Vaginal Dilator Therapy After Pelvic Radiation
Official title: Improving Engagement With Vaginal Dilator Therapy After Pelvic Radiation: A Pilot Randomized Controlled Trial
Run by Duke University · NCT07216456 · Data updated 2026-11-12
This study tests a new behavioral program to help women who had pelvic radiation use vaginal dilators more regularly.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 130 (estimated) |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | March 5, 2026 |
| Main results expected | May 31, 2030 |
| Study ends | July 31, 2030 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07216456 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 and older who completed pelvic radiation in the past year and were prescribed vaginal dilator therapy, able to read and speak English.
✕Probably not a fit
Patients who do not use dilators regularly or who do not experience vaginal stenosis may see no personal benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will first gather input from patients and providers to shape a behavioral program, then refine it with user testing. In the final phase, 88 participants will be randomized to receive either the new program or written educational materials. The goal is to see if the program improves regular use of vaginal dilators to prevent or treat vaginal stenosis after pelvic radiation. The study uses approaches from cognitive behavioral therapy and acceptance and commitment therapy, guided by health behavior theory. Participation requires English-speaking adult women who recently completed pelvic radiation and were prescribed dilator therapy.
Why it matters
Potential benefit: If successful, the program could help more patients regularly use dilators, potentially reducing vaginal stenosis and improving comfort during exams and sexual activity.
How similar studies have gone: Previous behavioral programs and educational materials have shown promise in improving treatment adherence in other cancer care contexts, but this exact approach is being tested here for vaginal dilator use after pelvic radiation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Duke University Medical Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Juliann Stalls, PhD — Duke University
- Study coordinator: Smrithi Divakaran, MPH
- Email: smrithi.divakaran@duke.edu
- Phone: 919-681-7695
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.