RECRUITING

VIBRating Vs Traditional Therapy for Treatment of ENTry Dyspareunia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

VIBRENT- VIBRating Vs Traditional Therapy for Treatment of ENTry Dyspareunia

Quick Facts

Study Start:2025-03-01
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06840314

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Assigned female at birth
  2. * Age ≥ 18 years old
  3. * 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)
  1. * Current or prior use of a therapeutic vaginal device used to treat GPPPD
  2. * Unmanaged genitourinary syndrome of menopause
  3. * History of pelvic radiation
  4. * History of genital tract malignancy
  5. * History of female genital mutilation
  6. * History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh
  7. * Silicone allergy

Contacts and Locations

Study Contact

Helen Y Zhang, MD
CONTACT
202-877-6526
helen.y.zhang@medstar.net
Eun Sook Choi, MD
CONTACT
202-877-6526
eunsook.choi@medstar.net

Principal Investigator

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

Study Locations (Sites)

MedStar Health
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • genito-pelvic pain/penetration disorder
  • dyspareunia
  • entry dyspareunia
  • vaginismus
  • pelvic pain
  • female sexual function
  • pain with sex
  • vulvodynia
  • vestibulodynia

Additional Relevant MeSH Terms

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