Vaginal Estradiol Use in Pessary Care

NCT05458375 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY004394
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pessary; vaginal estradiol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Phone calls/messages

  6 Months Post-Pessary Fitting

• Unscheduled office visits

  6 Months Post-Pessary Fitting

• Vaginal Bleeding

  Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting)

• Pessary Discomfort

  Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting)

• Vaginal Discharge

  Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting)

Study Arms (2)

Control Group

NO INTERVENTION

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

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

Interventions

Estradiol vaginal cream DRUG

Insert pea-sized amount of vaginal estradiol cream into vagina nightly for first two weeks and then twice weekly thereafter.

Also known as: Estrace, National Drug Code 0430-3754

Estrogen Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Postmenopausal status
• Recent pessary fitting
• Office-based and home-based pessary care

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33606, United States

Location

Related Publications (8)

• 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.

  PMID: 14981372 BACKGROUND

• 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.

  PMID: 27942793 BACKGROUND

• 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.

  PMID: 26992727 BACKGROUND

• 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.

  PMID: 26537626 BACKGROUND

• 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.

  PMID: 31809432 BACKGROUND

• 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.

  PMID: 29901374 BACKGROUND

• 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.

  PMID: 10831995 BACKGROUND

• 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.

  PMID: 29705767 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Alexandra N Garcia, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: December 29, 2022
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: May 11, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)