Vaginal Estradiol Use in Pessary Care

Vaginal Estradiol Use in Pessary Management: A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Incontinence; Pelvic Organ Prolapse; Vaginal Atrophy; Pessary Ulcer of Vagina
• Intervention / Treatment: Drug: Estradiol vaginal cream

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Alexandra N Garcia, MD; Phone Number: 813-259-0814; Email: agarcia305@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
      • Contact: Alexandra N Garcia, MD; Phone Number: 813-974-5638; Email: agarcia305@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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; 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; Insert pea-sized amount of vaginal estradiol cream into vagina nightly for first two weeks and then twice weekly thereafter.; Other Names: Estrace; National Drug Code 0430-3754

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Alexandra N Garcia, MD, University of South Florida

Publications and helpful links

General Publications

• Cundiff GW, Weidner AC, Visco AG, Bump RC, Addison WA. A survey of pessary use by members of the American urogynecologic society. Obstet Gynecol. 2000 Jun;95(6 Pt 1):931-5. doi: 10.1016/s0029-7844(00)00788-2.
• Clemons JL, Aguilar VC, Tillinghast TA, Jackson ND, Myers DL. Risk factors associated with an unsuccessful pessary fitting trial in women with pelvic organ prolapse. Am J Obstet Gynecol. 2004 Feb;190(2):345-50. doi: 10.1016/j.ajog.2003.08.034.
• Wolff B, Williams K, Winkler A, Lind L, Shalom D. Pessary types and discontinuation rates in patients with advanced pelvic organ prolapse. Int Urogynecol J. 2017 Jul;28(7):993-997. doi: 10.1007/s00192-016-3228-9. Epub 2016 Dec 10.
• Dessie SG, Armstrong K, Modest AM, Hacker MR, Hota LS. Effect of vaginal estrogen on pessary use. Int Urogynecol J. 2016 Sep;27(9):1423-9. doi: 10.1007/s00192-016-3000-1. Epub 2016 Mar 18. Erratum In: Int Urogynecol J. 2016 Sep;27(9):1431.
• Bulchandani S, Toozs-Hobson P, Verghese T, Latthe P. Does vaginal estrogen treatment with support pessaries in vaginal prolapse reduce complications? Post Reprod Health. 2015 Dec;21(4):141-5. doi: 10.1177/2053369115614704. Epub 2015 Nov 3.
• Propst K, Mellen C, O'Sullivan DM, Tulikangas PK. Timing of Office-Based Pessary Care: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jan;135(1):100-105. doi: 10.1097/AOG.0000000000003580. Erratum In: Obstet Gynecol. 2021 Aug 1;138(2):313.
• Tontivuthikul P, Sanmee U, Wongtra-Ngan S, Pongnarisorn C. Effect of Local Estrogen Cream on Vaginal Health after Pessary Use for Prolapsed Pelvic Organ: A Randomized Controlled Trial. J Med Assoc Thai. 2016 Jul;99(7):757-63.
• Lough K, Hagen S, McClurg D, Pollock A; JLA Pessary PSP Steering Group. Shared research priorities for pessary use in women with prolapse: results from a James Lind Alliance Priority Setting Partnership. BMJ Open. 2018 Apr 28;8(4):e021276. doi: 10.1136/bmjopen-2017-021276.

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: pessary; vaginal estradiol
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Estradiol
• Other Study ID Numbers: STUDY004394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes