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VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

NCT06840314 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-21

No results posted yet for this study

Summary

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)

Interventions

DEVICE

Pelvic floor therapy

Once randomized to either the vibrating pelvic floor massage arm or the traditional vaginal dilator arm, they will receive instructions on frequency of device use and will use manufacturer's instructions for specifics of device use. We will not dictate more specific instructions on use, nor is this standard of care, as every patient is unique and will need to retain autonomy in terms of how quickly they progress in the use of the product. They will then complete a survey at 4 weeks which includes measures of sexual function and pelvic pain, as well of global impressions of improvement in their symptoms.

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-11-30
Completion
2026-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840314 on ClinicalTrials.gov