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This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.
Vaginal stenosis can occur as a result of treatment for pelvic malignancies. Women receiving pelvic radiation therapy using a vaginal dilator 5-7 times per week will have less vaginal stenosis than women using a vaginal dilator fewer times or not at all.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Malignancies | Women with Vaginal Stenosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator) | Observation of change in vaginal length will be measured at baseline (which for the patients in the radiation group will be prior to any pelvic radiation therapy and for patients in the surgery group this will be at the first post-operative visit), as well as in follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements. | Up to 24 Months |
| Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ) | The baseline SAQ will be administered prior to radiation therapy for the pelvic malignancy group and it will be administered at the post-operative visit for the surgery only group, and the post-treatment SAQ version will be given at the follow-up visits at 3, 6, 12, and 24 months for a total of 5 measurements. | Up to 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Women being treated for pelvic malignancies in the primary care clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Christine Fisher, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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