Vaginal Estradiol Use in Pessary Care

University of South Florida

Status and phase: Terminated; Early Phase 1

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

Treatments: Drug: Estradiol vaginal cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05458375

STUDY004394

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Control Group

No Intervention group

Description:

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.

Estrogen Group

Experimental group

Description:

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.

Treatment:

Drug: Estradiol vaginal cream