MedTrace Logo

Study of Vaginal Dilator Use After Pelvic Radiotherapy

NCT00789893 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 115

Last updated 2015-06-11

No results posted yet for this study

Summary

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

Interventions

DEVICE

Vaginal Dilator

Participants will be instructed to use the dilators 3 times per week, regardless of frequency of sexual intercourse. At 5 time points, data will be collected to determine vaginal dilator size, grade vaginal stenosis \& assess vaginal symptoms. 1)Baseline: patient self-assessment following consultation up until the end of the first week of radiation 2)Post-radiation: patient self-assessment one month ± 2 weeks follow-up from last day of radiation 3)Post-radiation: 3 month ± 4 weeks follow-up from initiation of dilator use 4)Post-radiation: 6 month ± 4 weeks follow-up from initiation of dilator use 5)Post-radiation: 12 months ± 4 weeks follow-up from initiation of dilator use. At the 1st \& 2nd time points, the nurse will telephone the patient to retrieve her responses. The 1st phone call will occur between the time following consultation up until the end of the first week of radiation, \& the 2nd will be one month ± 2 weeks from last day of radiation.

Sponsors & Collaborators

Principal Investigators

  • Ethel Law, MA, RN, OCN · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00789893 on ClinicalTrials.gov