Longitudinal Evaluation Study of Vaginal Stenosis With and Without Pelvic Radiation Therapy

Completed

• Conditions: Malignancies; Stenosis of Vagina

• Registration Number: NCT01404728
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Study Start: 2013-01-08
• Primary Completion: 2013-01-22
• Study Completion: 2017-03-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Pre and post menopausal women undergoing definitive (not palliative) treatments for a pelvic malignancy, including rectal, endometrial, cervical, or anal canal carcinoma.
• Treatments include radiation therapy, chemotherapy, surgery, or a combination of therapies.
• May have early-stage or locally advanced (node positive) disease.
• Male partners of the female subjects are also consented for this study.

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Exclusion Criteria

• Subject may not have evidence of metastatic disease.
• Prior pelvic radiation therapy
• Prior hysterectomy (not for current diagnosis)
• Diagnosis of prior malignancy, except non-melanoma skin cancer.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator)	Up to 24 Months	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.
Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)	Up to 24 Months	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.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States