Extended Pessary Interval for Care (EPIC Study)

Study Overview
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Brief Summary
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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.

Official Title
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Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up

Conditions
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Pelvic Organ Prolapse, Pessary

Intervention / Treatment
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* Other: 6 month follow up for pessary check in the clinic setting


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pessary Check at 3 months<br>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. | |
| Experimental: 6 month Pessary Check<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At 12 months from study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Checked at all follow-up visits (3 and 6 months, depending on study group) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic organ prolapse, Pessary