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Collaborator moved and not able to recreate full study team
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Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. We will perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and overall mucosal health prior to surgery. At the time of surgery, we will obtain tissue for histologic and imaging analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postmenopausal, topical vaginal cream | Experimental | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream. |
|
| Pre-menopausal, no topical vaginal cream | No Intervention | Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints. | |
| Postmenopausal, topical placebo cream | Placebo Comparator | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postmenopausal, topical vaginal estrogen cream | Drug | Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Epithelial Thickness | Measure of vaginal epithelial thickness obtained by optical coherence tomography | Change in thickness visit 1 to visit 2 for the postmenopausal group (approximately 1 month apart), and change in thickness from follicular to luteal phase for premenopausal group (approximately 1 month apart). |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic Assessment of Excised Tissue | Evaluated tissue samples obtained during surgery to examine collagen. Collagen score (Masson trichrome): 3=abundant collagen (dark blue stain), 2=collagen present (light blue stain), 1=scant collagen (minimal blue stain) Higher scores indicate more collagen, or better outcome. (note that study vaginal drug was stopped at visit 2 for postmenopausal subjects except in one subject who used active topical vaginal cream but stopped after 2 weeks due to AE. Her OCT score was obtained after 2 weeks of active cream, however the histology was obtained 2 weeks after discontinuation of study drug because Visit 2 was scheduled at the time of the AE and at the time of stopping the active cream. The OCT and histology results are not concordant due to being taken at different timepoints (visit 2 on active cream vs surgery 16 days later off cream) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Vincent, MD | UTMB Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTMB Galveston | Galveston | Texas | 77550 | United States |
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| Label | URL |
|---|---|
| Link to the clinic where recruitment will be performed | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Postmenopausal, Topical Vaginal Cream | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream. Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse. |
| FG001 | Pre-menopausal, no Topical Vaginal Cream | Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints. |
| FG002 | Postmenopausal, Topical Placebo Cream | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo. Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Postmenopausal, Topical Vaginal Cream | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream. Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse. |
| 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 | Vaginal Epithelial Thickness | Measure of vaginal epithelial thickness obtained by optical coherence tomography | All participants who enrolled were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | micrometers | Change in thickness visit 1 to visit 2 for the postmenopausal group (approximately 1 month apart), and change in thickness from follicular to luteal phase for premenopausal group (approximately 1 month apart). |
|
AE's were collected during the time the subjects were enrolled in the study, which was 4-6 weeks.
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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 | Postmenopausal, Topical Vaginal Cream | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream. Postmenopausal, topical vaginal estrogen cream: Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vulvovaginal discomfort/itching | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen L. Vincent, M.D. | University of Texas Medical Branch | 409-772-2610 | klvincen@utmb.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 | Nov 22, 2021 | Jan 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2021 | Jan 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
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|
|
| Placebo Comparator: Postmenopausal, topical placebo cream | Drug | Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery. |
|
|
| 1 month after visit 1 (3-17days after visit 2) |
| BG001 | Pre-menopausal, no Topical Vaginal Cream | Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints. |
| BG002 | Postmenopausal, Topical Placebo Cream | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo. Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Pre-menopausal, no Topical Vaginal Cream | Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints. |
| OG002 | Postmenopausal, Topical Placebo Cream | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo. Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery. |
|
|
| Secondary | Histologic Assessment of Excised Tissue | Evaluated tissue samples obtained during surgery to examine collagen. Collagen score (Masson trichrome): 3=abundant collagen (dark blue stain), 2=collagen present (light blue stain), 1=scant collagen (minimal blue stain) Higher scores indicate more collagen, or better outcome. (note that study vaginal drug was stopped at visit 2 for postmenopausal subjects except in one subject who used active topical vaginal cream but stopped after 2 weeks due to AE. Her OCT score was obtained after 2 weeks of active cream, however the histology was obtained 2 weeks after discontinuation of study drug because Visit 2 was scheduled at the time of the AE and at the time of stopping the active cream. The OCT and histology results are not concordant due to being taken at different timepoints (visit 2 on active cream vs surgery 16 days later off cream) | Histology was performed for the postmenopausal, topical vaginal cream, and the pre-menopausal, no topical vaginal cream group. There was no histology available from the 2 postmenopausal subjects randomly assigned to the placebo cream group. | Posted | Mean | Standard Deviation | score on a scale | 1 month after visit 1 (3-17days after visit 2) |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Pre-menopausal, no Topical Vaginal Cream | Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Postmenopausal, Topical Placebo Cream | Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo. Placebo Comparator: Postmenopausal, topical placebo cream: Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery. | 0 | 2 | 0 | 2 | 1 | 2 |
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| D052801 | Male Urogenital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |