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

NCT ID: NCT01648751

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2023-03-02

Brief 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.

Detailed 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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vaginal estrogen

Patients in the experimental group will receive vaginal estrogen cream

Group Type: EXPERIMENTAL

Vaginal estrogen

Intervention Type: DRUG

1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

Placebo cream

Patients in the comparison group will receive placebo vaginal cream

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

Interventions

Vaginal estrogen

1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

Intervention Type: DRUG

Placebo

1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

Intervention Type: DRUG

Other Intervention Names

Premarin vaginal cream; Placebo cream

Eligibility 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Urogynecologic Society

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Pamela Moalli

OTHER

Sponsor Role: lead

Responsible Party

Pamela Moalli

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laura C Skoczylas, MD, MS

Role: STUDY_DIRECTOR

University of Pittsburgh

Pamela Moalli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee-Womens Hospital, University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HD061811

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19030408

Identifier Type: -

Identifier Source: org_study_id