Overview

Conditions pelvic organ prolapse, pessary
Treatment 6 month follow up for pessary check in the clinic setting
Sponsor St. Michael's Hospital, Toronto
Collaborator Women's College Hospital, Toronto
Start date November 2016
End date December 2018
Trial size 70 participants
Trial identifier NCT01644214, PessaryProtocol

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries Canada

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
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)
Those that will be seen at 6 month follow-up visits for pessary maintenance will be considered the experimental group of the study.
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.

Primary Outcomes

Measure
Patient satisfaction
time frame: At 6 months from study enrollment
Patient satisfaction
time frame: At 12 months from study enrollment

Secondary Outcomes

Measure
Pessary associated complications
time frame: Checked at all follow-up visits (3 and 6 months, depending on study group)

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up
Principal investigator Colleen D McDermott, MD, FRCSC
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by St. Michael's Hospital, Toronto.