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

NCT01404728 | Completed DMC

• 1 other identifier: 11-0454.cc
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignancies; Stenosis of Vagina

Keywords

Vaginal length; Sexual dysfunction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Pelvic Malignancies

Women with Vaginal Stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women being treated for pelvic malignancies in the primary care clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Christine Fisher, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 28, 2011
• Study Start: January 8, 2013
• Primary Completion: January 22, 2013
• Study Completion: March 1, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)