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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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.
Women's College Hospital/Mount Sinai Hospital
Toronto, Ontario, Canada
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.