NCT07216456 Vaginal Dilator Therapy After Pelvic Radiation
| NCT ID | NCT07216456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Pelvic Radiotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-03-05 |
| Primary Completion | 2030-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2026-03-05 with a primary completion date of 2030-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Juliann Stalls, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07216456 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pelvic Radiotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07216456 currently recruiting?
Yes, NCT07216456 is actively recruiting participants. Contact the research team at smrithi.divakaran@duke.edu for enrollment information.
Where is the NCT07216456 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07216456 clinical trial?
NCT07216456 is sponsored by Duke University. The principal investigator is Juliann Stalls, PhD at Duke University. The trial plans to enroll 130 participants.