Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
NCT01648751
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Adult Trials: 18+ Years
- 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
- 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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| 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 |
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| Study Arms ICMJE |
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| 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 | 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:
Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| 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 |
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| Investigators ICMJE |
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| 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 | |||||||||