Vaginal Estradiol Use in Pessary Care

Urinary Incontinence Clinical Trial

Official title:

Vaginal Estradiol Use in Pessary Management: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05458375
• Other study ID #: STUDY004394
• Status: Terminated
• Phase: Early Phase 1
• Start date: December 29, 2022
• Est. completion date: April 26, 2023

Study information

• Verified date: June 2022
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence
• Vaginal Atrophy

Intervention

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

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. Erratum In: Int Urogynecol J. 2016 Sep;27(9):1431. — View 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. — View 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. Erratum In: Obstet Gynecol. 2021 Aug 1;138(2):313. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)