Vaginal Dilator Therapy After Pelvic Radiation

This study is testing a new program called "Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation" to help women use vaginal dilators more consistently after pelvic radiation therapy. Pelvic radiation can sometimes cause vaginal narrowing (vaginal stenosis), which dilators help prevent or treat. The program uses coping strategies like relaxation and mindfulness, along with education on how to use dilators. You might be able to join if you are an adult woman (18 or older) who has completed pelvic radiation for certain cancers in the past year, has been recommended dilator therapy, and can speak English. The study will look at how easy the program is to complete and how acceptable it is to participants over 3 months. The current status of the study is unclear.

Study design
This study is an interventional study with a planned enrollment of 130 participants. It will involve developing and refining the program through interviews before testing it with a larger group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months after starting the program to assess feasibility and acceptability.

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NCT07216456

Vaginal Dilator Therapy After Pelvic Radiation

Recruiting
NAAges 18+InterventionalSupportive care
Duke University
~130 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility, as Measured by Session Completion and Attrition
Measured over 3 months post-baseline
+1 more outcome measured
Pelvic Radiotherapy
Vaginal Stenosis
Pelvic Cancer
Gynecologic Cancers
Anorectal Cancer
Urologic Cancer
1 sites across 1 states
North Carolina1
  • Juliann Stalls, PhD · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

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

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
  • Feasibility, as Measured by Session Completion and Attrition3 months post-baseline

    Feasibility will be determined by 1) greater than or equal to 80% of sessions completed and 2) attrition rate of less than or equal to 20%.

  • Acceptability, as Measured by the Treatment Acceptability Questionnaire3 months post-baseline

    Acceptability will be determined by average score of 5 or greater on the Treatment Acceptability Questionnaire (TAQ). The TAQ is a six-item measure assessing perceptions of an interventions acceptability, ethics, and effectiveness. Items are rated on a 7-point Likert scale, from "very unacceptable" to "very acceptable".