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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Colorado, Denver
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
First received: July 26, 2011
Last updated: December 3, 2015
Last verified: December 2015
This study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.

Stenosis of Vagina

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Observation of a change in vaginal length from baseline measurement [ Time Frame: Outcomes will be measured at baseline, for patients in the radiation group this will be prior to any ] [ Designated as safety issue: No ]
    Based on prior studies we expect that women who receive pelvic radiation therapy and are noncompliant with dilator use will have a ≥1cm decrease in vaginal length. Observation of change in sexual function/satisfaction or increase in sexual discomfort compared to prior to treatment as measured by the Sexual Adjustment Questionnaire (SAQ)

Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Pelvic Malignancies
Women with Vaginal Stenosis

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women being treated for pelvic malignancies in the primary care clinic.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404728

Contact: Christine Fisher, MD 720-848-0696 Christine.Fisher@ucdenver.edu

United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Monica Robischon, RN    720-848-0661    Monica.Robischon@ucdenver.edu   
Sub-Investigator: Emma C. Fields, MD         
Principal Investigator: Christine Fisher, MD         
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Christine Fisher, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01404728     History of Changes
Other Study ID Numbers: 11-0454.cc 
Study First Received: July 26, 2011
Last Updated: December 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Vaginal length
Sexual dysfunction

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 10, 2016