Quality of Life Clinical Trial
Official title:
Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence
Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.
This will be a double-blinded, placebo-controlled, randomized controlled trial. Eligible
patients presenting to the urogynaecology clinic with pelvic organ prolapse will be offered
management with a pessary and participation in the study
Patients who agree to participate in the study will be given a consent form
Patients in the study and thus those who have opted for pessary use will be randomized
between two groups:
1. Treatment group - will be given instructions for use and prescription for Premarin
vaginal cream 2g at bedtime twice weekly
2. Control group - will utilize pessary with an inactive placebo cream
Both the patient and the investigators will be blinded to patient treatment.
If a patient has expressed willingness to participate in the study over the phone, the
research assistant will issue a study number to the patient and pick up the corresponding
cream from the LHSC pharmacy to give to the patient at their next clinic visit. The cream
will be provided to the patient once they have read the letter of information and signed the
consent form.
For follow-up visits, the research assistant will monitor appointment bookings to ensure that
the cream is ready in the clinic when the patient has their next follow-up visit.
Patients of both groups will be fitted with a pessary. Pessary fitting will be individualized
due to differences in pelvic size and shape and degree of prolapse. Patients may return to
the clinic for subsequent fittings until a successful fit has been achieved. An unsuccessful
fitting is defined as discontinued pessary use due to discomfort or expulsion.
Patients will be assessed for satisfaction and complications 6 wks, 18 wks, 36 wks and 60 wks
after the successful fitting.
To determine patient satisfaction and complications, patients will complete a compilation of
validated questionnaires assessing urinary symptoms, sexual function and quality of life at
each follow-up.
At each follow-up, a vaginal exam will be done and a vaginal swab and urine sample (for
urinalysis and culture and sensitivities) will be taken to assess vaginal bleeding and
infections.
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