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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Pittsburgh
Sponsor:
Collaborators:
American Urogynecologic Society
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01648751
First received: July 19, 2012
Last updated: January 27, 2016
Last verified: January 2016
History of Changes
  Purpose
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 Intervention
Pelvic Organ Prolapse
 Drug: Vaginal estrogen
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Global impression of improvement in prolapse symptoms, using the PGI-I [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life, using the PFIQ-7 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Sexual function, using the PISQ-12 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pelvic organ prolapse stage, using the POP-Q exam [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Collagenase activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Vaginal swabs collected from the posterior fornix will be used for biochemical analysis
Estimated Enrollment: 53
Study Start Date: May 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo cream

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
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648751

Contacts
Contact: Laura C Skoczylas, MD, MS 323-857-2238 lauraskoczylas@gmail.com
Contact: Pamela Moalli, MD, PhD moalpa@mail.magee.edu

Locations
United States, Pennsylvania
Magee-Womens Hospital, University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lori Geraci, BS    412-641-2634      
Sub-Investigator: Laura C Skoczylas, MD, MS         
Principal Investigator: Pamela Moalli, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
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
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01648751     History of Changes
Other Study ID Numbers: PRO09090064  R01HD061811 
Study First Received: July 19, 2012
Last Updated: January 27, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
Pelvic organ prolapse
Pelvic floor physical therapy
Vaginal estrogen
Placebo

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016