Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Vaginal infections
Study Overview
Brief Summary
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.
Detailed Description
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:
- Treatment group - will be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly
- Control group - will utilize pessary with an inactive placebo cream
Both the patient and the investigators will be blinded to patient treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study.
Exclusion Criteria
- •have a contraindication to the use of estrogen cream or products
- •have any allergy to the use of estrogen cream or products
- •have a past medical or family history of breast cancer
- •have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant
- •have previously used Premarin vaginal cream
- •are currently using oral estrogen
- •are not competent to consent
Arms & Interventions
Treatment group
These patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly.
Intervention: Premarin vaginal cream (Drug)
Control group
These patients will utilize a pessary with an inactive placebo cream.
Intervention: Placebo cream (Drug)
Outcomes
Primary Outcomes
Vaginal infections
Time Frame: 60 weeks
Vaginal swabs at each follow up visit will be used to detect presence or absence of vaginal infection. A total count of vaginal infections per patient will be compared between groups.
Secondary Outcomes
- Frequency of urinary tract infection(60 weeks)
- Quality of life(60 weeks)