Vaginal Dilator Therapy After Pelvic Radiation

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
This study is testing a new behavioral program to help women who have had pelvicradiation therapy use vaginal dilators more regularly. Vaginal dilators are importanttools that help prevent or treat vaginal stenosis‐a condition where the vagina becomesshorter or narrower after radiation. This can make medical exams and sexual activitypainful or difficult. Although dilators are commonly recommended, many women struggle touse them consistently.The new program is designed to support women in overcoming common challenges to usingdilators, such as pain, emotional distress, and lack of information. It includesstrategies from cognitive behavioral therapy and acceptance and commitment therapy, andis based on the Health Belief Model, which helps people understand how their beliefsaffect their health behaviors.In Phase I, individual qualitative interviews with patients in the target sample (N=20)and medical providers (N=10) will be used to inform behavioral program development. It isanticipated that the program will employ strategies from cognitive behavioral therapy andacceptance and commitment therapy. In Phase II, the program will be refined through usertesting interviews (N=12). In Phase III, 88 participants will be randomly assigned to oneof two groups: ‐ One group will receive the new behavioral program. ‐ The other group will receive written educational materials (enhanced usual care).Participants will complete surveys at the beginning of the study and again at 3, 6, and 9months. They will also complete short monthly check‐ins to report how often and how longthey use their dilators.The main goals of the study are to: ‐ See if the program is easy to use and acceptable to participants. ‐ Track how often participants use their dilators. ‐ Measure changes in symptoms, emotional distress, and knowledge about dilatortherapy.This pilot study will help researchers prepare for a larger study in the future andimprove support for women recovering from pelvic radiation.
Epistemonikos ID: 5de430e0fcb55f70d8798a1b83dd5306af933e90
First added on: Oct 15, 2025