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

NCT01648751

Last updated date
Study Location
Magee-Womens Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Contact
323-857-2238

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pelvic Organ Prolapse
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Pelvic Organ ProlapseVaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
NCT01648751
  1. Pittsburgh, Pennsylvania
Female
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
Official Title  ICMJE Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Organ Prolapse
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2012)
53
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura C Skoczylas, MD, MS323-857-2238[email protected]
Contact: Pamela Moalli, MD, PhD[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01648751
Other Study ID Numbers  ICMJE PRO09090064
R01HD061811 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pamela Moalli, University of Pittsburgh
Study Sponsor  ICMJE Pamela Moalli
Collaborators  ICMJE
  • American Urogynecologic Society
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Pfizer
Investigators  ICMJE
Study Director:Laura C Skoczylas, MD, MSUniversity of Pittsburgh
Principal Investigator:Pamela Moalli, MD, PhDUniversity of Pittsburgh
PRS Account University of Pittsburgh
Verification Date March 2020

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