Clinical trial · Observational
Study of Vaginal Dilator Use After Pelvic Radiotherapy
A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy
- 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)
Patient will have radiation to treat the cancer. This treatment can make the vagina both narrower and shorter. That can cause two problems. It can make it harder for the doctor to do a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable. We tell women to use a vaginal dilator after radiation to the pelvis. This is standard education. We do not routinely ask women how they do with it. We are doing this study to see if using the dilator as we instruct will help the vagina stretch. The patient will have an examine of the vagina before the start of radiation. We will see what size dilator can fit. The goal of this study is to have the patient be able to use that size dilator within six months after radiation.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaginal Dilator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with cervical, endometrial, rectal or anal cancer
- description
- Women seen in the radiation oncology clinic with cervical, endometrial, rectal or anal cancer who will receive external beam pelvic radiation or brachytherapy
- interventionNames
- Device: Vaginal Dilator
Primary outcomes (2)
- measure
- To measure compliance with vaginal dilator use.
- timeFrame
- conclusion of study
- measure
- To examine the effect of dilator use in minimizing vaginal stenosis so that patients are able to use the pre-radiation baseline dilator size 6 months after starting dilator use.
- timeFrame
- conclusion of study
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Female with cervical, endometrial, rectal or anal cancer * Scheduled to begin one of the following treatments at MSKCC: * Definitive external beam radiation therapy * Preoperative external beam radiation therapy of followed by surgery * Postoperative external beam radiation therapy * Definitive external beam radiation therapy with intracavitary brachytherapy (tandem and ring or Syed)± surgery * Postoperative intravaginal brachytherapy (once every two weeks times three) * ≥ or = to 21 years of age Exclusion Criteria: * Women with cervical, endometrial, rectal or anal cancer who are/have: * Unable to speak and write English so that it would prohibit them from full participation in the study. Patient education, instruction and questionnaire are validated in English. * Mental or physical handicaps that would prohibit them from full participation in the study. * Prior radiation to the pelvis. * Evidence of metastatic disease.
References
Publications (0)
Data not yet available