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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 October 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: October 5, 2016
Last verified: October 2016

July 19, 2012
October 5, 2016
May 2012
December 2018   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01648751 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
Not Provided
Not Provided
 
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pelvic Organ Prolapse
  • Drug: Vaginal estrogen
    1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
    Other Name: Premarin vaginal cream
  • Drug: Placebo
    1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
    Other Name: Placebo cream
  • Experimental: Vaginal estrogen
    Patients in the experimental group will receive vaginal estrogen cream
    Intervention: Drug: Vaginal estrogen
  • Placebo Comparator: Placebo cream
    Patients in the comparison group will receive placebo vaginal cream
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
53
December 2019
December 2018   (final data collection date for primary outcome measure)

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)
Female
40 Years to 80 Years   (Adult, Senior)
No
Contact: Laura C Skoczylas, MD, MS 323-857-2238 lauraskoczylas@gmail.com
Contact: Pamela Moalli, MD, PhD moalpa@mail.magee.edu
United States
 
NCT01648751
PRO09090064, R01HD061811
Yes
Not Provided
Not Provided
University of Pittsburgh
University of Pittsburgh
  • American Urogynecologic Society
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Pfizer
Study Director: Laura C Skoczylas, MD, MS University of Pittsburgh
Principal Investigator: Pamela Moalli, MD, PhD University of Pittsburgh
University of Pittsburgh
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP