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Pelvic Organ ProlapseEarly Phase 1NCT05458375

Vaginal Estradiol Use in Pessary Care

A Early Phase 1 study testing Estradiol vaginal cream in people with Pelvic Organ Prolapse and Urinary Incontinence, run by University of South Florida at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Estradiol vaginal cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
29 Dec 2022to 26 Apr 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of South Florida

    Tampa, Florida, 33606

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Estradiol vaginal cream
Keywords
pessary, vaginal estradiol
Medical subject headings
Pelvic Organ Prolapse, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estradiol vaginal creamDrug

    Also called Estrace, National Drug Code 0430-3754

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

Study groups in NCT05458375
Study groupRoleWhat they receive
Control GroupNo interventionParticipants 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 GroupExperimentalParticipants 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.
Receives: Drug: Estradiol vaginal cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pessary Discontinuation Rates

    To compare the rate of pessary discontinuation at 6 months post-pessary fitting in estrogen group and no intervention group

    Measured: 6 Months Post-Pessary Fitting

Secondary outcomes (7)

  1. 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

    Measured: 6 Months Post-Pessary Fitting

  2. Unscheduled office visits

    To compare the number of unscheduled office visits from patients in estrogen group and no intervention group

    Measured: 6 Months Post-Pessary Fitting

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

    Measured: Final Visit (6 Months Post-Pessary Fitting)

  7. 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.

    Measured: Final Visit (6 Months Post-Pessary Fitting)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2022
  2. Study start29 Dec 2022
  3. Primary completion26 Apr 2023
  4. Study completion26 Apr 2023

Why it stopped: There is a lack of potential study participants at our study site that would meet inclusion criteria, therefore, the study is not feasible and is being terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05458375
Sponsor's protocol ID
STUDY004394
Status last verified
Jun 2022
First submitted
11 Jul 2022
Last updated
11 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14981372

  • 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.

    PubMed 27942793

  • 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.

    PubMed 26992727

  • 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.

    PubMed 26537626

  • 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.

    PubMed 31809432

  • 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.

    PubMed 29901374

  • 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.

    PubMed 10831995

  • 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.

    PubMed 29705767

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Estradiol vaginal cream in people with Pelvic Organ Prolapse and Urinary Incontinence, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: There is a lack of potential study participants at our study site that would meet inclusion criteria, therefore, the study is not feasible and is being terminated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pessary Discontinuation Rates (time frame: 6 Months Post-Pessary Fitting). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05458375, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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