Timing of Pessary Follow-up for Pelvic Organ Prolapse
This trial is active, not recruiting.
|Conditions||pelvic organ prolapse, pessary|
|Treatment||12 week follow up for pessary check in the clinic setting|
|Sponsor||St. Michael's Hospital, Toronto|
|Start date||October 2012|
|End date||May 2017|
|Trial size||70 participants|
|Trial identifier||NCT01644214, PessaryProtocol|
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 6 or 12 week 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 12 week 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 6 or 12 week follow-up intervals over 1 year.
|Intervention model||parallel assignment|
time frame: At 6 months from study enrollment
time frame: At 12 monhs from study enrollment
Pessary associated complications
time frame: Checked at all follow-up visits (6 and 12 weeks, depending on study group)
Female participants at least 18 years old.
Inclusion Criteria: - All patients seen at SMH successfully fitted with a pessary for management of symptomatic POP will be eligible, females over the age of 18, able to read and write English. Exclusion Criteria: - Current presence of vaginal bleeding, vaginal abrasions or ulcers, or vaginal infection; - significant cognitive impairment; - pessary used for indication other than POP; - use of a cube pessary; 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); - patients that have had a successful pessary fitting but are doing their own pessary maintenance at home and do not require regular follow-up at the clinic for this device.
|Official title||Timing of Pessary Follow-up for Pelvic Organ Prolapse: Patient Preference and Complication Rates|
|Principal investigator||Colleen D McDermott, MD, FRCSC|
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