Clinical trial NCT05458375: Vaginal Estradiol Use in Pessary Care
Official title: Vaginal Estradiol Use in Pessary Management: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Pessary Ulcer of Vagina
Vaginal Atrophy
Keywords: pessary
vaginal estradiol
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pessary Discontinuation Rates
timeFrame: 6 Months Post-Pessary Fitting
Secondary outcomes:
measure: Phone calls/messages
timeFrame: 6 Months Post-Pessary Fitting
measure: Unscheduled office visits
timeFrame: 6 Months Post-Pessary Fitting
measure: Vaginal Bleeding
timeFrame: Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting)
measure: Pessary Discomfort
timeFrame: Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting)
measure: Vaginal Discharge
timeFrame: Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting)
measure: Urinary Tract Infection Rates
timeFrame: Final Visit (6 Months Post-Pessary Fitting)
measure: Vaginal Erosion Rates
timeFrame: Final Visit (6 Months Post-Pessary Fitting)
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Alexandra N Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.