Pelvic Organ Prolapse, Pessary
Conditions
Keywords
Pelvic organ prolapse, Pessary
Brief 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.
Interventions
OTHER6 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
Women's College Hospital
Mount Sinai Hospital, Canada
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | At 6 months from study enrollment | 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
| Measure | Time frame | Description |
|---|---|---|
| Pessary associated complications | Checked at all follow-up visits (3 and 6 months, depending on study group) | 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. |
Countries
Canada
Outcome results
None listed