Clinical trial · Observational
Longitudinal Evaluation Study of Vaginal Stenosis With and Without Pelvic Radiation Therapy
Prospective Longitudinal Evaluation of Vaginal Stenosis and Sexual Function in Women With Pelvic Malignancies Treated With and Without Pelvic Radiation Therapy
NCT01404728CI-TRIAL-00027284completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignancies | — | UNRESOLVED | — |
| Stenosis of Vagina | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Pelvic Malignancies
- description
- Women with Vaginal Stenosis
Primary outcomes (2)
- measure
- Observation of a change in vaginal length as measured with a vaginal sound (modified vaginal dilator)
- timeFrame
- Up to 24 Months
- description
- 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.
- measure
- Observation of change in sexual function/satisfaction as measured by the Sexual Adjustment Questionnaire (SAQ)
- timeFrame
- Up to 24 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.