Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 2/10/2019 |
| Start Date: | May 2012 |
| End Date: | December 2020 |
| Contact: | Laura C Skoczylas, MD, MS |
| Email: | lauraskoczylas@gmail.com |
| Phone: | 323-857-2238 |
Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
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.
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.
The pathogenesis of pelvic organ prolapse (POP) is unknown. Few studies have correlated
patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed
with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following
Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to
treat prolapse symptoms, with little evidence supporting a clinical benefit. The
investigators hypothesize that the optimal approach to improving prolapse symptoms in the
patient with mild prolapse requires re-alignment and strengthening of levator muscles via
PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators
propose to test this hypothesis in a randomized controlled trial in which women with
symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with
vaginal estrogen versus placebo. The investigators predict that the combined approach will
lead to decreased symptoms and improved anatomical support corroborated by biomarker data.
patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed
with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following
Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to
treat prolapse symptoms, with little evidence supporting a clinical benefit. The
investigators hypothesize that the optimal approach to improving prolapse symptoms in the
patient with mild prolapse requires re-alignment and strengthening of levator muscles via
PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators
propose to test this hypothesis in a randomized controlled trial in which women with
symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with
vaginal estrogen versus placebo. The investigators predict that the combined approach will
lead to decreased symptoms and improved anatomical support corroborated by biomarker data.
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)
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