Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
Vaginal estrogen
+ Placebo
Prolapse+1
+ Pathological Conditions, Signs and Symptoms
+ Pathological Conditions, Anatomical
Treatment Study
Summary
Study start date: May 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 40 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Magee-Womens Hospital, University of Pittsburgh
Pittsburgh, United StatesOpen Magee-Womens Hospital, University of Pittsburgh in Google Maps