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Completed

NCT Number: NCT01404728

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

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

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Key information

Conditions

Malignancies Genital Diseases Neoplasms Sexual Dysfunction, Physiological Stenosis of Vagina Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Primary outcomes

  1. Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator)

    Time frame: 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.

  2. Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy

Important dates

Study start
2013
Primary completion
2013
Study completion
2017
First posted
Jul 28, 2011
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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