Vaginal Dilator Therapy Among Women With Gynecologic and Breast Cancers Experiencing Dyspareunia

Dyspareunia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05129332
• Other study ID #: AAAT8915
• Status: Withdrawn
• Phase: N/A
• Start date: August 3, 2022
• Est. completion date: February 7, 2024

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 7, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspareunia

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center / NewYork-Presbyterian Hospital	New York	New York
United States	Women & Infants Hospital of Rhode Island / Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sexual Function based on the PROMIS SexFS Score (Version 2.0)	The Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function (SexFS) assesses over the last 30 days interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure and is customizable so that study designers can select relevant domains and items for their study. Raw scores can range from 2 to 10 ("very" or "very much"), which is then converted to a T-score found in the appendix of the survey. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. The standardized T-score is reported as the final score for each participant for each domain.	Up to 16 weeks
Primary	Difference in Mean Patient-Reported Pain Scores During Sexual Activity	The difference in mean patient-reported pain scores will be calculated, during penetrative sexual activity before and after randomization to vaginal dilator use with vaginal moisturizer or vaginal moisturizer alone. Pain scores will be assessed using a 10cm vial analog scale (VAS), in which 0 indicates no pain and 10 indicates most pain (worst outcome).	Up to 16 weeks
Secondary	Difference in Mean Patient-Reported Pain Scores During Speculum Exam	The difference in mean patient-reported pain scores will be calculated, during speculum exam before and after randomization to vaginal dilator use with vaginal moisturizer or vaginal moisturizer alone. Pain scores will be assessed using a 10cm vial analog scale (VAS), in which 0 indicates no pain and 10 indicates most pain (worst outcome).	Up to 16 weeks