Clinical trial NCT01648751: Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
Official title: Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Pelvic floor physical therapy
Vaginal estrogen
Placebo
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Urogynecologic Society
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Pfizer
First posted: 2012-07-24
Enrollment: 21
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Patient Global Impression of Improvement
timeFrame: 6 months after starting vaginal cream
Secondary outcomes:
measure: Pelvic Floor Symptoms
timeFrame: 6 months
measure: General Quality of Life
timeFrame: 6 months
measure: Pelvic Organ Prolapse Stage
timeFrame: 6 months
measure: Collagenase Activity
timeFrame: 6 months
measure: Sexual Function
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital, University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Laura C Skoczylas, MD, MS
role: STUDY_DIRECTOR
affiliation: University of Pittsburgh
name: Pamela Moalli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: