- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01648751
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
February 7, 2023 updated by: Pamela Moalli
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Laura C Skoczylas, MD, MS
- Phone Number: 323-857-2238
- Email: lauraskoczylas@gmail.com
Study Contact Backup
- Name: Pamela Moalli, MD, PhD
- Email: moalpa@mail.magee.edu
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- Magee-Womens Hospital, University of Pittsburgh
-
Contact:
- Lori Geraci, BS
- Phone Number: 412-641-2634
-
Sub-Investigator:
- Laura C Skoczylas, MD, MS
-
Principal Investigator:
- Pamela Moalli, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vaginal estrogen
Patients in the experimental group will receive vaginal estrogen cream
|
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
Other Names:
|
PLACEBO_COMPARATOR: Placebo cream
Patients in the comparison group will receive placebo vaginal cream
|
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global impression of improvement in prolapse symptoms, using the PGI-I
Time Frame: 6 months
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic floor symptoms, using the PFDI-20
Time Frame: 6 months
|
6 months
|
|
Quality of life, using the PFIQ-7
Time Frame: 6 months
|
6 months
|
|
Sexual function, using the PISQ-12
Time Frame: 6 months
|
6 months
|
|
Pelvic organ prolapse stage, using the POP-Q exam
Time Frame: 6 months
|
6 months
|
|
Collagenase activity
Time Frame: 6 months
|
Vaginal swabs collected from the posterior fornix will be used for biochemical analysis
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Laura C Skoczylas, MD, MS, University of Pittsburgh
- Principal Investigator: Pamela Moalli, MD, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (ANTICIPATED)
December 1, 2023
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
July 19, 2012
First Submitted That Met QC Criteria
July 23, 2012
First Posted (ESTIMATE)
July 24, 2012
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO09090064
- R01HD061811 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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