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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
American Urogynecologic Society
Magee-Womens Research Institute
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01648751
First received: July 19, 2012
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Drug: Vaginal estrogen
Drug: Placebo cream

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:


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 ]

Estimated Enrollment: 53
Study Start Date: May 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaginal estrogen 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 Drug: Placebo cream
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women in good health aged 40-60
  • 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 or II 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 a pap smear showing atypical glandular cells, ASCUS, LGSIL, or HGSIL in the previous year
  • BMI > 35 kg/m2
  • Estrogen therapy (including birth control) in the previous year (patients using progesterone alone will be included)
  • 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 412-641-7850 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
Magee-Womens Research Institute
Pfizer
Investigators
Study Director: Laura C Skoczylas, MD, MS University of Pittsburgh
Principal Investigator: Pamela Moalli, MD, PhD University of Pittsburgh
  More Information

No publications provided

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: July 23, 2012
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014