Status:

NOT_YET_RECRUITING

Vaginal Dilator Therapy After Pelvic Radiation

Lead Sponsor:

Duke University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Pelvic Radiotherapy

Vaginal Stenosis

Eligibility:

FEMALE

18+ years

Phase:

NA

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 vagi...

Detailed Description

This study is testing a new behavioral program to help women who have had pelvic radiation therapy use vaginal dilators more regularly. Vaginal dilators are important tools that help prevent or treat ...

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

Key Trial Info

Start Date :

August 1 2027

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2030

Estimated Enrollment :

88 Patients enrolled

Trial Details

Trial ID

NCT07216456

Start Date

August 1 2027

End Date

April 30 2030

Last Update

October 15 2025

Active Locations (1)

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1

Duke University Medical Center

Durham, North Carolina, United States, 27710