Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia
Dyspareunia
About this trial
This is an interventional supportive care trial for Dyspareunia focused on measuring Painful Intercourse, Sexual Dysfunction, Vaginal Dilator, Vaginal Moisturizer
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years or older
- English or Spanish speaking
Patients currently or previously treated for:
- Gynecologic cancer (surgery, chemotherapy, adjuvant vaginal brachytherapy)
- Breast cancer (chemotherapy, aromatase inhibitors, or selective estrogen receptor modulators; surgical menopause)
- Current desire for penetrative sexual activity
Endorsement of at least one of the following in the last 6 months:
- Dyspareunia during penetrative sexual activity
- Reported sensation of penetrative object (partner's penis, sex toy) not fitting in the vagina
- Avoidance of penetrative sexual activity due to fear of pain
- Physically able to insert a vaginal dilator by themselves
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with prior primary or upfront pelvic radiation
- Patients with whole pelvic radiation at any time
- Patients with a history of chronic pelvic pain
- Patients with vulvodynia as noted on baseline pelvic exam with > 5/10 pain score during an external exam with a cotton swab
- Patients with prior vaginal dilator use for any indication
Sites / Locations
- Columbia University Irving Medical Center / NewYork-Presbyterian HospitalRecruiting
- Women & Infants Hospital of Rhode Island / Brown University
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Vaginal Dilator Intervention
Control (Vaginal Moisturizer Only)
Patients assigned to the vaginal dilator group will be provided the device, vaginal moisturizer, an adherence calendar, and standardized verbal and written instructions from a trained health professional to apply the moisturizer and use the dilator for 15 minutes daily. Standard medical grade vaginal dilators and pure Vitamin E oil will be provided for each study participant. They have the option of purchasing a dilator and/or moisturizer of a similar nature if they choose to.
Patients assigned to vaginal moisturizer alone will receive pure Vitamin E oil and similar standardized instructions on daily use and an adherence calendar. They will apply a dime-sized amount of Vitamin E oil every day. They have the option of purchasing their own moisturizer if they choose to.