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

Pamela Moalli

Status: Terminated

Conditions: Pelvic Organ Prolapse

Treatments: Drug: Placebo; Drug: Vaginal estrogen

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01648751

R01HD061811 (U.S. NIH Grant/Contract)

STUDY19030408

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

21 participants in 2 patient groups, including a placebo group

Vaginal estrogen

Experimental group

Description:

Patients in the experimental group will receive vaginal estrogen cream

Treatment:

Drug: Vaginal estrogen

Placebo cream

Placebo Comparator group

Description:

Patients in the comparison group will receive placebo vaginal cream

Treatment:

Drug: Placebo