Extended Pessary Interval for Care (EPIC Study)

Not Applicable

• Conditions: Pessary; Pelvic Organ Prolapse
• Interventions: Other: 6 month follow up for pessary check in the clinic setting

• Registration Number: NCT01644214
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-19
• Study Start: 2016-11
• Primary Completion: 2019-11
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-04
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 13

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 month Pessary Check	6 month follow up for pessary check in the clinic setting	Those that will be seen at 6 month follow-up visits for pessary maintenance will be considered the experimental group of the study.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	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.

Secondary Outcome Measures

Name	Time	Method
Pessary associated complications	Checked at all follow-up visits (3 and 6 months, depending on study group)	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.

Trial Locations

Locations (1)

Women's College Hospital/Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada