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The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.
Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premarin cream 0.5gm | Active Comparator | Application of 0.5gm of vaginal estrogen cream nightly until surgery. |
|
| Premarin cream 1.0gm | Active Comparator | Application of 1.0gm of vaginal estrogen cream nightly until surgery. |
|
| No intervention | No Intervention | Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal conjugated estrogen cream 0.5gm | Drug | Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains. | baseline and 2-12 weeks after treatment (at time of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology. | baseline and 2-12 weeks after treatment (at time of surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine M Vaccaro, DO | Good Samaritan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trihealth (Good Samaritan Hospital, Bethesda North Hospital) | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37431855 | Derived | Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D059268 | Atrophic Vaginitis |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| D004966 | Estrogens, Conjugated (USP) |
| ID | Term |
|---|---|
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
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| Vaginal conjugated estrogen cream 1.0gm | Drug | Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery. |
|
|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |