Extended Pessary Interval for Care (EPIC Study) (EPIC)

December 3, 2019 updated by: Unity Health Toronto

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Women's College Hospital/Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 6 months from study enrollment
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.
At 12 months from study enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Mount Sinai Hospital, Canada
Women's College Hospital

Investigators

  • Principal Investigator: Colleen D McDermott, MD, FRCSC, St. Michael's Hospital, Women's College Hospital, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

November 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

June 27, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 19, 2012

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PessaryProtocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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