Vaginal Dilator Therapy After Pelvic Radiation

Recruiting now · Not applicable

Conditions studied: Pelvic Radiotherapy, Vaginal Stenosis, Pelvic Cancer, Gynecologic Cancers, Anorectal Cancer, Urologic Cancer

In brief

This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or sexual activity painful or difficult. Even though dilators are recommended, many women don't use them as often as needed. In Phase I of the study, individual qualitative interviews with patients in the target sample (N=20) and medical providers (N=10) will be used to inform the behavioral program development. In Phase II, the program will be refined through user testing interviews (N=12). In Phase III, 88 participants will be randomly assigned to one of two groups: * One group will receive the new behavioral program, which includes support and strategies to help with regular dilator use. * The other group will receive written educational materials (enhanced usual care). The study will look at how often and how long participants use their dilators, and whether the program helps reduce symptoms like pain or emotional distress. Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months, plus short monthly check-ins. The goal is to see if the program is helpful and easy to use, and to prepare for a larger study in the future.

Key facts

Study ID

NCT07216456

Run by

Duke University

People needed

130

Starts

2026-03-05

Expected to finish

2030-07-31

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• female sex
• adults aged 18 years or older
• diagnosed with cancer of the anus, anal canal, anorectum, cervix, uterus, vagina, vulva, and/or bladder
• completed pelvic radiation therapy in the past year
• dilator therapy recommended by medical provider and standardized dilator received from provider
• able to speak/read English

You may not qualify if…

• aged less than 17 years
• under the care of a pelvic floor physical therapist at the time of study enrollment
• have a major/serious psychiatric concern (e.g., schizophrenia) as indicated by medical chart/medical provider
• inability to provide consent

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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