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

NCT05129332 | Withdrawn FDA Device

• 1 other identifier: AAAT8915
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dyspareunia

Keywords

Painful Intercourse; Sexual Dysfunction; Vaginal Dilator; Vaginal Moisturizer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference in Mean Patient-Reported Pain Scores During Speculum Exam

  Up to 16 weeks

Other Outcomes (1)

• Sexual Function based on the PROMIS SexFS Score (Version 2.0)

  Up to 16 weeks

Study Arms (2)

Vaginal Dilator Intervention

EXPERIMENTAL

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.

Other: Vaginal Moisturizer; Device: Vaginal Dilator

Control (Vaginal Moisturizer Only)

OTHER

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.

Other: Vaginal Moisturizer

Interventions

Vaginal Moisturizer OTHER

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.

Also known as: Vitamin E Oil, Coconut Oil

Control (Vaginal Moisturizer Only); Vaginal Dilator Intervention

Vaginal Dilator DEVICE

Vaginal dilator will be inserted vaginally and used daily, but at least 3 times per week.

Vaginal Dilator Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (2)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

Location

Women & Infants Hospital of Rhode Island / Brown University

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Dyspareunia; Sexual Dysfunction, Physiological

Interventions

Vitamin E; Coconut Oil

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Officials

• Jason D. Wright, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sol Goldman Associate Professor of Gynecologic Oncology

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: August 3, 2022
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

US (2)