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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(No Intervention)
Patients seen at 6 week intervals for pessary check-ups is the most common interval check in our clinic so this arm is considered the control group.
Those that will be seen at 12 week follow-up visits for pessary maintenance will be considered the experimental group of the study.
12 week follow up for pessary check in the clinic setting
The standard of care is considered to be pessary checks every 6 weeks, therefore those that are checked every 12 weeks will be considered to be in the intervention group.

Primary Outcomes

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

Secondary Outcomes

Pessary associated complications
time frame: Checked at all follow-up visits (6 and 12 weeks, depending on study group)

Eligibility Criteria

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.

Additional Information

Official title Timing of Pessary Follow-up for Pelvic Organ Prolapse: Patient Preference and Complication Rates
Principal investigator Colleen D McDermott, MD, FRCSC
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by St. Michael's Hospital, Toronto.