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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD061811 | U.S. NIH Grant/Contract | View source |
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Insufficient recruitment
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| Name | Class |
|---|---|
| American Urogynecologic Society | OTHER |
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal estrogen | Experimental | Patients in the experimental group will receive vaginal estrogen cream |
|
| Placebo cream | Placebo Comparator | Patients in the comparison group will receive placebo vaginal cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal estrogen | Drug | 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Improvement | The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians. Potential Responses:
6. Much Worse 7. Very Much Worse Lower scores indicate more imiprovment / better outcome. | 6 months after starting vaginal cream |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Symptoms | Pelvic Floor Symptoms, using the PFDI-20. The Pelvic Floor Distress Inventory is a condition specific quality of life instrument that assesses distress from pelvic organ prolapse, colorectal-anal, and urinary symptoms. Higher scores indicate greater disease burden. Range: 0 to 300 | 6 months |
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Inclusion Criteria:
Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura C Skoczylas, MD, MS | University of Pittsburgh | Study Director |
| Pamela Moalli, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital, University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
One subject was ineligible prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaginal Estrogen | Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter |
| FG001 | Placebo Cream | Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaginal Estrogen | Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter |
| BG001 | Placebo Cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Global Impression of Improvement | The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians. Potential Responses:
6. Much Worse 7. Very Much Worse Lower scores indicate more imiprovment / better outcome. | Subjects who completed surveys at 6 months post treatment. | Posted | Mean | Full Range | score on a scale | 6 months after starting vaginal cream |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaginal Estrogen | Patients in the experimental group will receive vaginal estrogen cream Vaginal estrogen: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Moalli MD PHD | University of PIttsburgh | 412-641-6052 | moalpa@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2016 | Apr 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Pfizer |
| INDUSTRY |
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| Placebo | Drug | 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter |
|
|
| General Quality of Life |
Quality of Life, using the PFIQ-7 The Pelvic Floor Impact Questionnaire assesses how bladder, bowel, and vaginal symptoms affect activity, relationships, ad feelings. Higher numbers indicate greater disease burden. Score range: 0 to 300 |
| 6 months |
| Pelvic Organ Prolapse Stage | Pelvic Organ Prolapse Stage, using the POP-Q exam. The Pelvic Organ Prolapse Quantification System use 9 measurements in the vagina to assess prolapse stage. Higher stage indicates greater prolapse. Range: 0 to 4 | 6 months |
| Collagenase Activity | Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis. | 6 months |
| Sexual Function | Sexual Function, using the PISQ-12 The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire evaluates sexual function in patients with incontinence and/or vaginal prolapse. Higher scores indicate greater disease burden. Scale: 0 to 48 | 6 months |
Patients in the comparison group will receive placebo vaginal cream
Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Placebo Cream | Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter. The average score on the PGI-I at 6 months post treatment was 3.0. (N=7) A lower score indicates improvement. |
|
|
| Secondary | Pelvic Floor Symptoms | Pelvic Floor Symptoms, using the PFDI-20. The Pelvic Floor Distress Inventory is a condition specific quality of life instrument that assesses distress from pelvic organ prolapse, colorectal-anal, and urinary symptoms. Higher scores indicate greater disease burden. Range: 0 to 300 | Subjects who completed surveys at 6 months post treatment. | Posted | Mean | Full Range | score on a scale | 6 months |
|
|
|
| Secondary | General Quality of Life | Quality of Life, using the PFIQ-7 The Pelvic Floor Impact Questionnaire assesses how bladder, bowel, and vaginal symptoms affect activity, relationships, ad feelings. Higher numbers indicate greater disease burden. Score range: 0 to 300 | Subjects who completed surveys at 6 months post treatment. | Posted | Mean | Full Range | score on a scale | 6 months |
|
|
|
| Secondary | Pelvic Organ Prolapse Stage | Pelvic Organ Prolapse Stage, using the POP-Q exam. The Pelvic Organ Prolapse Quantification System use 9 measurements in the vagina to assess prolapse stage. Higher stage indicates greater prolapse. Range: 0 to 4 | Subjects who underwent POP-Q measurements at 6 months post treatment. | Posted | Mean | Full Range | units on a scale | 6 months |
|
|
|
| Secondary | Collagenase Activity | Collagenase Activity, via vaginal swabs collected from the posterior fornix will be used for biochemical analysis. | Data not available. Vaginal swabs were collected from participants. However, the lab was unable to analyze collagenase activity because there was not enough protein isolated from the samples. | Posted | 6 months |
|
|
| Secondary | Sexual Function | Sexual Function, using the PISQ-12 The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire evaluates sexual function in patients with incontinence and/or vaginal prolapse. Higher scores indicate greater disease burden. Scale: 0 to 48 | Subjects who completed surveys at 6 months post treatment. | Posted | Mean | Full Range | score on a scale | 6 months |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Placebo Cream | Patients in the comparison group will receive placebo vaginal cream Placebo: 1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter | 0 | 11 | 0 | 11 | 0 | 11 |
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