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

Sponsor

Pamela Moalli (Other)

Overall Status

Recruiting

CT.gov ID

NCT01648751

Collaborator

American Urogynecologic Society (Other), National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), Pfizer (Industry)

Enrollment

Location

Arms

127

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Drug: Vaginal estrogen Drug: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaginal estrogen Patients in the experimental group will receive vaginal estrogen cream	Drug: Vaginal estrogen 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter Other Names: Premarin vaginal cream
Placebo Comparator: Placebo cream Patients in the comparison group will receive placebo vaginal cream	Drug: Placebo 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter Other Names: Placebo cream

Arm

Intervention/Treatment

Experimental: Vaginal estrogen

Patients in the experimental group will receive vaginal estrogen cream

Drug: Vaginal estrogen

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

Other Names:

Premarin vaginal cream

Placebo Comparator: Placebo cream

Patients in the comparison group will receive placebo vaginal cream

Drug: Placebo

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

Other Names:

Placebo cream

Outcome Measures

Primary Outcome Measures

Global impression of improvement in prolapse symptoms, using the PGI-I [6 months]
To determine the impact of vaginally delivered estrogen on global impression of improvement in women with symptomatic mild pelvic organ prolapse who are undergoing pelvic floor physical therapy

Secondary Outcome Measures

Pelvic floor symptoms, using the PFDI-20 [6 months]
Quality of life, using the PFIQ-7 [6 months]
Sexual function, using the PISQ-12 [6 months]
Pelvic organ prolapse stage, using the POP-Q exam [6 months]
Collagenase activity [6 months]
Vaginal swabs collected from the posterior fornix will be used for biochemical analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Magee-Womens Hospital, University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

Pamela Moalli
American Urogynecologic Society
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pfizer