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
Recruitment status was Recruiting
Sponsor:
University of Pittsburgh
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
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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
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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
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:
|
Pelvic Organ Prolapse Prolapse Pathological Conditions, Anatomical Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 02, 2015