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)
53
Enrollment
1
Location
2
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

    1. 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

    1. Pelvic floor symptoms, using the PFDI-20 [6 months]

    2. Quality of life, using the PFIQ-7 [6 months]

    3. Sexual function, using the PISQ-12 [6 months]

    4. Pelvic organ prolapse stage, using the POP-Q exam [6 months]

    5. 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:
    No
    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

    SiteCityStateCountryPostal Code
    1Magee-Womens Hospital, University of PittsburghPittsburghPennsylvaniaUnited States15213

    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

    Investigators

    • Study Director: Laura C Skoczylas, MD, MS, University of Pittsburgh
    • Principal Investigator: Pamela Moalli, MD, PhD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pamela Moalli, Associate Professor, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT01648751
    Other Study ID Numbers:
    • PRO09090064
    • R01HD061811
    First Posted:
    Jul 24, 2012
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022
    Keywords provided by Pamela Moalli, Associate Professor, University of Pittsburgh
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2022