Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pamela Moalli; University of Pittsburgh
• Collaborators: American Urogynecologic Society; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); Pfizer
• Treatments: Estrogens

Criteria

Inclusion Criteria:

• Women in good health aged 40-80

• Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:

Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?

• Meets POP-Q criteria on exam for stage I, II, or III prolapse

• Interested in PFPT for management of POP

• Normal mammogram within 1 year of enrollment

Exclusion Criteria:

• Prior surgery for prolapse or incontinence

• Other prior interventions for prolapse (e.g. pessary, PFPT)

• Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)

• Known liver dysfunction

• Connective tissue diseases known to affect collagen or elastin remodeling (including:

Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)

• Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year

• BMI > 35 kg/m2

• Estrogen therapy (including birth control) in the previous year

• Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal)

• Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)