TerminatedPhase 4

Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse

Stopped: Collaborator moved and not able to recreate full study team

United States7 participantsStarted 2013-06-06

Plain-language summary

Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.

Who can participate

Age range

21 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 21 to 70 years of age * Stage II or greater pelvic organ prolapse (POP) * Individuals electing surgery to treat their POP * Willing and able to comply with study procedures * Willing and able to provide written informed consent Exclusion Criteria: * Contraindication for estrogen cream * Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation * History of connective tissue disease * Previous hysterectomy or pelvic organ prolapse surgery * Known allergic reaction to any agent required by the protocol * Use of hormone therapy in postmenopausal women in the last 90 days * Pregnant or lactating females * History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vaginal Epithelial Thickness

Timeframe: Change in thickness visit 1 to visit 2 for the postmenopausal group (approximately 1 month apart), and change in thickness from follicular to luteal phase for premenopausal group (approximately 1 month apart).

Trial details

NCT IDNCT01886794

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-11

Results submitted2025-02-11

View on ClinicalTrials.gov More Pelvic Floor Disorders trials