VIBRating Vs Traditional Therapy for Treatment of ENTry Dyspareunia

Description

The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device ("Kiwi") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators. The main questions it aims to answer are: 1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators 2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators? Researchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief. Participants will: * Be randomly assigned to use either the Kiwi device or traditional vaginal dilators. * Use the assigned device three times per week for 15 minutes per session over four weeks. * Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.

Conditions

Genito-Pelvic Pain/Penetration Disorder, Dyspareunia, Vaginismus, Pelvic Pain, Vestibulodynia, Vulvodynia (chronic Vulvar Pain)

Study Overview

Study Details

Study overview

The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device ("Kiwi") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators. The main questions it aims to answer are: 1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators 2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators? Researchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief. Participants will: * Be randomly assigned to use either the Kiwi device or traditional vaginal dilators. * Use the assigned device three times per week for 15 minutes per session over four weeks. * Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.

VIBRENT- VIBRating Vs Traditional Therapy for Treatment of ENTry Dyspareunia

VIBRating Vs Traditional Therapy for Treatment of ENTry Dyspareunia

Condition
Genito-Pelvic Pain/Penetration Disorder
Intervention / Treatment

-

Contacts and Locations

Washington

MedStar Health, Washington, District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Assigned female at birth
  • * Age ≥ 18 years old
  • * Genito-pelvic pain/penetration disorder (per ICD-10 diagnosis codes: F52.5 Vaginismus not due to a substance or known physiological condition, F52.6 Dyspareunia not due to a substance or known physiological condition, N94.1 Dyspareunia, N94.2 Vaginismus, N94.81 Vulvodynia)
  • * Current or prior use of a therapeutic vaginal device used to treat GPPPD
  • * Unmanaged genitourinary syndrome of menopause
  • * History of pelvic radiation
  • * History of genital tract malignancy
  • * History of female genital mutilation
  • * History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh
  • * Silicone allergy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medstar Health Research Institute,

Cheryl Iglesia, MD, PRINCIPAL_INVESTIGATOR, Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery

Study Record Dates

2026-03