Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Unity Health Toronto
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Patient satisfaction
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Females with POP who have opted for conservative management with a pessary
- •Able to read and write English
- •First time pessary users
- •Successful fitting with a covered ring or Gellhorn pessary, as determined at the usual early follow-up visit 2-4 weeks after initial fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
- •Patients agree to use vaginal estrogen (either tablet or cream twice weekly) during the study period; patients may not use a vaginal estrogen ring since this requires changing every 3 months, and will interfere with the study follow-up schedule
Exclusion Criteria
- •Current presence of vaginal bleeding, vaginal abrasions or ulcers, or vaginal infection
- •Significant cognitive impairment
- •Pessary used for indication other than POP (ie. urinary incontinence)
- •Use of a pessary that is not a covered ring or Gellhorn (i.e exclude cube, donut, etc.)
- •Contraindications to vaginal estrogen
- •Unsuccessful pessary fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
Arms & Interventions
Pessary Check at 3 months
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.
6 month Pessary Check
Those that will be seen at 6 month follow-up visits for pessary maintenance will be considered the experimental group of the study.
Intervention: 6 month follow up for pessary check in the clinic setting (Other)
Outcomes
Primary Outcomes
Patient satisfaction
Time Frame: At 12 months from study enrollment
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.
Patient satisfaction
Time Frame: At 6 months from study enrollment
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.
Secondary Outcomes
- Pessary associated complications(Checked at all follow-up visits (3 and 6 months, depending on study group))