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Clinical Trials/NCT00053261
NCT00053261
Completed
Not Applicable

Vaginal Length, Elasticity, Lubrication And Sexual Function In Women With Stage IB2 Cervix Carcinoma

Gynecologic Oncology Group12 sites in 1 countryJuly 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
Gynecologic Oncology Group
Locations
12
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer.

PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.

Detailed Description

OBJECTIVES: * Obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage IB2 cervical cancer. * Compare these differences between the patients in the two treatment groups in GOG-0201. * Determine the relationships between vaginal dilation activities and vaginal length changes in these patients. * Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer. * Assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients. OUTLINE: Vaginal length is measured using Vaginal Sound, a modified plastic vaginal dilator. The data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. Measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.

Registry
clinicaltrials.gov
Start Date
July 2003
End Date
January 2007
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (12)

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