NCT00789893

Study of Vaginal Dilator Use After Pelvic Radiotherapy

A Descriptive Study of Vaginal Dilator Use After Pelvic Radiotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 115 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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

• Cervical Cancer
• Endometrial Cancer
• Rectal Cancer
• Anal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2008-11-13
• Last updated: 2015-06-11

Locations

5 sites across 1 country: United States