Extended Pessary Interval for Care (EPIC Study)

Unity Health Toronto

Status

Unknown

Conditions

Pessary

Pelvic Organ Prolapse

Treatments

Other: 6 month follow up for pessary check in the clinic setting

Study type

Interventional

Funder types

Other

Identifiers

NCT01644214

PessaryProtocol

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)