Clinical trial · Interventional
Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia
The Impact of Vaginal Dilator Therapy on Pain Scores and Sexual Function Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study was stopped as Fellow was unable to committ to enrollment and study due to time constraints
Summary
Brief summary (as posted)
In this randomized controlled trial, the investigators will assess the difference in mean patient-reported pain scores and sexual function between women with gynecologic or breast cancers experiencing dyspareunia (painful intercourse) who are assigned to vaginal dilator use with vaginal moisturizer (Intervention Group, n = 29) compared to vaginal moisturizer alone (Control Group, n = 29) over 16 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyspareunia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaginal Dilator | Device | — | UNRESOLVED |
| Vaginal Moisturizer | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaginal Dilator Intervention
- description
- 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.
- interventionNames
- Other: Vaginal Moisturizer
- Device: Vaginal Dilator
- type
- OTHER
- label
- Control (Vaginal Moisturizer Only)
- description
- 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.
- interventionNames
- Other: Vaginal Moisturizer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available