NCT05129332

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Between 2012 and 2016, approximately 94,000 women were diagnosed with a gynecologic cancer annually and over 1.2 million women with breast cancer between 2013 and 2017. It is well known that gynecologic and breast cancers, and their treatments including surgery, adjuvant chemotherapy and endocrine therapy, and radiation, result in significant effects on the female reproductive system which can lead to sexual dysfunction. In the U.S., sexual dysfunction among gynecologic oncology patients has been reported to be as high as 90%, and over 70% among breast cancer patients. Patients who receive chemotherapy and/or endocrine therapy commonly experience dyspareunia, vaginal dryness, and challenges with desire and orgasm due to a low estrogen state. In fact, among patients with breast cancer, unaddressed sexual side effects from adjuvant endocrine therapy are one reason for early discontinuation. Hysterectomy and oophorectomy, including for ovarian cancer risk-reduction, can cause similar physical symptoms in addition to psychologic effects like anxiety related to sexual intercourse.

Conditions

• Dyspareunia

Interventions

Type	Name	Description
OTHER	Vaginal Moisturizer	Natural oil-based vaginal moisturizers, like Vitamin E Oil or Coconut Oil, will be applied topically (dime-size amount) on the labia externally and vagina internally nightly, but at least 3 times per week.
DEVICE	Vaginal Dilator	Vaginal dilator will be inserted vaginally and used daily, but at least 3 times per week.

Timeline

• Start date: 2022-08-03
• Primary completion: 2024-02-07
• Completion: 2024-02-07
• First posted: 2021-11-22
• Last updated: 2024-04-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study