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Hormone Therapy
Vaginal Estrogen + Physical Therapy for Prolapse
N/A
Recruiting
Led By Pamela Moalli, MD, PhD
Research Sponsored by Pamela Moalli
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether adding vaginal estrogen to Pelvic Floor Physical Therapy (PFPT) can improve symptoms and support for women with mild pelvic organ prolapse.
Eligible Conditions
- Pelvic Organ Prolapse
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Global impression of improvement in prolapse symptoms, using the PGI-I
Secondary outcome measures
Collagenase activity
Pelvic floor symptoms, using the PFDI-20
Pelvic organ prolapse stage, using the POP-Q exam
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vaginal estrogenExperimental Treatment1 Intervention
Patients in the experimental group will receive vaginal estrogen cream
Group II: Placebo creamPlacebo Group1 Intervention
Patients in the comparison group will receive placebo vaginal cream
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Who is running the clinical trial?
Pamela MoalliLead Sponsor
American Urogynecologic SocietyOTHER
10 Previous Clinical Trials
669 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,535 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are interested in using PFPT (pelvic floor physical therapy) to manage pelvic organ prolapse (POP).You feel or see a bulge in your vagina or feel pressure in your vagina, which may be a sign of pelvic organ prolapse.You have been diagnosed with stage I, II or III prolapse based on a physical exam using the POP-Q criteria.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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