Vaginal Estradiol Use in Pessary Care

Study Overview
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Brief Summary
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The primary outcome of this study compare the rate of pessary discontinuation at 6 months post-pessary fitting in women using vaginal estradiol versus those not using vaginal estradiol.

Detailed Description
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The purpose of the study is to investigate the effects of vaginal estradiol cream on pessary care. All patients presenting to the University of South Florida Urogynecology clinic for pessary fitting for pelvic organ prolapse and/or urinary incontinence are screened as potential study participants. After being informed of risks and benefits of participations and consent is obtained, patients that have been successfully fitted for a pessary and agree to participate will be separated into two groups: the control group or treatment group. The treatment group will be provided with a prescription for vaginal estradiol cream. Vaginal estradiol cream is FDA approved and is the first line treatment for vaginal atrophy, also known as dryness. The study will be unblinded and randomized, neither the participant nor the study doctor will choose which group the will be participant will be placed in. The participant will have an equal chance of being given either treatment. The treatment group will be asked to apply vaginal estradiol cream nightly for two weeks and then twice weekly thereafter. All participants will have 2 study visits over a 6-month period which is standard for pessary care: a regular follow up pessary check visit two weeks after pessary fitting and second visit 6 months later. At these visits, questions regarding symptoms including vaginal bleeding, vaginal discharge, and discomfort with pessary will be assessed and a physical exam will be performed as is standard for all pessary users.

Official Title
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Vaginal Estradiol Use in Pessary Management: A Randomized Controlled Trial

Conditions
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Pelvic Organ Prolapse, Urinary Incontinence, Pessary Ulcer of Vagina, Vaginal Atrophy

Intervention / Treatment
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* Drug: Estradiol vaginal cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Postmenopausal status Recent pessary fitting Office-based and home-based pessary care Exclusion Criteria: Women < 18 years old Women currently on hormone replacement therapy (pill, patch, pellet) Women currently using vaginal estradiol cream within the last 4 weeks Medical contraindications to vaginal estradiol including unevaluated vaginal bleeding Inability to apply vaginal estradiol cream Inability to provide informed consent Inability to comprehend written and/or spoken English or Spanish Inability to comply with study visit schedule

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The study design will be a randomized controlled trial involving patients seen in the Urogynecology clinic with pelvic organ prolapse or incontinence who were recently fit with a pessary.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Participants will receive standard pessary care. Participation requires follow up visit 6 months from initial baseline visit. At this visit, participants are asked about vaginal bleeding, degree of bother due to vaginal discharge, and degree of pessary discomfort and a physical exam is performed. | |
| Experimental: Estrogen Group<br>Participants will receive standard pessary care, and those participants randomized to the experimental group will then be given a prescription for vaginal estradiol and instructed to apply it in the vagina nightly for two weeks and then twice weekly thereafter. Participation requires follow up visit 6 months from initial baseline visit. At this visit, participants are asked about vaginal bleeding, degree of bother due to vaginal discharge, and degree of pessary discomfort and a physical exam is performed. | Drug: Estradiol vaginal cream<br>* Insert pea-sized amount of vaginal estradiol cream into vagina nightly for first two weeks and then twice weekly thereafter.<br>* Other names: National Drug Code 0430-3754;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pessary Discontinuation Rates | To compare the rate of pessary discontinuation at 6 months post-pessary fitting in estrogen group and no intervention group | 6 Months Post-Pessary Fitting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phone calls/messages | To compare the number of phone calls/messages from patients to the office regarding pessary management symptoms in estrogen group and no intervention group | 6 Months Post-Pessary Fitting | 
| Unscheduled office visits | To compare the number of unscheduled office visits from patients in estrogen group and no intervention group | 6 Months Post-Pessary Fitting | 
| Vaginal Bleeding | To compare the rates of vaginal bleeding from patients in estrogen group and no intervention group. As is standard in our practice, the pessary check visit includes an interview with the patient where specific self-reported symptoms are assessed. Participants will answer with self-reported yes/no during interview at the baseline study visit and at the final study visit. | Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting) | 
| Pessary Discomfort | To compare the degrees of pessary discomfort using visual analogue scale measured in millimeters between patients in estrogen group and no intervention group. On this scale, the value 1 reflects no complaints of this side-effect and 10 reflects very severe complaints of this side-effect. | Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting) | 
| Vaginal Discharge | To compare the degrees of bother of vaginal discharge using visual analogue scale measured in millimeters between patients in estrogen group and no intervention group. On this scale, the value 1 reflects no complaints of this side-effect and 10 reflects very severe complaints of this side-effect. | Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting) | 
| Urinary Tract Infection Rates | To compare the rates of urinary tract infections between patients in estrogen group and no intervention group. The diagnosis of urinary tract infection (UTI) is based on confirmatory testing, specifically with urine culture. | Final Visit (6 Months Post-Pessary Fitting) | 
| Vaginal Erosion Rates | To compare the rates of vaginal erosions between patients in estrogen group and no intervention group. Any vaginal erosions will be noted during the vaginal exam at the final visit, which is standard in our practice. Vaginal erosions are described using the following definitions: Type 0: No abnormalities; Type 1: Epithelial erythema; Type 2: Granulation tissue; Type 3: Epithelial break or erosion ≤ 1 cm; Type 4: Epithelial break or erosion > 1 cm. | Final Visit (6 Months Post-Pessary Fitting) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pessary, vaginal estradiol