Vibrating Pelvic Floor Device for Painful Intercourse
(VIBRENT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 dilators2. 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the vibrating pelvic floor device generally safe for humans?
The safety of energy-based devices for vaginal symptoms is not well established, and existing data on side effects is limited. In a study of a similar device, some users reported issues like urination and defecation problems due to device displacement, and two cases of superficial vaginal mucosal ulceration were noted, which resolved on their own.12345
How does the vibrating pelvic floor device treatment differ from other treatments for painful intercourse?
The vibrating pelvic floor device is unique because it uses vibration therapy, which has anti-pain properties and is based on physical therapy principles. This approach is different from other treatments like electrical stimulation or vaginal dilators, as it focuses on using vibration to improve sexual function and reduce pain during intercourse.46789
Who Is on the Research Team?
Cheryl Iglesia, MD
Principal Investigator
Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery
Are You a Good Fit for This Trial?
This trial is for sexually active women over 18 with genito-pelvic pain and penetration disorder (GPPPD), which includes conditions like vaginismus, dyspareunia, and vulvodynia. Participants should be willing to use a therapeutic device three times a week.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to use either the Kiwi device or traditional vaginal dilators three times per week for 15 minutes per session over four weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Kiwi
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor