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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
Women's College Hospital, Toronto
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01644214
First received: June 27, 2012
Last updated: November 7, 2016
Last verified: November 2016
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Pessary
Other: 6 month follow up for pessary check in the clinic setting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: At 6 months from study enrollment ] [ Designated as safety issue: No ]
    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 12 months from study enrollment ] [ Designated as safety issue: No ]
    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:
  • Pessary associated complications [ Time Frame: Checked at all follow-up visits (3 and 6 months, depending on study group) ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 70
Study Start Date: November 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644214

Contacts
Contact: Colleen D McDermott, MD, FRCSC 416 585 4642 colleen.mcdermott@utoronto.ca
Contact: Danny Lovatsis, MD, FRCSC Danny.Lovatsis@sinaihealthsystem.ca

Locations
Canada, Ontario
Women's College Hospital/Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Colleen D McDermott, MD, FRCSC    416 585 4642    colleen.mcdermott@utoronto.ca   
Sub-Investigator: Danny Lovatsis, MD, FRCSC         
Women's College Hospital/Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Colleen D McDermott, MD, FRCSC    416 585 4642    colleen.mcdermott@utoronto.ca   
Contact: Danny Lovatsis, MD, FRCSC       danny.lovatsis@sinaihealthsystems.ca   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Women's College Hospital, Toronto
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Colleen D McDermott, MD, FRCSC St. Michael's Hospital, Women's College Hospital, University of Toronto
  More Information

Publications:

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01644214     History of Changes
Other Study ID Numbers: PessaryProtocol 
Study First Received: June 27, 2012
Last Updated: November 7, 2016
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Pelvic organ prolapse
Pessary

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on December 08, 2016