
Time frame: At 12 months from study enrollment
Pessary associated complications
To determine if there is a difference in complication rates associated with indwelling pessaries between those that are seen at 6 week intervals and those that are seen at 12 week intervals, over a one year time period.
Time frame: Checked at all follow-up visits (3 and 6 months, depending on study group)
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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