Vaginal Estradiol Use in Pessary Care

NCT ID: NCT05458375

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-29
• Study Completion Date: 2023-04-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Estradiol vaginal cream

Intervention Type: DRUG

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

Interventions

Estradiol vaginal cream

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

Intervention Type: DRUG

Other Intervention Names

Estrace; National Drug Code 0430-3754

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandra N Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

Tampa, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14981372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27942793 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26992727 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26537626 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31809432 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29901374 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10831995 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29705767 (View on PubMed)

Other Identifiers

STUDY004394

Identifier Type: -

Identifier Source: org_study_id