MedTrace Logo

Extended Pessary Interval for Care (EPIC Study)

NCT01644214 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-12-04

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse
  • Pessary

Interventions

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.

Sponsors & Collaborators

  • Women's College Hospital

    collaborator OTHER

  • Mount Sinai Hospital, Canada

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-11-30
Completion
2020-03-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644214 on ClinicalTrials.gov